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Objective: This study aims to evaluate the effect of rehabilitation interventions based on the motive behavioral conversion concept on diabetic foot ulcer patients after artificial dermal transplantation. The focus is on enhancing self-management and quality of life by integrating intrinsic motivation and behavioral changes in postoperative care. It also aims to introduce and clarify this concept for readers less familiar with this approach in diabetic foot ulcer rehabilitation., Methods: The study involved 102 diabetic foot ulcer patients who had undergone artificial dermal transplantation, randomly divided into a control and an observation group. Both groups received standard post-surgical care including antimicrobial agents with alginate supplements and closed negative pressure drainage therapy. The control group underwent conventional rehabilitation, while the observation group received rehabilitation based on motivational behavior transformation. Key evaluation metrics included Visual Analog Scale (VAS) scores, frequency/time of dressing changes, wound healing time, incidence of adverse events, self-care ability scores, and Diabetes-Specific Quality of Life (DSQL) scores, allowing for a comprehensive comparison of outcomes between the two groups., Results: Before the intervention, there was no significant difference in the VAS pain scores between the groups. However, after 7, 10, and 14 days of intervention, the observation group showed a greater reduction in VAS pain scores. The observation group also had shorter dressing change times (12.77 ± 2.18 minutes) and wound healing times (25.77 ± 2.94 days) compared to the control group (16.56 ± 3.25 minutes for dressing change, 27.85 ± 3.26 days for wound healing). There were no significant differences in the frequency of dressing changes or the cumulative incidence of adverse events between the groups. After 6 months, the observation group demonstrated higher self-care ability scores in several domains and lower total DSQL scores, indicating better outcomes in quality of life dimensions., Conclusion: Rehabilitation interventions based on the motive behavioral conversion concept significantly enhanced postoperative recovery, demonstrating potential implications for clinical practices and future research.

Background: Diabetic neuropathy is a condition that can be early diagnosed in DM type 2 patients., Purpose: Evaluate the influence of customized insoles in the plantar pressure of diabetic neuropathy patients when compared to the sham group at baseline and after three and six months., Methods: REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, is a randomized, controlled, double-blinded clinical trial was carried out with a 46-volunteer sample in which participants were randomized to be directed to the intervention and control groups. This study was developed following the standards set for randomized clinical trials (CONSORT). The primary outcome was the analysis of plantar pressure points on the diabetic neuropathy patients' feet using podobarography in the intervention and control group patients. The secondary outcome was the foot functionality in activities of daily living assessed using the FAAM questionnaire in a 6-month follow-up period., Results: No significant differences were found between the groups regarding the primary and secondary outcomes in the 3rd or in the 6th month., Conclusion: Is not possible to state that insoles provided patients with a significant improvement of the footstep structure in the intervention group in comparison to the control group in diabetic neuropathy patients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Smart shoes have ushered in a new era of personalised health monitoring and assistive technologies. Smart shoes leverage technologies such as Bluetooth for data collection and wireless transmission, and incorporate features such as GPS tracking, obstacle detection, and fitness tracking. As the 2010s unfolded, the smart shoe landscape diversified and advanced rapidly, driven by sensor technology enhancements and smartphones' ubiquity. Shoes have begun incorporating accelerometers, gyroscopes, and pressure sensors, significantly improving the accuracy of data collection and enabling functionalities such as gait analysis. The healthcare sector has recognised the potential of smart shoes, leading to innovations such as shoes designed to monitor diabetic foot ulcers, track rehabilitation progress, and detect falls among older people, thus expanding their application beyond fitness into medical monitoring. This article provides an overview of the current state of smart shoe technology, highlighting the integration of advanced sensors for health monitoring, energy harvesting, assistive features for the visually impaired, and deep learning for data analysis. This study discusses the potential of smart footwear in medical applications, particularly for patients with diabetes, and the ongoing research in this field. Current footwear challenges are also discussed, including complex construction, poor fit, comfort, and high cost.

Background: Most interventions to prevent foot ulcers in people with diabetes do not seek to reverse the foot abnormalities that led to the ulcer. Foot-ankle exercise programs target these clinical and biomechanical factors, such as protective sensation and mechanical stress. Multiple RCTs exist investigating the effectiveness of such programs, but these have never been summarised in a systematic review and meta-analysis., Methods: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on foot-ankle exercise programs for people with diabetes at risk of foot ulceration. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed the risk of bias of controlled studies and extracted data. Meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was performed when >2 RCTs were available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE., Results: We included a total of 29 studies, of which 16 were RCTs. A foot-ankle exercise programme of 8-12 weeks duration for people at risk of foot ulceration results in: (a) no increase or decrease risk of foot ulceration or pre-ulcerative lesion (Risk Ratio (RR): 0.56 (95% CI: 0.20-1.57)); (b) no increase or decrease risk of adverse events (RR: 1.04 (95% CI: 0.65-1.67)); (c) not increase or decrease barefoot peak plantar pressure during walking (Mean Difference (MD): -6.28 kPa (95% CI: -69.90-57.34)); (d) no increase or decrease health-related quality of life (no meta-analysis possible). Likely results in increases in ankle joint and first metatarsalphalangeal joint range of motion (MD: 1.49° (95% CI: -0.28-3.26)) may result in improvements in neuropathy signs and symptoms (MD: -1.42 (95% CI: -2.95-0.12)), may result in a small increase in daily steps in some people (MD: 131 steps (95% CI: -492-754)), and may not increase or decrease foot and ankle muscle strength and function (no meta-analysis was possible)., Conclusions: In people at risk of foot ulceration, a foot-ankle exercise programme of 8-12 weeks duration may not prevent or cause diabetes-related foot ulceration. However, such a programme likely improves the ankle joint and first metatarsalphalangeal joint range of motion and neuropathy signs and symptoms. Further research is needed to strengthen the evidence base, and should also focus on the effects of specific components of foot-ankle exercise programs., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Improving tactile sensation by vibrating insoles was recommended to prevent foot ulcers in diabetic peripheral neuropathy (DPN). Lack of an insole design for diabetics was a challenge. Clinical trials on applying vibrating insoles with noise and stochastic resonance (SR) stimulating tactile were also required. In this study, vibrating foot orthoses (VFO) with a total contact design based on orthotics were proposed to provide proper insoles for diabetes. This study aimed to determine if VFO were beneficial at enhancing tactile in DPN. VFO were developed in combination with individual's custom-made foot orthoses and stimulation signals-integrating random 0-100 Hz square wave pulse signals with pseudorandom white noise by a SR approach. Sixty patients with mild-to-severe DPN were randomized to conduct crossover experiments: using and without VFO for 60 minutes stimulation at 90% of individuals' vibration perception threshold (VPT) level. VPT values when using VFO at the 1st and 5th metatarsophalangeal joints of the left foot decreased by 9.35% ( [Formula: see text].001); 9.04% ( [Formula: see text].001), and of the right foot decreased by 7.63% ( [Formula: see text].001); 7.24% ( [Formula: see text].001), respectively. Without VFO, there was no significant difference. Subgroups of mild and moderate DPN tended to benefit greatly from utilizing VFO. VFO can improve tactile in DPN. VFO may contribute to restoring/prolonging tactile and protective sensations, also decreasing peripheral nervous system deterioration. VFO might be useful for neurorehabilitation, and help prevent foot ulcers and disabilities.

