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Background: The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease., Objectives: To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability., Methods: The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed., Results: A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862-0.998. External validity correlation levels ranged from r=0.386 to r=0.888., Conclusion: DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings., Competing Interests: Declaration of Competing Interest All authors declare that they have no conflict of interests., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: The objective of this study was to carry out the cross-cultural adaptation and validation of the Diabetic Foot Self-Care Questionnaire into the English language, broadening the applicability of this patient-reported outcome measure and improving the monitoring of patients with diabetic foot disease., Methods: The validation study into English was conducted in two phases: cross-cultural adaptation and psychometric validation study. Short Form-12 Version 2, EuroQoL-5D and Foot Function Index were used to analyze the criterion validity. Item response, internal consistency, standard error of measurement, minimal detectable change and construct validity were calculated in the validation phase., Results: An English version of the questionnaire (DFSQ-UMA-En) was successfully obtained. A total of n  = 193 participants were tested to confirm the validity and reliability of the questionnaire. Internal consistency values ranged from very good to excellent (Cronbach's α =0.889-0.981), and reliability was excellent (ICC = 0.854-0.959). Standard error measurement value was =2.543. Criterion validity ranged from r  = 0.429 to r  = 0.844. For construct validity, Kaiser-Meyer-Olkin test was =0.752., Conclusion: DFSQ-UMA-En is a valid and reliable tool with good readability and comprehension features. This questionnaire addresses foot self-care behaviors in patients with diabetic foot disease, standing out as essential for early diagnosis and prevention strategies in clinical and research settings., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ruiz-Muñoz, Fernández-Torres, Formosa, Gatt, Gijón-Noguerón, Navarro-Flores and González-Sánchez.)

Introduction: Optimising the cushioning stiffness of diabetic footwear/orthoses can significantly enhance their offloading capacity. This study explores whether optimum cushioning stiffness can be predicted using simple demographic and anthropometric parameters., Methods: Sixty-nine adults with diabetes and loss of protective sensation in their feet were recruited for this cross-sectional observational study. In-shoe plantar pressure was measured using Pedar® for a neutral diabetic shoe (baseline) and after adding cushioning footbeds of varying stiffness. The cushioning stiffness that achieved maximum offloading was identified for each participant. The link between optimum cushioning stiffness and plantar loading or demographic/anthropometric parameters was assessed using multinomial regression., Results: People with higher baseline plantar loading required stiffer cushioning materials for maximum offloading. Using sex, age, weight, height, and shoe-size as covariates correctly predicted the cushioning stiffness that minimised peak pressure across the entire foot, or specifically in the metatarsal heads, midfoot and heel regions in 70%, 72%, 83% and 66% of participants respectively., Conclusions: Increased plantar loading is associated with the need for stiffer cushioning materials for maximum offloading. Patient-specific optimum cushioning stiffness can be predicted using five simple demographic/anthropometric parameters. These results open the way for methods to optimise cushioning stiffness as part of clinical practice., 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 © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: To perform laboratory static validation of pressures from an innovative, single-sensor pressure and temperature monitoring device for the early detection of complications in the high-risk foot., Research Question: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature as accurately as the reference standard?, Methods: A pressure generating rig, the Tekscan™ Equilibration 'bladder calibrator', was used to produce a known force, against the gold standard, FScan™ in-shoe pressure mapping system by Tekscan™ and a newly developed prototype. The F-scan® system was used to record the pressure readings and establish a baseline for the readings recorded utilising the prototype. A total of 20 pressure values were recorded with 100 samples each., Results: Exploratory data analysis was conducted to gain insights and analyse the prototype's behaviour at different pressure points. Pre-processing and data cleaning were also performed to remove any anomalies. Support Vector Regressor with a polynomial kernel and Grid-Search algorithm was used to fit the recorded data curve. The best combination of parameters had a Mean Squared Error of 2.59 and a Root Mean Squared Error of 1.61. A simple linear equation was used to convert raw readings to pressure values., Significance: The results of this study conclude that the pressure measurements taken with the prototype are congruent to the gold standard, F-scan® in-shoe system. This confirms that the prototype is a valid device that can be used safely as a low-cost alternative to current costly commercial in-shoe pressure mapping devices., Competing Interests: Declaration of Competing Interest In this study, there were no associated financial and/or personal relationships with other people or organisations that could inappropriately influence (bias) this research., (Copyright © 2023. Published by Elsevier B.V.)

