Search

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.

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.

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.

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.

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.

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.

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.

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: 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.

General principles of treatment in patients, suffering diabetic foot syndrome, are adduced. There was proved, that reconvalescence of the patients depends not only on quality of complex treatment, but from optimal choice of anesthesia method, its impact on postoperative period course. Application of prolonged blockade of n. ischiadicus gives possibility to perform operative intervention on the lower extremity in full volume, guarantees sufficient motor and sensory block, permits patients to reject from application of narcotic analgetics, to reduce the dose of strong nonnarcotic analgetics, the terms of transition of the wound process phase I into phase II, promotes early activization of patients postoperatively, constitutes alternative for other methods of anesthesiological support.

Complex service for treatment for patients, suffering diabetic foot syndrome, was created on the base of Dnipropetrovskiy Regional Clinical Hospital with the objective for application of high technologies. Creation of such a service have permitted to improve the results of the patients treatment. Enhancement of the performance rate of small operations on the foot have permitted to increase by 34.4% the quantity of patients, in whom a supportive function of the foot was preserved, and to reduce the conduction rate of the lower extremity amputation on a hip level, preserving a knee joint, by 39.5%, what is very important for the prosthesis. Widespread propaganda among population and primary link of the health service permit to reveal and eliminate complications of diabetes mellitus on earlier stages.

Objective: Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention., Research Design and Methods: As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence., Results: A total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98-27.57]), day-to-day variation in stride count (0.93 [0.89-0.99]), and cumulative duration of past foot ulcers (1.03 [1.00-1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01-23.96]), in-shoe peak pressure <200 kPa with footwear adherence >80% (0.43 [0.20-0.94]), barefoot peak pressure (1.11 [1.00-1.22]), and day-to-day variation in stride count (0.91 [0.86-0.96])., Conclusions: The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention., (© 2014 by the American Diabetes Association.)

Orthotic insoles are commonly used in the treatment of the diabetic foot to prevent ulcerations. Choosing suitable insole material is vital for effective foot orthotic treatment. We examined seven types of orthotic materials. In consideration of the key requirements and end uses of orthotic insoles for the diabetic foot, including accommodation, cushioning, and control, we developed test methods for examining important physical properties, such as force reduction and compression properties, insole-skin friction, and shear properties, as well as thermal comfort properties of fabrication materials. A novel performance index that combines various material test results together was also proposed to quantify the overall performance of the insole materials. The investigation confirms that the insole-sock interface has a lower coefficient of friction and shearing stress than those of the insole-skin interface. It is also revealed that material brand and the corresponding density and cell volume, as well as thickness, are closely associated with the performance of moisture absorption and thermal comfort. On the basis of the proposed performance index, practitioners can better understand the properties and performance of various insole materials, thus prescribing suitable orthotic insoles for patients with diabetic foot.

Objective: Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence., Research Design and Methods: We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken., Results: On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045)., Conclusions: Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

Diabetic foot ulcers (DFUs) are a chronic, non-healing complication of diabetes that lead to high hospital costs and, in extreme cases, to amputation. Diabetic neuropathy, peripheral vascular disease, abnormal cellular and cytokine/chemokine activity are among the main factors that hinder diabetic wound repair. DFUs represent a current and important challenge in the development of novel and efficient wound dressings. In general, an ideal wound dressing should provide a moist wound environment, offer protection from secondary infections, remove wound exudate and promote tissue regeneration. However, no existing dressing fulfills all the requirements associated with DFU treatment and the choice of the correct dressing depends on the wound type and stage, injury extension, patient condition and the tissues involved. Currently, there are different types of commercially available wound dressings that can be used for DFU treatment which differ on their application modes, materials, shape and on the methods employed for production. Dressing materials can include natural, modified and synthetic polymers, as well as their mixtures or combinations, processed in the form of films, foams, hydrocolloids and hydrogels. Moreover, wound dressings may be employed as medicated systems, through the delivery of healing enhancers and therapeutic substances (drugs, growth factors, peptides, stem cells and/or other bioactive substances). This work reviews the state of the art and the most recent advances in the development of wound dressings for DFU treatment. Special emphasis is given to systems employing new polymeric biomaterials, and to the latest and innovative therapeutic strategies and delivery approaches., (Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.)