Background: For patients with diabetic foot ulcers, offloading is one crucial aspect of treatment and aims to redistribute pressure away from the ulcer site. In addition to offloading strategies, patients are often advised to reduce their activity levels. Consequently, patients may avoid exercise altogether. However, it has been suggested that exercise induces an increase in vasodilation and tissue blood flow, which may potentially facilitate ulcer healing. The aim of this systematic review was to determine whether exercise improves healing of diabetic foot ulcers., Review: We conducted a systematic search of MEDLINE, CINAHL and EMBASE between July 6, 2009 and July 6, 2019 using the key terms and subject headings diabetes, diabetic foot, physical activity, exercise, resistance training and wound healing. Randomised controlled trials were included in this review. Three randomised controlled trials (139 participants) were included in this systematic review. All studies incorporated a form of non-weight bearing exercise as the intervention over a 12-week period. One study conducted the intervention in a supervised setting, while two studies conducted the intervention in an unsupervised setting. Two studies found greater improvement in percentage wound size reduction in the intervention group compared with the control group, with one of these studies achieving statistically significant findings (p < 0.05). The results of the third study demonstrated statistically significant findings for total wound size reduction (p < 0.05), however results were analysed within each treatment group and not between groups., Conclusion: This systematic review found there is insufficient evidence to conclusively support non-weight bearing exercise as an intervention to improve healing of diabetic foot ulcers. Regardless, the results demonstrate some degree of wound size reduction and there were no negative consequences of the intervention for the participants. Given the potential benefits of exercise on patient health and wellbeing, non-weight bearing exercise should be encouraged as part of the management plan for treatment of diabetic foot ulcers. Further research is required to better understand the relationship between exercise and healing of diabetic foot ulcers.

Background: Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care., Methods: The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer-Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up., Results: In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life., Conclusions: There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants' health, well-being and quality of life., Trial Registration: Clinicaltrials.gov , NCT01710774 . Registered October 19th, 2012.

Background: After years of decline, the rate of amputations was reported to increase by 50% in the U.S. population between 2009 and 2015. Few studies have examined the most recent trends in hospitalized diabetic foot ulcer (DFU) in Asian patients. This study aimed to examine recent trends and outcomes in hospitalized DFU at a tertiary diabetes center in Bangkok., Methods: We conducted a retrospective study from consecutive hospitalized DFU admissions from 2014 to 2018 at Theptarin Hospital, a multi-disciplinary diabetes center, led by diabetologists., Results: During the study period, 290 patients (male 57.4%, age 65.5 ± 13.3 years, T2DM 99.4%, DM duration 18.8 ± 11.5 years, A1C 8.6 ± 2.3%) with 350 admissions were included. DFU were classified into neuropathic wounds (38.0%), ischemic wounds (2.6%), and mixed-type wounds (59.4%). The median length of stay was 8 days. Severe DFU (Wagner grade 3-5) composed 68.3% of all DFU and one-third of patients had prior history of amputations. Complete healing was achieved in 73.5% of the patients. Major amputation was performed in 16 (4.6%) and minor amputation was performed in 78 (22.3%) of all DFU. The mortality rate at 1 year after discharge was 12.0%. Advanced diseases with higher co-morbidities were associated with worse outcomes. When compared with our previous published data from 2009 to 2013, the annual rate of ischemic wounds from peripheral arterial diseases (PAD) and severity of DFU were increased in this study period. The major amputation rate slightly decreased from 6.0 to 4.6% but the minor amputation rate increased from 18.7 to 22.3%., Conclusion: The changing trend of DFU provides an excellent outlook into the inadequacies of our current diabetes care systems and global trend of aging population. After considerable successes in reducing major amputations over the past decade, the current analysis revealed a discouraging change in the healing rate of DFU and a stable pattern of major amputation. The prevalence of PAD among Thai patients with DFU increased significantly and affected the results of DFU treatments. Redefined organization of care with multidisciplinary team approach and coordination with referral centers are urgently required to improve outcomes of DFU.

Background: Plantar pressure reduction with the use of cushioning materials play an important role in the clinical management of the diabetic foot. Previous studies in people without diabetes have shown that appropriate selection of the stiffness of such materials can significantly enhance their capacity to reduce pressure. However the significance of optimised cushioning has not been yet assessed for people with diabetic foot syndrome., Research Question: What is the potential benefit of using footwear with optimised cushioning, with regards to plantar pressure reduction, in people with diabetes and peripheral neuropathy?, Methods: Plantar pressure distribution was measured during walking for fifteen people with diabetic foot syndrome in a cohort observational study. The participants were asked to walk in the same type of footwear that was fitted with 3D-printed footbeds. These footbeds were used to change the stiffness of the entire sole-complex of the shoe; from very soft to very stiff. The stiffness that achieved the highest pressure reduction relative to a no-footbed condition was identified as the patient-specific optimum one., Results: The use of the patient-specific optimum stiffness reduced, on average, peak pressure by 46% (±14%). Using the same stiffness across all participants lowered the footwears' capacity for pressure reduction by at least nine percentile points (37% ± 17%); a statistically significant difference (paired samples t-test, t(13) = -3.733, p = 0.003, d = 0.997). Pearson correlation analysis indicated that patient-specific optimum stiffness was significantly correlated with the participants' body mass index (BMI), with stiffer materials needed for people with higher BMI (rs(14) = 0.609, p = 0.021)., Significance: This study offers the first quantitative evidence in support of optimising cushioning in diabetic footwear as part of standard clinical practice. Further research is needed to develop a clinically applicable method to help professionals working with diabetic feet identify the optimum cushioning stiffness on a patient-specific basis., Competing Interests: Declaration of Competing Interest Authors P. Chatzistergos and N. Chockalingam are named co-inventors in a relevant patent (International Application No. PCT/GB2018/052944)., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aims: To assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration., Methods: Twenty-four neuropathic diabetic patients at high risk of foot ulceration were measured for in-shoe plantar pressures during walking in four data-driven custom-made footwear conditions, an athletic shoe and an off-the-shelf non-therapeutic shoe. Two evidence-based footwear conditions (Shoe-A; Insole-A) follow a scientific-based design protocol, are handmade, and use in-shoe plantar pressure guided optimization. One evidence-based insole condition (Insole-B) uses a barefoot plantar pressure and 3D foot shape-based computer-assisted design and manufacturing (CADCAM) routine. And one insole condition (Insole-C) uses a barefoot and in-shoe plantar pressure and 3D foot shape-based CADCAM design and optimization routine. Patient satisfaction was scored on walking comfort, shoe fit, weight and appearance., Results: All data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17-53% relief). Shoe-A and Insole-A showed the lowest metatarsal head peak pressures (mean 112-155 kPa, 90-98% of cases <200 kPa), significantly lower than for Insole-B and Insole-C (mean 119-199 kPa, 52-100% <200 kPa). Patient satisfaction was not significantly different between footwear concepts., Conclusions: This study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention., Competing Interests: The authors have read the journal's policy and the authors of this paper have the following competing interests: WK and IP are paid employees of Penders Voetzorg, Heijthuijsen, the Netherlands. Insole-B, marketed under the name DIABETEC® and manufactured by IETEC Orthopadische Einlagen GmbH, Künzell, Germany, and Insole-C, marketed under the name TrueContour® Therapeutic Insoles and manufactured by DIApedia, State College, Pennsylvania, USA, were provided for this study free of charge by the manufacturing companies. The X-DIAB shoe was provided for this study free of charge by the manufacturer (Podartis Srl, Montebelluna, Italy). There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