Background: Studies have shown that personal and economic reasons determine whether clinicians use diagnostic technology in their routine clinical biomechanical practice. This study aimed to identify the biomechanical management plan of local clinicians in relation to management of the diabetic high-risk foot and to investigate whether diagnostic technology is being used to determine the effectiveness of dispensed prescription orthoses in view of ulcer prevention., Methods: A mixed-methodologic approach was adopted in this study. A retrospective quantitative study was also conducted to access records of patients attending the biomechanics clinic at a local health biomechanics clinic. Outcomes of interest included the number and percentage of patients attending the biomechanics clinic, source of referral to this clinic, age and gender of patients, clinical diagnosis, management plan, and referral pathway. Following a phenomenologic approach, four experienced clinicians working in the private, primary, and tertiary health sectors were interviewed. Thematic analysis was used to analyze and interpret data., Results: Only low-risk patients living with diabetes mellitus were referred for a comprehensive biomechanical examination; the majority were referred by podiatrists. There was no record of diabetic high-risk patients being referred for a detailed biomechanical assessment within the health service. This study also confirmed that, because of the expenses and laborious work involved when using diagnostic technology to assess foot pressures, interviewed clinicians based their treatment plan and tested the efficiency of dispensed offloading devices on the basis of clinical experience and visual observation only., Conclusions: Waiting for signs of ulceration can be too late for the high-risk foot. A change in clinical practice is recommended where the integration of diagnostic technology, together with standard care, in view of ulcer prevention is warranted.

Background: Available technology to detect the 2 primary predictors of ulceration is not being used as it is deemed as costly and time-consuming. Thus, the aim of this study was to determine dynamic laboratory validation, of an innovative, single-sensor in-shoe device that can read peak pressure and temperature simultaneously., Research Question: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature of healthy participants, as accurately as the reference standard?, Methods: Five healthy adult participants were recruited. The prototype was validated against the gold standard FScan™ in-shoe system for pressures and the Flir® T630sc thermographic camera for temperatures. Participants were asked to walk at a comfortable pace on an electric treadmill for 13 min. The prototype and the FScan in-shoe sensors™ were superimposed inside the shoe of the participant, with the prototype on top, to ensure direct contact with the area of interest. Two thermographic images were captured using the Flir® T630sc thermographic camera, before and after the walk. During the trials, the participants wore 100 % cotton socks and their own sports shoes and pressures were recorded at 50 readings a second., Results: The raw readings of pressure were passed to the regressor, which returned the estimated kPa value. Several evaluations metrics were used to evaluate the performance of the modal. The prototype gave equal results to that of the gold standard, the FScan™ in-shoe system. With regards to temperature measurements, both devices gave similar readings., Significance: This innovative single-sensor, in-shoe pressure and temperature monitoring device showed similar measurements of pressure to the FScan™ system and temperature measurements were equivalent to the Flir® T630sc thermographic camera. The authors are confident that the innovative, low cost, single-sensor, in-shoe pressure and temperature monitoring device can be used as an alternative to the costly available commercial devices that measure pressure and temperature separately to detect early signs of complications in the high-risk foot., Competing Interests: Declaration of Competing Interest This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. The author confirm that it poses no conflict of interest., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Purpose: Diabetic foot disease is one of the most serious and expensive complications of diabetes. Patient-reported outcome measures (PROMs) analyse patients' perception of their disability, functionality and health. The goal of this work was to conduct a systematic review regarding the specific PROMs related to the evaluation of diabetic foot disease and to extract and analyse the values of their measurement properties., Methods: Electronic databases included were PubMed, CINAHL, Scopus, PEDro, Cochrane, SciELO and EMBASE. The search terms used were foot, diabet*, diabetic foot, questionnaire, patient-reported outcome, self-care, valid*, reliabil*. Studies whose did not satisfy the Critical Appraisals Skills Programme (CASP) Diagnostic Study Checklist were excluded. The measurement properties extracted were: Internal Consistency, Test-retest, Inter-rater and Intra-rater, Standard Error of Measurement, Minimum Detectable Measurement Difference, Content Validity, Construct Validity, Criterion Validity and Responsiveness., Results: The PROMs selected for this review were 12 questionnaires. The Diabetic foot self-care questionnaire (DFSQ-UMA) and the Questionnaire for Diabetes Related Foot Disease (Q-DFD) were the PROMs that showed the highest number of completed measurement properties., Conclusion: According to the results, it is relevant to create specific questionnaires for the evaluation of diabetic foot disease. It seems appropriate to use both DFSQ-UMA and Q-DFD when assessing patients with diabetic foot disease., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background and Aim: This single-centre study aimed to determine healing, re-ulceration, re-amputation and mortality rates at one year after toe amputations in patients with type 2 diabetes (T2DM)., Patients and Methods: Eighty-one participants with T2DM admitted for toe amputation were included. Patient characteristics, peripheral circulation and neuropathy status were recorded. Subjects were then followed every 3 months post-amputation for a year., Results: Overall, 59.3% of participants underwent further surgery (n=31 to revise the original amputation site and n=17 to amputate a new site). During 12 months, 45.7% of participants presented with a new ulcer at a different site. Mortality was 7.4%. In 12.4% of participants, the amputation site remained incompletely healed. Only 20.9% had no complications in 12 months. At 12 months, 80.2% of study cohort had a completely healed amputation site., Conclusion: In conclusion, this study highlighted high re-intervention, re-amputation and new ulceration rates. Strategies to improves these outcomes in such high-risk patients are warranted., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: In diabetic foot ulceration, a correlation between pressure and skin temperature is suspected. The aim of this systematic review is to provide a more rigorous analysis of existing literature related to the various technologies used to read and measure both in-shoe plantar pressures, and in-shoe skin temperatures simultaneously., Methods: A systematic review of the literature related to the topic was searched in database sources such as Medline OVID, Cochrane Library, PubMed, CONAHL, PROSPERO, and Elsevier. Outcome measures of interest included validity, reliability and responsiveness of in-shoe temperature and/or pressure mapping device used, and characteristics and quantity of sensors used, anatomical landmarks and statistical analysis used to interpret the data. Quality of evidence and risk of bias was evaluated using the QUADAS-2., Results: Nineteen studies were identified and included in this review. The majority of studies used a small sample size (mean n = 17) and recruited healthy participants. All studies have shown excellent validity but only a few tested for the reliability of the device. None of the studies tested for responsiveness of the device. Quality assessment results scored high risk in view of 'patient selection', 'use of reference standard' and 'applicability', and low risk in view of 'use if index test' and 'flow and timing'., Conclusions: The data outlined in this review confirms that further improvement, reliability testing and clinical validation of the developed systems is required despite the results of excellent performance in detecting changes of in-shoe skin temperature and pressure., 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 © 2021 Elsevier B.V. All rights reserved.)