To systematically assess published reports on the efficacy of electrophysical therapy in the treatment of diabetic foot ulcers, including electrical stimulation, low-level laser therapy, therapeutic ultrasound and electromagnetic therapy. Databases searched included MEDLINE, CINAHL, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) from 1966 to 2011. Studies reviewed included only randomised controlled trials (RCTs) on treatment with electrophysical modalities compared with sham, conventional treatment or other electrophysical modalities. Information extracted were objective measures of healing and data useful for the calculation of effect size. Eight RCTs were eventually included in the critical appraisal, with a combined total of 325 participants. Five studies were conducted on electrical stimulation, two on phototherapy and one on ultrasound. All studies reported that the experimental group was significantly more favourable than the control or sham group. The pooled estimate of the number of healed ulcers of the three studies on electrical stimulation compared to the control or sham electrical stimulation showed statistical significance [mean difference of 2·8 (95% CI = 1·5-5·5, P = 0·002] in favour of electrical stimulation. The results indicated potential benefit of using electrophysical therapy for managing diabetic foot ulcers. However, due to the small number of trials ever conducted, the possibility of any harmful effects cannot be ruled out, and high-quality trials with larger sample sizes are warranted., (© 2012 The Authors. International Wound Journal © 2012 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Background: Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an effective physical therapy treatment for recovering musculoskeletal function and foot rollover during gait that could potentially redistribute plantar pressure and reduce the risk of ulcer formation., Methods/design: A randomised, controlled trial, with blind assessment, was designed to study the effect of a physiotherapy intervention on foot rollover during gait, range of motion, muscle strength and function of the foot and ankle, and balance confidence. The main outcome is plantar pressure during foot rollover, and the secondary outcomes are kinetic and kinematic parameters of gait, neuropathy signs and symptoms, foot and ankle range of motion and function, muscle strength, and balance confidence. The intervention is carried out for 12 weeks, twice a week, for 40-60 min each session. The follow-up period is 24 weeks from the baseline condition., Discussion: Herein, we present a more comprehensive and specific physiotherapy approach for foot and ankle function, by choosing simple tasks, focusing on recovering range of motion, strength, and functionality of the joints most impaired by diabetic polyneuropathy. In addition, this intervention aims to transfer these peripheral gains to the functional and more complex task of foot rollover during gait, in order to reduce risk of ulceration. If it shows any benefit, this protocol can be used in clinical practice and can be indicated as complementary treatment for this disease., Trial Registration: ClinicalTrials.gov Identifier: NCT01207284.

Aims/hypothesis: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients., Methods: This was a randomised controlled trial (n=71) with an intervention (n=35) and control group (n=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up., Results: The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (p<0.001) compared with the control group. Patients in the intervention group also significantly improved their balance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down., Conclusions/interpretation: Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients' physical activity levels and quality of life., Trial Registration: ClinicalTrials.gov NCT00637546, Funding: This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/

A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.

Aims/hypothesis: Walking is recommended as an adjunct therapy to diet and medication in diabetic patients, with the aim of improving physical fitness, glycaemic control and body weight reduction. Therefore we evaluated walking activity on the basis of capacity, performance and potential risk of plantar injury in the diabetic population before it can be prescribed safely., Subjects, Materials and Methods: Twenty-three subjects with diabetic neuropathy (DMPN) were compared with 23 patients with current diabetic foot ulcers, 16 patients with partial foot amputations and 22 patients with trans-tibial amputations. The capacity for walking was measured using a total heart beat index (THBI). Gait velocity and average daily strides were measured to assess the performance of walking, and its impact on weight-bearing was studied using maximum peak pressure., Results: THBI increased (p<0.01) and gait velocity and daily stride count fell (p<0.001 for both) with progression of foot complications. The maximum peak pressures over the affected foot of patients with diabetic foot ulcers (p<0.05) and partial foot amputations (p<0.01) were higher than in the group with DMPN. On the contralateral side, the diabetic foot ulcer group showed higher maximum peak pressure over the total foot (p<0.05), and patients with partial foot amputations (p<0.01) and trans-tibial amputations (p<0.05) showed higher maximum peak pressure over the heel., Conclusions/interpretation: Walking capacity and performance decrease with progression of foot complications. Although walking is recommended to improve fitness, it cannot be prescribed in isolation, considering the increased risk of plantar injury. For essential walking we therefore recommend the use of protective footwear. Walking exercise should be supplemented by partial or non-weight-bearing exercises to improve physical fitness in diabetic populations.