The prevalent and long neglected diabetic foot ulcer (DFU) and its related complications rank among the most debilitating and costly sequelae of diabetes. Management of the DFU is multifaceted and requires constant monitoring from patients, caregivers, and healthcare providers. The alarmingly high rates of recurrence of ulcerations in the diabetic foot requires a change in our approach to care and to the vernacular in the medical literature. Our efforts should be directed not only on healing of open wounds, but also on maximizing ulcer-free days for the patient in diabetic foot remission. The increasing development and use of technology within every aspect of our lives represents an opportunity for creative solutions to prevent or better manage this devastating condition. In particular, recent advances in wearable and mobile health technologies appear to show promise in measuring and modulating dangerous foot pressure and inflammation to extend remission and improve the quality of life for these most complex patients. This review article discusses how harnessing wearables and digital technologies may improve the management and optimize prevention of DFUs by identifying high-risk patients for triage and timely intervention, personalizing prescription of offloading, and improving adherence to protective footwear. While still in their infancy, we envisage a future network of skin-worn, jewellery-worn, and implantable sensors that, if allowed to effectively communicate with one another and the patient, could dramatically impact measuring, personalizing, and managing how we and the patients we serve move through our collective world., (© 2020 John Wiley & Sons Ltd.)

Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to help prevent both first and recurrent foot ulcers in persons with diabetes who are at risk for this complication. We searched the available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane databases for original research studies on preventative interventions. We screened trial registries for additional studies not found in our search and unpublished trials. Two independent reviewers assessed data from controlled studies for methodological quality, and extracted and presented this in evidence and risk of bias tables. From the 13,490 records screened, 35 controlled studies and 46 non-controlled studies were included. Few controlled studies, which were of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, there is benefit for the use of daily foot skin temperature measurements, and for therapeutic footwear with demonstrated plantar pressure relief, provided it is consistently worn by the patient. For prevention of ulcer recurrence, there is some evidence for providing integrated foot care, and no evidence for a single session of education.Surgical interventions have been shown effective in selected patients, but the evidence base is small. Foot-related exercises do not appear to prevent a first foot ulcer. A small increase in the level of weight-bearing daily activities does not seem to increase the risk for foot ulceration. The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong. The evidence is weak for the use of other, sometimes widely applied, interventions, and is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer., (© 2020 John Wiley & Sons Ltd.)

Prevention of diabetic foot ulcers is important to reduce the burden of diabetic foot disease. However, we found that ulcer prevention is underexposed in research and clinical practice. Barriers to explain this are seen in patient's goal-setting; in the lack of interdisciplinary teams for ulcer prevention; in sample sizes and funding for research; in industrial engagement; and in limited understanding of ulcer development. Rather than separately solving these barriers, we propose a paradigm shift from stratified healthcare towards personalized medicine for diabetic foot disease. Personalized medicine aims to deliver the right treatment to the right patient at the right time, based on individual diagnostics. Different treatment strategies should be available for different patients, delivered in an integrated, objective, quantitative and evidence-based approach. More than on the classical risk factors of peripheral neuropathy and peripheral artery disease, individual diagnostics should focus on modifiable risk factors for ulceration. This includes structured biomechanical and behavioral profiling, while new research with (big) data science may identify additional risk factors, such as geographical or temporal patterns in ulceration. Industry involvement can drive the development of wearable instruments and assessment tools, to facilitate large-scale individual diagnostics. For a paradigm shift towards personalized medicine in prevention, large-scale collaborations between stakeholders are needed. As each ulcer episode not prevented costs about €10,000 in medical costs alone, such investments can be cost-effective. We hope to see more discussions around this paradigm shift, and increasing investments of energy and money in diabetic foot ulcer prevention in research and clinical practice., (© 2020 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Background: Prevention of diabetic foot ulcers is important. Preventative treatment mostly targets and aims to improve modifiable risk factors of foot ulceration. While effectiveness of interventions in ulcer prevention has been systematically reviewed, their effectiveness in improving modifiable risk factors is unknown., Methods: The available medical scientific literature in PubMed, Excerpta Medica Database, and the Cochrane database was searched for original research studies on six interventions to treat modifiable risk factors for diabetic foot ulceration (ie, education for patients; education for professionals; self-management; pre-ulcer treatment; orthotic interventions; and foot- and mobility-related exercises). We assessed interventions for eight outcomes (ie, patients' knowledge; treatment adherence; professionals' knowledge; pre-ulcers; mechanical stress; neuropathy symptoms; foot/ankle joint mobility; and foot function). Both controlled and noncontrolled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers and extracted and presented in evidence and risk of bias tables., Results: We included 72 publications (26 with a controlled study design and 46 noncontrolled). We found that structured education may improve foot self-care behaviour of patients, yearly foot examinations, and foot disease knowledge of health care professionals. Callus removal reduces peak plantar pressure. Custom-made therapeutic footwear can be effective in reducing plantar pressure and may reduce callus. Foot- and mobility-related exercises may improve neuropathy symptoms and foot and ankle joint range of motion, while they do not seem to reduce peak plantar pressure; evidence for their effect on foot strength is conflicting., Conclusions: Structured education for patients and health care professionals, callus removal, custom-made therapeutic footwear, and foot- and mobility-related exercises may be beneficial for improving modifiable risk factors for foot ulceration. However, we generally found low quality of evidence for interventions targeting modifiable risk factors for ulceration in persons with diabetes, with frequently inconsistent or limited results available per intervention and outcome., (© 2020 John Wiley & Sons Ltd.)