Aim: To compare temperature changes following a challenge of limb elevation, in 3 forefoot angiosomes between type 2 diabetes mellitus patients with and without peripheral arterial disease (PAD)., Methods: Participans were categorized in a no PAD, mild PAD or severe PAD group. All underwent thermal imaging, then successive thermal images were taken at 1 min intervals after the lower limbs were elevated for 5 min. Thereafter, the lower limbs were lowered to the original position and imaged after 1 min. Mean temperatures of the hallux, medial and lateral forefoot were analysed by the angiosome concept., Results: Forty-two limbs were analysed. Mean resting temperatures of all angiosomes of participants with PAD were higher than those with no peripheral arterial disease. A significant difference in the mean initial temperature between the groups was found in the medial and lateral forefoot angiosomes (p=0.048, p=0.049 respectively), whilst at the hallux these temperatures were not significant (p=0.165). After limb elevation, the only significant difference was seen in the lateral foot area at 1 min (p=0.021)., Conclusions: These results confirm that patients with PAD exhibit significantly higher forefoot temperatures, according to the angiosome concept. The challenge by foot elevation did not affect the thermal pattern significantly., Competing Interests: No conflict of interest has been declared by the authors., (Thieme. All rights reserved.)

Background: The need to classify, score and describe diabetic foot ulcerations is needed for accurate clinical documentation. An agreed wound classification can improve communication between health care professionals, and improve ease of discussion regarding potential outcomes. This study aimed to determine the inter-rater reliability between four validated wound classification systems., Research Design and Method: A prospective non-experimental comparative study was conducted. Forty patients with diabetes presenting with a new or long-standing ulceration were recruited. Each ulcer was graded/scored by three clinicians using four widely used classification systems; namely the University of Texas, SINBAD, Meggitt-Wagner and the PEDIS scoring systems., Results: All classifications had a satisfactory inter-rater agreement when evaluated by three raters of various clinical experience, however, the strength of the agreement varied between classifications. The Meggitt-Wagner system had an almost perfect agreement, the SINBAD and UT systems had a strong inter-rater agreement whilst the PEDIS had a moderate inter-rater agreement., Conclusion: Results of study serve as assurance and provides the evidence that these systems may be reliably used by different clinicians, even those with varied experience in wound care., (Copyright © 2020 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.)

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: Elevated plantar pressure is considered a significant risk factor for ulceration in diabetes mellitus. The aim of this study was to determine whether duration of diabetes could affect plantar pressure in patients with no known significant comorbidity or foot pathology., Methods: Participants with type 2 diabetes, but without known confounding factors that could alter peak pressure, were matched for age, weight, and gender and categorized into 3 groups of diabetes duration: group 1 (1-5 yr), group 2 (6-10 yr), and group 3 (11-15 yr). Plantar pressures were recorded utilizing a two-step protocol at a self-selected speed., Results: One-way analysis of variance (ANOVA) revealed significant differences in mean peak plantar pressures between the three groups under the 2 nd - 4 th metatarsophalangeal joint (MPJ) region of interest (ROI) (p = 0.012 and p = 0.022, respectively) and left heel (p = 0.049). Also, a significant difference in mean pressure-time integral under the left 2 nd - 4 th MPJ ROI (p = 0.021) and right heel (p = 0.048) was observed. Regression analysis confirmed that mean peak plantar pressures in the first group (but not in the second group) were significantly lower than in the third group (p = 0.005)., Conclusions: As the duration of diabetes increased, peak plantar pressure increased significantly under the 2 nd - 4 th MPJ ROIs. These findings suggest that clinicians should make more use of pressure mapping technology as part of their clinical management plan in patients with diabetes >10 yr, even if they have no complications or deformities, to preserve functional limbs in this high-risk population.