Background and Purpose: Although pressure-reducing interventions have been effective in the healing of neuropathic foot ulcers, these ulcers frequently recur in people with diabetes mellitus (DM). This case report illustrates how sudden changes in weight-bearing activity may have affected ulcer recurrence in a patient with DM and how the physical stress theory (PST) relates to ulcer recurrence for this patient., Case Description: The patient was a 66-year-old man with a history of DM, peripheral neuropathy, and recurrent plantar ulcers. His plantar ulcer healed after total contact casting., Outcome: Despite relatively low peak plantar pressure (9.3 N/cm(2)), the patient's ulcer recurred within 4 weeks of healing. Plantar pressure assessment and activity monitoring suggested that a rapid and sudden increase in weight-bearing activity (steps per day) contributed to cumulative plantar tissue stress that was 3.3 times higher on the day of ulcer recurrence than his average value. Although his cumulative plantar stress was high compared with his usual value, the cumulative value was similar to the amount of daily stress of individuals without a history of recurrent ulcers., Discussion: Within the context of the PST, rapid change in activity level may have an effect on cumulative stress and the risk of ulcer recurrence.

Objective: The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations., Research Design and Methods: We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing., Results: An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02)., Conclusions: Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds.

Objective: This study tests the hypothesis that Medicare beneficiaries at high risk of foot complications who are mailed a motivational brochure describing the Medicare diabetes-related therapeutic footwear benefit will increase their therapeutic footwear-related Medicare claims., Research Design and Methods: In this quasi-experimental study, a motivational brochure was mailed in the summer of 1997 to 5,872 Medicare beneficiaries in Washington, Alaska, and Idaho who were identified as being at high risk for foot-related claims on the basis of their prior Medicare claims history. Beneficiaries were identified through footwear claims made in these states-and also in three comparison states (Oregon, Montana, and Wyoming)-during the 18 months before and after the mailing. Linear regression was used to compare the number of persons making claims in the intervention states with the comparison states before, at the time of, and after the mailing., Results: Before the intervention, the number of persons making claims was increasing in the non-intervention states and decreasing in the intervention states. During the first month after the intervention mailing, the number of persons making claims remained nearly the same in non-intervention states, but increased 13 persons per month in intervention states (95% CI 3.5-11 persons/month). After the intervention, the number of persons making claims continued to increase similarly in both intervention and non-intervention states., Conclusions: Mailed motivational brochures were associated with an increase in the number of persons making therapeutic footwear claims. Randomized trials should confirm these findings.

The relationship between repetitive trauma and propensity for ulceration and ulcer healing is unknown in part because of the lack of accurate information on activity level. The Step Activity Monitor (SAM) is a newly designed accelerometer to record activity level, but its accuracy is questionable. The purpose of this study was to determine the accuracy of the SAM under varying footwear and walking surface conditions. Ten healthy subjects consented to walk over 530 m of flat ground and up and down two flights of stairs, while wearing an athletic shoe or a fiberglass total contact cast (TCC). The accelerometer, programmed for a subject's cadence and leg motion, was secured to the distal, lateral aspect of the right lower leg. Two observers using hand-held digital counters followed the subject and recorded steps taken with the right leg on all walking surfaces. With the use of a repeated measures analysis of variance (ANOVA), the SAM and hand-held digital counters similarly recorded steps taken, regardless of walking surface condition. While the SAM was highly accurate (94 to 96 percent), the percent error was greater (p = 0.007) for the stair-climbing condition with the use of the TCC because of two subjects using a step-to-gait pattern. Overall, the SAM is an accurate accelerometer that will accurately record activity level, even with the application of a TCC. However, its accuracy may vary with deviations from a normal gait pattern.

Background and Purpose: Total contact casting is effective at healing neuropathic ulcers, but patients have a high rate (30%-57%) of ulcer recurrence when they resume walking without the cast. The purposes of this case report are to describe how data from plantar pressure measurement and spiral x-ray computed tomography (SXCT) were used to help manage a patient with recurrent plantar ulcers and to discuss potential future benefits of this technology., Case Description: The patient was a 62-year-old man with type 1 diabetes mellitus (DM) of 34 years' duration, peripheral neuropathy, and a recurrent plantar ulcer. Although total contact casting or relieving weight bearing with crutches apparently allowed the ulcer to heal, the ulcer recurred 3 times in an 18-month period. Spiral x-ray computed tomography and simultaneous pressure measurement were conducted to better understand the mechanism of his ulceration., Outcomes: The patient had a severe bony deformity that coincided with the location of highest plantar pressures (886 kPa). The results of the SXCT and pressure measurement convinced the patient to wear his prescribed footwear always, even when getting up in the middle of the night. The ulcer healed in 6 weeks, and the patient resumed his work, which required standing and walking for 8 to 10 hours a day., Discussion: Following intervention, the patient's recurrent ulcer healed and remained healed for several months. Future benefits of these methods may include the ability to define how structural changes of the foot relate to increased plantar pressures and to help design and fabricate optimal orthoses.