Diabetic foot disease greatly impacts both affected patients and society, but remains the "Cinderella" of diabetes-related complications. However, recent progress in research and guideline development have led to increased awareness of the problem and improved clinical outcomes. Thus, it is time for a shift in global perception of this increasingly prevalent problem. In this special issue, we present 7 up-to-date clinical guidelines and 10 systematic reviews developed by the International Working Group on the Diabetic Foot, together with 17 informative and stimulating related papers. These guidelines offer new recommendations on ulcer classification, diagnosis of infection severity, and vascular assessment, to assist in ulcer risk stratification, diagnosis and interdisciplinary communication. Key developments include providing guidance on methodological assessment of research papers; expanding the evidence base for ulcer treatment by the use of wound products and offloading treatment and suggestions for improving ulcer prevention through technological advances in patient monitoring of risk factors and footwear. The 17 invited papers discuss related topics ranging from stem cell research to patient psychology and describe the way forward in diabetic foot care. While there is much more to learn, the new knowledge of underlying pathways, advancements in diagnosis, treatment and prevention presented in this supplement should help improve outcomes and reduce the great and growing burden of diabetic foot disease., (© 2020 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Clinicians and patients face a dilemma in understanding how best to resume walking after a healed diabetic neuropathic ulcer. The objectives of this brief review are to: provide context for the patient's health and mobility status; propose 5 suggestions to safely and effectively progress mobility following a healed foot ulcer; and to consider topics for future research to improve care in this area. Rates of ulcer recurrence and mortality are high, and activity is low following a diabetic foot wound. Medical and rehabilitation approaches have emphasized protection of the insensitive, fragile foot with the hope to prevent subsequent harm to the foot and person. In particular, the 1-2 months following wound unloading and "healing" have the greatest risk for ulcer recurrence. While early protection should be emphasized, a growing body of evidence suggests that over-protection of the foot and limited walking can be harmful, presumably because of the negative effects of prolonged immobility and stress protection. Multiple recent studies report the ability of exercise and walking to have a positive effect on various diabetic foot outcomes without additional harm. Much less is known about how an ulcerated foot can resume walking after the wound is healed. This review integrates available guidelines, evidence, and precautions to suggest advice on how best to resume and progress walking in this population at high risk for ulcer recurrence., (© 2019 John Wiley & Sons Ltd.)

Multiple disciplines are involved in the management of diabetic foot disease, and a common vocabulary is essential for clear communication. Based on the systematic reviews of the literature that form the basis of the International Working Group on the Diabetic Foot (IWGDF) Guidelines, the IWGDF has developed a set of definitions and criteria for diabetic foot disease. This document describes these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research to facilitate clear communication between professionals., (© 2020 John Wiley & Sons Ltd.)

Supported by evidence-based guidelines, custom-made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom-made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate-to-high risk of developing a foot ulcer, for whom custom-made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face-to-face meetings to develop a footwear design algorithm and evidence-based pressure-relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe-specific and insole (orthosis)-specific features were defined. Most insole-related features and some shoe-related features were evidence based, whereas most shoe-related features were consensus based. The pressure-relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure-relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate-to-high-risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers., (© 2019 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the prevention of foot ulceration in persons with diabetes and updates the 2015 IWGDF prevention guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We recommend to screen a person at very low risk for ulceration annually for loss of protective sensation and peripheral artery disease and persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate the at-risk patient about appropriate foot self-care and treat any pre-ulcerative sign on the foot. Instruct moderate-to-high risk patients to wear accommodative properly fitting therapeutic footwear, and consider instructing them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking to prevent plantar foot ulcer recurrence. In patients that fail non-surgical treatment for an active or imminent ulcer, consider surgical intervention; we suggest not to use a nerve decompression procedure. Provide integrated foot care for high-risk patients to prevent ulcer recurrence. Following these recommendations will help health care professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days, and to reduce the patient and health care burden of diabetic foot disease., (© 2020 John Wiley & Sons Ltd.)

Diabetic foot disease is a source of major patient suffering and societal costs. Investing in evidence-based international guidelines on diabetic foot disease is likely among the most cost-effective forms of health care expenditure, provided the guidelines are outcome focused, evidence based, and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2019 updates are based on formulating relevant clinical questions and outcomes, rigorous systematic reviews of the literature, and recommendations that are specific, and unambiguous along with their transparent rationale, all using the Grading of Recommendations Assessment Development and Evaluation (GRADE) framework. We herein describe the development of the 2019 IWGDF guidelines on the prevention and management of diabetic foot disease, which consists of six chapters, each prepared by a separate working group of international experts. These documents provide guidelines related to diabetic foot disease on prevention; offloading; peripheral artery disease; infection; wound healing interventions; and classification of diabetic foot ulcers. Based on these six chapters, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. We believe that adoption and implementation of the 2019 IWGDF guidelines by health care providers, public health agencies, and policymakers will result in improved prevention and management of diabetic foot disease and a subsequent worldwide reduction in the patient and societal burden this disease causes., (© 2020 John Wiley & Sons Ltd.)

Diabetic foot disease results in a major global burden for patients and the health care system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In 2019, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification, and treatment of diabetic foot disease, based on the six IWGDF Guideline chapters. We also describe the organizational levels to successfully prevent and treat diabetic foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of health care professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower extremity amputations. We hope that these updated practical guidelines continue to serve as reference document to aid health care providers in reducing the global burden of diabetic foot disease., (© 2020 John Wiley & Sons Ltd.)

Background: Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers., Methods: We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis., Results: We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia., Conclusion: Strong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas., (© 2020 John Wiley & Sons Ltd.)

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people with diabetes and updates the previous IWGDF guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a nonremovable knee-high offloading device is the first choice of offloading treatment. A removable knee-high and removable ankle-high offloading device are to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to nonremovable offloading exist. Appropriately, fitting footwear combined with felted foam can be considered as the fourth-choice offloading treatment. If non-surgical offloading fails, we recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment for healing ulcers that are complicated with infection or ischaemia and for healing plantar heel ulcers. Offloading is arguably the most important of multiple interventions needed to heal a neuropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalization, and amputation., (© 2020 John Wiley & Sons Ltd.)

Purpose: To examine a non-weightbearing exercise program for persons with severe peripheral neuropathy (PN) and a diabetic foot ulcer in terms of feasibility and safety. Materials and methods: Five men (mean (SD) age of 68.2 (7.1) years) with diabetes, severe peripheral neuropathy and an active foot ulcer, participated in a 10-week exercise program. Program adherence, patient satisfaction, healing of foot ulcers, adverse advents, ability to perform activities of daily life, and changes in muscle strength were assessed. Results: All participants completed the program with a session attendance from 85 to 95%, and with high satisfaction (≥9 points on a 10-point numeric rating scale). Only minor adverse events occurred, and ulcers were reduced for all participants, from a median of 1.9 (IQR, 1.1-7.3) cm 2 to 0.0 (0.0-3.0) cm 2 . The distance on stationary bike was improved from a mean (SD) of 3.30 (1.1) to 5.36 (0.5) kilometers, and strength training loads were progressed. Ability to perform in self-selected activities of daily living improved from a median of 4.3 (2-5) to 6.7 (5-8) on the Patient Specific Functional Scale (0-10 points), while maximal isometric knee-extension muscle strength improved with 23%. Conclusions: A non-weightbearing exercise program for people with diabetes, severe peripheral neuropathy and foot ulcers seems feasible and safe. Further studies are needed to confirm these findings.Implications for rehabilitationAn exercise program designed for people with severe peripheral neuropathy and diabetic foot ulcers can be safe by means of not compromising healing of foot ulcers.Feasible in terms of attendance and progression.An alternative to passive waiting for ulcer to heal in a population already deconditioned.

Aims: To develop and validate the content of a free web-based software (desktop and mobile applications) for the self-management of and customised foot-ankle exercises for people with diabetes and diabetic neuropathy., Methods: The development of the programme was based on gamification principles and addressed three main areas: foot care recommendations; self-assessment of feet according to the main complications of diabetic neuropathy; and customised foot-ankle exercises to strengthen muscles, increase the range of motion and improve functionality. The content was validated using the Delphi methodology and a quantitative approach in two rounds with diabetes specialists (n = 9) and users with diabetes (n = 20). A 70% approval rate was considered sufficient in the second round for final validation purposes. The data analysis was conducted using descriptive statistics, absolute and relative frequencies and the content-validity index (CVI)., Results: Among specialists, the CVI was 0.812 after the first round, and final approval was 100% after the second round. Among users, the CVI was 0.902 in the first round, and the final approval was 97%., Conclusion: This free access web software was developed based on the high agreement rating between specialists and users and has the potential to prevent complications arising from diabetic polyneuropathy. It allows for self-monitoring and promotes personalised exercises, following a preventive model that can be applied in primary and secondary care services as a complementary treatment for chronic complications. However, further steps to validate the software in a larger population are recommended., Competing Interests: The authors have declared that no competing interests exist.

Uncontrolled high blood sugar levels leads to diabetic neuropathy, which is usually develops slowly. Damaged nerves stop sending messages or may send message slowly at the wrong times. The propsed model is an insole for individuals with peripheral neuropathy conditions, where the peak plantar pressure value is measured at specified locations of the foot by means of a pressure sensor, which can be accessed via  a mobile applications; Simultaneously, a stimulation is given at acupressure points of the foot to relieve pain at definite intervals of time, based on the signals from the controller. A controller is being used to perform these operations which will be transmitted to the mobile application via Bluetooth terminal., (Copyright © 2019 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Background: Diabetic foot ulceration (DFUs) is increasingly prevalent in Singapore. Appropriate management is important since DFU brings with it an associated risk for lower limb amputations, high morbidity rates and costs. Footwear prescription has been a part of clinical guidelines to manage DFUs. However, adherence to prescription footwear is typically poor amongst patients. Reasons for this have been explored in Northern American and Western European studies, but not in Singapore's context. As cultural and climate differences limit transferability of findings from existing studies to individuals in Singapore, this study aims to explore the lived experiences of participants with diabetes using prescription footwear in Singapore., Methods: This was a qualitative study using interpretative phenomenological analysis (IPA) to understand some people's personal experience of using off the shelf prescription footwear. A total of 8 people with diabetes who received prescription footwear as part of their diabetic foot management were recruited. All participants provided written consent and took part in a semi-structured interview lasting up to an hour. Interviews were digitally recorded, transcribed and analysed using an IPA approach., Findings and Discussion: The analysis identified the super-ordinate themes of 1) security and 2) acceptance with sub-themes of 1.1) risk and 1.2) protection and 2.1) personal and social acceptance and 2.2) social and cultural acceptance respectively that inter-related to influence how participants' made footwear decisions. This process of evaluation was portrayed to be a fluctuant one, making it difficult to predict yet necessary to understand. A modified seesaw model of adherence is suggested to explain this decision-making process., Conclusions: The complex manner by which participants grappled with security and acceptance is often overlooked when footwear is prescribed, highlighting a need for a more collaborative clinician-patient partnership for these issues to surface in clinical practice. Furthermore, prescription footwear should be seen more holistically. Empowering patients with choice to select from a range of therapeutic yet normalised footwear could increase the level of security and acceptance they experience with its use., Competing Interests: ST is a MSc student at the University of Brighton, UK, and a Senior Podiatrist at Ng Teng Fong General Hospital, Singapore. TT is a Senior Lecturer in Podiatry at the University of Brighton. HH is a Senior Lecturer in Physiotheraphy at the University of Brighton.Ethics approval was obtained from the University of Brighton’s Faculty of Health Research Ethics and Governance Committee (FHREGC) and from the National Healthcare Group Domain Specific Review Board (NHGDSRB) in Singapore. All participants consented to take part in this study and the use of quotes in publication.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Objective: The primary aim was to determine the productivity increase using digital imagery for better documentation and analysis. A case series was done in a specialised care centre with patients managed with advanced dressings and using state-of-the-art smartphone technology for documentation to save costs and time., Method: Wounds were cleansed and debrided before using the application to photograph, document, measure and analyse the wounds. The smartphone app was oriented parallel to the plane of the wound, where possible, to obtain accurate measurements. A longitudinal study report was generated for each wound and showed the progress of the wound healing until the wound was closed., Results: A sample size of 60 patients consisting of wounds from different locations, and a total of 203 measurements and analyses were conducted over a period of seven months. The wound monitoring app proved to be effective for wound monitoring and required less than two hours' training. A report summary of wounds recorded could also be generated automatically through the dashboard. All 60 patients' cases were automatically recorded, measured and presented into reports for use in clinical analysis. There was a significant time savings (27 hours per day for a specialised care centre with 10 nurses) increase over manual wound documentation and measuring methods., Conclusion: The app provided a non-contact, easy to use, reliable and accurate smart wound management solution for clinicians and physicians to track wound healing in patients. The app could also be used by patients and caregivers for home monitoring of their wounds.

Introduction: Foot offloading is the mainstay treatment for plantar diabetic foot ulcers (DFUs)., Objective: This multicenter, single-blinded, randomized controlled trial evaluates the efficacy of a total offloading foot brace for healing plantar DFUs., Materials and Methods: Seventeen patients were randomized to standard therapy (ie, reducing stress and pressure via mechanical offloading) or offloading foot brace. Comparison of plantar pressures was performed using digital pressure sensing films. The ulcers were assessed by physical inspection and digital planimetry of photographs., Results: Reductions in peak plantar pressures ranged from 67.3% to 89.4% (P = .09). Healing at weeks 12 to 15 had minimal differences (brace vs. control: 71.7% vs. 80.3%, respectively). Although not significant, earlier periods of the brace versus the control demonstrated faster wound healing in weeks 2 to 5 (36.0% vs. 6.8%, respectively) and weeks 6 to 9 (50.7% vs. 17.0%, respectively)., Conclusions: The total offloading foot brace minimizes plantar pressure, allowing for early healing of DFUs, and optimizations in brace design may enhance healing of plantar DFUs.

Diabetes may cause different foot problems, which could easily lead to infection, ulcers, and increasing risk of amputation due to nerve or vascular injury. In order to reduce the risk of amputation, Buerger's exercise is frequently used for rehabilitation to improve the blood circulation in lower limbs. However, it is difficult to evaluate the rehabilitation efficiency with Buerger's exercise objectively. In this study, a novel non-invasively optical system is developed to non-invasively monitor the change of the foot blood circulation before and after long-term Buerger's exercise. Radial basis function neural network is also used for classifying the healthy and diabetic groups from the change of relative total hemoglobin (HbT) concentration and tissue oxygen saturation (StO2) and providing an index to evaluate the rehabilitation efficiency with Buerger's exercise. Finally, the experimental results show that the relative HbT concentration and StO2 in lower limbs corresponding to different groups are significantly different and could be used as the factors for the classification of healthy subjects and diabetic foot patients. Moreover, the tendency of the relative HbT concentration and StO2 rise after the long-term rehabilitation with Buerger's exercise.