Objectives: To assess the efficacy of the patellar tendon bearing orthosis (PTBO) as adjunctive treatment of patients with significant lower-limb ischaemia and tissue loss complicated by neuropathy., Design, Materials and Methods: Twelve consecutive patients (14 legs) with a variety of underlying conditions causing extensive lower limb tissue loss are described. Seven patients were diabetic. Six patients (seven legs) underwent vascular reconstruction procedures., Chief Outcome Measures: Wound healing and amputation rate., Results: Eight patients had ulcer healing within 5 months, one at 18 months (patient with alcoholic neuropathy who was poorly compliant with treatment), one stopped using the PTBO at 3 months and was converted to protective footwear with healing, one died of a myocardial infarct 1 month after the PTBO was fitted (the ulcer was showing signs of healing), and one has just had surgery and been fitted with a PTBO., Conclusions: Early results from this anecdotal series are encouraging and a prospective study to determine the application of the PTBO in patients with neuropathic and neuropathic/ischaemic tissue loss is planned.

The purpose of this article is to describe the progression of ulcer healing using total contact casts (TCC) and to examine explanatory variables that may influence ulcer healing. We prospectively studied 25 diabetics with grade I (Meggitt-Wagner) plantar ulcers. All subjects received weekly contact cast changes with wound assessment. Following healing, all subjects were fitted with prescription shoe gear. Mean duration of casting until healing was 38.8 +/- 21.3 days. Individuals with pressures over 99 N/cm2 took longer to heal (33.1 +/- 13.0 vs. 53.4 +/- 31.4 days, P = 0.05) and had longer ulcer duration prior to treatment (52.7 +/- 37.2 vs. 180.7 +/- 145.0 days, P = 0.02). Subjects with wound size greater than 8 cm2 took longer to heal (50.2 +/- 26.2 vs. 29.9 +/- 10.6 days, P = 0.02). We conclude that subjects with high plantar pressures and wounds greater than 8 cm2 took significantly longer to heal when uniformly treated with TCC.

Clinical epidemiology studies suggest the majority of lower limb amputations were preceded by a minor traumatic event, often footwear-related, and lower limb ulcers. To reduce foot trauma and ulcers, the diabetic patient with foot insensitivity has unique footwear needs. To address these needs for patients not requiring custom shoes, the DVA/Seattle Footwear System was developed. The six components of this system include: 1) a specially designed shoe last based on the geometry of the diabetic foot and research findings on foot regions at highest risk of ulceration, 2) a depth-inlay shoe, "Custom Stride by PRS," designed to be paired with either a custom-fabricated cork insole or a preformed polyurethane insole, 3) a laser digitizing system that captures 3-D plantar foot contours, 4) DVA/Seattle ShapeMaker software adaptation for modifying plantar surface contours and applying free-form and template modifications to increase or relieve loading, 5) software that translates files into code used by a milling machine to define the cutting path and carve cork blockers into custom insoles, and 6) a preformed polyurethane insole thicker than a typical insole to accommodate the extra volume and the interior dimensions of the shoe. A 6-month pilot cross-over trial of 24 diabetic male veterans without prior foot ulcers was conducted to determine the feasibility of producing, and the safety of wearing, these depthinlay shoes and both types of insoles. During the first 4 weeks, patients were assigned to the study shoes and one type of insole. During the next 4 weeks, they wore the other type of insole, and during the final 4 months, they chose which pair of insoles to wear with the study shoes. Over 150 person-months of footwear observation revealed no breaks in the cutaneous barrier with use of either cork or polyurethane insoles and the study shoes. Patient compliance with the footwear was 88%. Patients were highly satisfied with the appearance, stability, and comfort of the shoes and the comfort of both types of insole. However, 75% of the patients noted that the study shoes felt heavier than their customary shoes. Further research is needed to determine the long-term effectiveness of footwear in prevention of foot ulcers in the population at highest risk for diabetic reulceration and amputation.