Background: Diabetic foot management is a challenge for reconstructive surgeons because it combines dramatically decreased circulation and chronic infection. The goal of managing this condition is to maximize viable tissue; however, unsatisfactory results, such as extremity amputation, are unavoidable in some cases. For appropriate management, thorough understanding of diabetic foot and the phased approach to its management is needed. The purpose of this study is to introduce an optimal algorithm for diabetic foot management by analyzing cases >12 years., Methods: A total of 274 patients with diabetic foot at Hanyang University Guri Hospital from 2005 to 2017 were reviewed. The management process was divided into 5 steps: patient evaluation, wound preparation, improving vascularity, surgery and dressing, and rehabilitation. Patient evaluation included a microbial culture, evaluation of vascularity, and an osteomyelitis assessment. During wound preparation, debridement and negative-pressure wound therapy were performed. Vascularity was improved by radiological intervention or surgical method. Surgery and dressing were performed depending on the indications. Rehabilitation was started after complete wound healing., Results: An infection was confirmed in 213 of 263 patients (81.0%). Of 74 cases in which a vascular study was performed, 83.8% showed arterial occlusion. When surgery was performed with complete eradication of the infection in 155 patients, the rate of revision surgery was 20.6%. The revision rate after surgery with a remnant infection of 66 patients was 40.9% (P = .0003). When surgery was performed after successful revascularization for improving blood flow of 47 patients, the rate of revision surgery was 21.3%. In contrast, the revision rate after surgery with unsuccessful or no revascularization of 174 patients was 28.2% (P = .359)., Conclusion: Diabetic foot is a debilitating disease arising from multifactorial process. As its management is complex, a comprehensive but accessible treatment algorithm is needed for successful results. For this reason, the appropriate algorithm for diabetic foot management introduced in this study is significant.

Background: Footwear can have both a positive and negative impact on lower limb health and mobility across the lifespan, influencing the risk of foot pain, ulceration, and falls in those at risk. Choice of footwear can be influenced by disease as well as sociocultural factors, yet few studies have investigated the types of footwear people wear and the profiles of those who wear them. The aim of this study was to investigate the prevalence and factors associated with outdoor footwear type worn most often in a representative inpatient population., Methods: This study was a secondary data analysis of a cohort of 733 inpatients that is highly representative of developed nations' hospitalised populations; 62 ± 19 years, 55.8% male, and 23.5% diabetes. Socio-demographic, medical history, peripheral arterial disease, peripheral neuropathy, foot deformity, foot ulcer history, amputation history and past foot treatment variables were collected. Participants selected the footwear type they mostly wore outside the house in the previous year from 16 types of footwear. Multivariate logistic regression identified independent factors associated with outdoor footwear types selected., Results: The most common outdoor footwear types were: running shoes (20%), thongs/flip flops (14%), walking shoes (14%), sandals (13%) and boots (11%). Several socio-demographic, medical history and foot-related factors were independently associated (Odds Ratio; 95% Confidence Interval)) with different types of footwear. Running shoes were associated with male sex (2.7; 1.8-4.1); thongs with younger age (0.95 for each year; 0.94-0.97), being female (2.0; 1.2-3.1) and socio-economic status (3.1; 1.2-7.6); walking shoes with arthritis (1.9; 1.2-3.0); sandals with female sex (3.8; 2.3-6.2); boots with male sex (9.7; 4.3-21.6) and inner regional (2.6; 1.3-5.1) and remote (3.4; 1.2-9.5) residence (all, p  < 0.05)., Conclusions: We profiled the types of outdoor footwear worn most in a large diverse inpatient population and the factors associated with wearing them. Sex was the most consistent factor associated with outdoor footwear type. Females were more likely to wear thongs and sandals and males boots and running shoes. Overall, this data gives insights into the socio-demographic, medical and other health factors that are related to footwear choice in a large diverse population primarily of older age., Competing Interests: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Few studies have evaluated the long-term clinical outcomes of Charcot foot. The present study evaluated the long-term effects of Charcot foot in a population treated with early weightbearing in a removable Charcot restraint orthotic walker. A retrospective study of 62 consecutive patients (74 feet) treated for Charcot foot from January 2003 to March 2014 was conducted. Of the 74 affected feet, 48 (64.9%) had developed an ulcer. The total amputation rate was 25.7% (19 feet), and 11 feet (14.9%) underwent major amputations. The mortality rate was 19.4% (12 patients). Low Short-Form 36-item scores for all subcomponents were found. The major amputation rate was significantly greater for hindfoot than for midfoot manifestations. Charcot foot results in a high risk of chronic ulceration. The hindfoot Charcot manifestation was associated with a high rate of major amputations. Early weightbearing in a Charcot restraint orthotic walker as treatment of Charcot foot was not supported by the results from the present study., (Copyright © 2017 The American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction: As the majority of diabetic foot ulcerations (DFUs) occur on the plantar foot, excessive pressure is a major contributing factor to delayed healing. The gold standard for offloading is the total contact cast (TCC); yet, TCC use is contraindicated in patients with ischemia. Lower extremity ischemia typically presents in the more severe end stages of peripheral arterial disease (PAD). As PAD exists on a severity spectrum from mild to severe, designation of a clear cutoff where TCC use is an absolute contraindication would assist those who treat DFUs on a daily basis., Objective: The aim of this study is to determine if a potential cutoff value for PAD where TCC use would be an absolute contraindication could be ascertained from a retrospective case series and a systematic literature review of patients with PAD in which treatment included TCC use., Materials and Methods: A retrospective cases series and systematic review of patients with mild to moderate PAD treated with a TCC was performed. All reports of TCC use in patients with PAD and a neuropathic ulceration that included results of noninvasive vascular studies were included., Results: Results suggested that TCC use is a viable treatment modality for pressure-related DFUs in patients with an ankle pressure ≥ 80 mm Hg, a toe pressure ≥ 74 mm Hg, an ankle-brachial index ≥ 0.55, or a toe-brachial index ≥ 0.55., Conclusions: Vascular evaluation, individual risk/benefit analysis, close follow-up, and patient education are essential components of TCC use in these patients. Repeat vascular evaluation is recommended if the wound fails to progress towards resolution with TCC use.

Background: The aim of this paper was to create an updated Australian guideline on footwear for people with diabetes., Methods: We reviewed new footwear publications, (inter)national guidelines, and consensus expert opinion alongside the 2013 Australian footwear guideline to formulate updated recommendations., Result: We recommend health professionals managing people with diabetes should: (1) Advise people with diabetes to wear footwear that fits, protects and accommodates the shape of their feet. (2) Advise people with diabetes to always wear socks within their footwear, in order to reduce shear and friction. (3) Educate people with diabetes, their relatives and caregivers on the importance of wearing appropriate footwear to prevent foot ulceration. (4) Instruct people with diabetes at intermediate- or high-risk of foot ulceration to obtain footwear from an appropriately trained professional to ensure it fits, protects and accommodates the shape of their feet. (5) Motivate people with diabetes at intermediate- or high-risk of foot ulceration to wear their footwear at all times, both indoors and outdoors. (6) Motivate people with diabetes at intermediate- or high-risk of foot ulceration (or their relatives and caregivers) to check their footwear, each time before wearing, to ensure that there are no foreign objects in, or penetrating, the footwear; and check their feet, each time their footwear is removed, to ensure there are no signs of abnormal pressure, trauma or ulceration. (7) For people with a foot deformity or pre-ulcerative lesion, consider prescribing medical grade footwear, which may include custom-made in-shoe orthoses or insoles. (8) For people with a healed plantar foot ulcer, prescribe medical grade footwear with custom-made in-shoe orthoses or insoles with a demonstrated plantar pressure relieving effect at high-risk areas. (9) Review prescribed footwear every three months to ensure it still fits adequately, protects, and supports the foot. (10) For people with a plantar diabetic foot ulcer, footwear is not specifically recommended for treatment; prescribe appropriate offloading devices to heal these ulcers., Conclusions: This guideline contains 10 key recommendations to guide health professionals in selecting the most appropriate footwear to meet the specific foot risk needs of an individual with diabetes., Competing Interests: Not applicableNot applicableJJvN, PAL, DGA, SAB, RF, KH, EK, MM, BP, KP, JP, PRW: nothing to declare in relation to this manuscript. KHS runs a Pedorthic Clinic in Dee Why, NSW, Australia. HBM is Editor-in-Chief of Journal of Foot and Ankle Research. It is journal policy that editors are removed from the peer review and editorial decision making processes for papers they have co-authored.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Although free flap is gaining popularity for the reconstruction of diabetic foot ulcers, it is unclear whether free flap reconstruction increases the chances of postoperative independent ambulation. The aim of this study is to evaluate the relationship between free flap success and postoperative ambulation., Methods: This study reviewed 23 cases of free flap reconstruction for diabetic foot ulcers between January 2007 and March 2014. Free rectus abdominis, latissimus dorsi, and anterolateral thigh flaps were used in ten, eight, and five patients, respectively. A comparison was made between free flap success and postoperative independent ambulation using Fisher's exact test., Results: Two patients developed congestive heart failure with fatal consequences within 14 days postoperatively, resulting in an in-hospital mortality rate of 8.7%. Five patients lost their flaps (21.7%). Of the 16 patients who had flap success, 12 achieved independent ambulation. Five patients with flap loss did not achieve independent ambulation, except one patient who underwent secondary flap reconstruction using a distally based sural flap. Fisher's exact test revealed that independent ambulation was associated with free flap success (p = 0.047)., Conclusion: The present study indicates that free flap reconstruction may increase the possibility of independent ambulation for patients with extensive tissue defects due to diabetic ulcers. Intermediate limb salvage rates and independent ambulation rates were favourable in patients with successful reconstruction. The use of foot orthoses and a team approach with pedorthists were effective to prevent recurrence.

Background and Objectives: The majority of patients with diabetes foot ulcer have peripheral arterial disease. The technique of near infrared spectroscopy (NIRS) used to monitor the dorsal foot blood circulation condition is by measuring the absorption differences between oxy-hemoglobin and deoxy-hemoglobin., Study Designs/materials and Methods: Patients with diabetic foot ulcer (DFU) treated in our wound care center were divided into two sub-groups based on the Duplex ultrasound or angiography. Patients with peripheral arterial disease (PAD) and non-peripheral arterial disease were divided into group A1 and A2, respectively. We applied wireless NIRS on patients' dorsal foot to assess the peripheral circulation by continuously detect the signal penetrating the tissue while patients were asked to do Buerger's exercise. The same procedure was also repeated on 15 healthy participants as control group B., Results: From January to August 2015, 30 patients with DFU (Group A) were enrolled in the study, 9 patients in Group A1 and 21 patients in Group A2. Tissue concentration of oxygenated hemoglobin (HbO2) in each group varied in a similar trend among five stages of Buerger's exercise. HbO2 concentration increases at post-exercise stages in all groups (P = 0.006 in Group A1, P = 0.223 in Group A2, P = 0.03 in Group B), however, there were significant difference in both pre- and post-exercise stages (P = 0.001 and P = 0.01, respectively) between Group A and B. Moreover, significant differences (P = 0.0009) of HbO2 were also found between Group A1 and A2 in pre-exercise status, but no significant difference (P = 0.294) was found in post-exercise status. Similar results were also found in total hemoglobin (Hb) concentration analyses., Conclusions: Buerger's exercise could increase peripheral HbO2 and total Hb circulation in patients with diabetes foot ulcer. The NIRS could continuously and quantitatively monitor real-time peripheral circulation in postural changes and is novel to rehabilitation program. A larger scale study to prove the accuracy of NIRS system in detecting peripheral circulation could be worthwhile. Lasers Surg. Med. 49:652-657, 2017. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Review Question/objective: The aim of this systematic review is to identify the key design features of footwear and insoles that are used to offload the plantar surface of the foot to prevent foot ulceration in adults with diabetes.More specifically, the objectives are to identify the key design features of footwear and insoles to offload the plantar surface of the foot with regard to.

Background: Over 1 in 3 older people with diabetes sustain a fall each year. Postural instability has been identified as independent risk factor for falls within people with Diabetic Peripheral Neuropathy (DPN). People with DPN, at increased risk of falls, are routinely required to wear offloading insoles, yet the impact of these insoles on postural stability and postural control is unknown. The aim of this study was to evaluate the effect of a standard offloading insole and its constituent parts on the balance in people with DPN., Methods: A random sample of 50 patients with DPN were observed standing for 3 × 30 s, and stepping in response to a light, under five conditions presented in a random order; as defined by a computer program; 1) no insole, 2) standard diabetic: a standard offloading insole made from EVA/poron®, and three other insoles with one design component systematically altered 3) flat: diabetic offloading insole with arch fill removed, 4) low resilient memory: diabetic offloading insole with the cover substituted with low resilience memory V9, 5) textured: diabetic offloading insole with a textured PVC surface added (Algeos Ltd). After each condition participants self-rated perceived steadiness., Results: Insole design effected static balance and balance perception, but not stepping reaction time in people with DPN. The diabetic and memory shaped insoles (with arch fill) significantly increased centre of pressure velocity (14 %, P  = 0.006), (13 %, P  = 0.001), and path length (14 %, P  = 0.006), (13 %, P  = 001), when compared to the no insole condition. The textured shaped and flat soft insole had no effect on static balance when compared to the no insole condition ( P  > 0.05)., Conclusion: Insoles have an effect on static balance but not stepping reaction time. This effect is independent of neuropathy severity. The addition of a textured cover seems to counter the negative effect of an arch fill, even in participants with severe sensation loss. Static balance is unaffected by material softness or resilience. Current best practice of providing offloading insoles, with arch fill, to increase contact area and reduce peak pressure could be making people more unstable. Whilst flat, soft insoles maybe the preferable design option for those with poor balance. There is a need to develop an offloading insole that can reduce diabetic foot ulcer risk, without compromising balance.

Background: Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot., Methods/design: ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017., Conclusion: ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).

Diabetic foot ulceration is a serious complication of diabetes mellitus worldwide and the most common cause of hospitalization in diabetic patients. The etiology of diabetic foot ulcerations is complex due to their multifactorial nature; in the pathophysiology of diabetic foot ulceration polyneuropathy is important. Proper adherence to standard treatment strategies and interdisciplinary cooperation can reduce the still high rates of major amputations.

Unlabelled: Adequate stabilization and off-loading of the lower limb is an integral part of postoperative care for patients with the diabetic foot. Off-loading can accelerate the healing process and reduce the number of complications and reoperations. The newly introduced method of the performance of removable contact splints (modified contact removable casts) seems to fulfil a number of requirements for stabilization and off-loading devices - the method is safe and can actually reduce the healing time and the number of reoperations in patients with the diabetic foot., Key Words: diabetic foot - off-loading - splints.

Background: Although great progress has been made in managing diabetic foot disease, it continues to carry significant morbidity and mortality. Obstructive sleep apnoea (OSA) and diabetes frequently coexist and recent studies suggest significant under-recognition of OSA in those with diabetes. There are no current reports on the direct clinical impact of OSA on acute or chronic diabetic foot ulcer healing., Case Report: We describe three cases with Type 2 diabetes and a mean BMI of 50 kg/m(2) in whom we believe undiagnosed severe OSA may have impeded the rate of recovery of acutely infected foot ulcers. Despite standard care whilst in hospital with optimization of glycaemia, daily wound care, ulcer offloading techniques including casting, it was difficult to achieve satisfactory granulation in the first two cases with previously unrecognized and hence untreated severe OSA (Apnoea-Hypopnea Index > 30) until correction had been achieved through continuous positive airway pressure therapy (CPAP). In the third case, despite all optimization techniques, healing has not been achieved and individuals' reluctance to consider CPAP may be one possible factor., Discussion: We observe in three severely obese individuals with diabetes that untreated severe OSA may have contributed to delayed wound healing. We also observed an improvement in two individuals after institution of CPAP therapy. Clinicians managing the diabetic foot should consider investigating the presence of OSA in non-healing or slowly progressive foot ulcers when all other factors have been fully optimized., (© 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.)

With the growing demand for the specialized care of wounds, there is an ever expanding abundance of wound care modalities available. It is difficult to identify which products or devices enhance wound healing, and thus, a critical and continual look at new advances is necessary. The goal of any wound regimen should be to optimize wound healing by combining basic wound care modalities including debridement, off-loading, and infection control with the addition of advanced therapies when necessary. This review takes a closer look at current uses of negative pressure wound therapy, bioengineered alternative tissues, and amniotic membrane products. While robust literature may be lacking, current wound care advances are showing great promise in wound healing., (Copyright © 2016 John Wiley & Sons, Ltd.)

The treatment of diabetic foot ulceration is complex with multiple factors involved, and it may often lead to limb amputation. Hence, a multidisciplinary approach is warranted to cover the spectrum of treatment for diabetic foot, but in complex wounds, surgical treatment is inevitable. Surgery may involve the decision to preserve the limb by reconstruction or to amputate it. Reconstruction involves preserving the limb with secure coverage. Local flaps usually are able to provide sufficient coverage for small or moderate sized wound, but for larger wounds, soft tissue coverage involves flaps that are distantly located from the wound. Reconstruction of distant flap usually involves microsurgery, and now, further innovative methods such as supermicrosurgery have further given complex wounds a better chance to be reconstructed and limbs salvaged. This article reviews the microsurgery involved in reconstruction and introduces the new method of supermicrosurgery., (Copyright © 2016 John Wiley & Sons, Ltd.)

Non-invasive tests for the detection of peripheral artery disease (PAD) among individuals with diabetes mellitus are important to estimate the risk of amputation, ulceration, wound healing and the presence of cardiovascular disease, yet there are no consensus recommendations to support a particular diagnostic modality over another and to evaluate the performance of index non-invasive diagnostic tests against reference standard imaging techniques (magnetic resonance angiography, computed tomography angiography, digital subtraction angiography and colour duplex ultrasound) for the detection of PAD among patients with diabetes. Two reviewers independently screened potential studies for inclusion and extracted study data. Eligible studies evaluated an index test for PAD against a reference test. An assessment of methodological quality was performed using the quality assessment for diagnostic accuracy studies instrument. Of the 6629 studies identified, ten met the criteria for inclusion. In these studies, the patients had a median age of 60-74 years and a median duration of diabetes of 9-24 years. Two studies reported exclusively on patients with symptomatic (ulcerated/infected) feet, two on patients with asymptomatic (intact) feet only, and the remaining six on patients both with and without foot ulceration. Ankle brachial index (ABI) was the most widely assessed index test. Overall, the positive likelihood ratio and negative likelihood ratio (NLR) of an ABI threshold <0.9 ranged from 2 to 25 (median 8) and <0.1 to 0.7 (median 0.3), respectively. In patients with neuropathy, the NLR of the ABI was generally higher (two out of three studies), indicating poorer performance, and ranged between 0.3 and 0.5. A toe brachial index <0.75 was associated with a median positive likelihood ratio and NLRs of 3 and ≤ 0.1, respectively, and was less affected by neuropathy in one study. Also, in two separate studies, pulse oximetry used to measure the oxygen saturation of peripheral blood and Doppler wave form analyses had NLRs of 0.2 and <0.1. The reported performance of ABI for the diagnosis of PAD in patients with diabetes mellitus is variable and is adversely affected by the presence of neuropathy. Limited evidence suggests that toe brachial index, pulse oximetry and wave form analysis may be superior to ABI for diagnosing PAD in patients with neuropathy with and without foot ulcers. There were insufficient data to support the adoption of one particular diagnostic modality over another and no comparisons existed with clinical examination. The quality of studies evaluating diagnostic techniques for the detection of PAD in individuals with diabetes is poor. Improved compliance with guidelines for methodological quality is needed in future studies., (Copyright © 2015 John Wiley & Sons, Ltd.)

With the increased number of diabetics worldwide and the increased incidence of morbid obesity in more prosperous cultures, there has become an increased awareness of Charcot arthropathy of the foot and ankle. Outcome studies would suggest that patients with deformity associated with Charcot Foot arthropathy have impaired health related quality of life. This awareness has led reconstructive-minded foot and ankle surgeons to develop surgical strategies to treat these acquired deformities. This article outlines the current clinical approach to this disabling medical condition., (Copyright © 2016 John Wiley & Sons, Ltd.)