Background: Clinicians currently rely on observational clinical data pertaining to the biomechanics of the diabetic foot. However, advances in technology can objectively describe this. A thorough understanding of the functional and mechanical consequences following trans-tibial amputations is lacking., Research Question: Does a trans-tibial prostheses significantly increase peak plantar pressures and pressure time integrals in the intact foot of patients with type-2 diabetes and neuropathy?, Methods: A prospective quantitative matched-subject design was employed. Twenty participants living with diabetes and peripheral sensory neuropathy were recruited. Ten participants presented with a trans-tibial amputation and 10 had intact feet. Participants were matched for gender, age, foot type and BMI. Peak plantar pressure and pressure time integral data were recorded using the Tekscan HR™ pressure mat system, using the two-step gait protocol. The Shapiro-Wilk test was used to determine normality of data. The Independent Samples t-test and the Mann Whitney U test were carried out to reject the null hypothesis., Results: Although no significant differences (p < 0.05) in mean peak plantar pressures were observed in all the foot masks analysed between the amputee and the control group, a significant difference (p = 0.002) in mean pressure time integrals was recorded with highest pressure time integral (PTI) values under the 2nd-4th metatarsophalangeal joint (MTP joint) for the trans-tibial amputee group., Significance: Cumulative exposure of both pressure and time can lead to tissue damage. PTI could be considered as an important contributory factor in determining ulcer formation. Elevated PTI under the 2nd-4th MTP joints sustained in the intact contralateral limb in patients using below knee prosthesis could possibly be due to gait alterations in this population. The preservation of the contralateral limb is of great concern and importance as this might impact patient's mobility and quality of life., (Copyright © 2018 Elsevier B.V. All rights reserved.)

This study aimed to determine whether thermal imaging can detect temperature differences between healthy feet, nonulcerated neuroischemic feet, and neuroischemic feet with toe ulcers in patients with type 2 diabetes mellitus (T2DM). Participants were prospectively divided into 3 groups: T2DM without foot problems; a healthy, nonulcerated neuroischemic group, and an ulcerated neuroischemic group. Thermal images of the feet were obtained with automated segmentation of regions of interest. Thermographic images from 43 neuroischemic feet, 21 healthy feet, and 12 neuroischemic feet with active ulcer in one of the toes were analyzed. There was a significant difference in toe temperatures between the 3 groups ( P = .001), that is, nonulcerated neuroischemic (n = 181; mean temperature = 27.7°C [±2.16 SD]) versus neuroischemic ulcerated (n = 12; mean temperature = 28.7°C [±3.23 SD]), and healthy T2DM group (n = 104; mean temperature = 24.9°C [±5.04 SD]). A post hoc analysis showed a significant difference in toe temperatures between neuroischemic nonulcerated and healthy T2DM groups ( P = .001), neuroischemic ulcerated and healthy groups ( P = .001). However, no significant differences in toe temperatures were identified between the ulcerated neuroischemic and nonulcerated neuroischemic groups ( P = .626). There were no significant differences between the ulcerated toes (n = 12) and the nonulcerated toes (n = 57) of the same foot in the ulcerated neuroischemic group ( P = .331). Toe temperatures were significantly higher in neuroischemic feet with or without ulceration compared with healthy feet in patients with T2DM. There were no significant differences in temperatures of ulcerated toes and the nonulcerated toes of the same foot, implying that all the toes of the same foot could potentially be at risk of developing complications, which can be potentially detected by infrared thermography.

Background: We sought to evaluate the relationship between baseline hemoglobin A 1c (HbA 1c ) level and clinical outcomes, including foot ulcer outcome (resolved versus unresolved) and wound-healing time, in individuals with type 2 diabetes., Methods: A prospective observational study was conducted on 99 patients presenting with a diabetic foot ulceration. Patient and ulcer characteristics were recorded. Patients were followed up for a maximum of 1 year., Results: After 1 year of follow-up, 77% of ulcers healed and 23% did not heal. Although this study demonstrated that the baseline HbA 1c reading was not a significant predictor of foot ulcer outcome (P = .603, resolved versus amputated), on further statistical analyses, when HbA 1c was compared with the time taken for complete ulcer healing in the resolved group (n = 77), it proved to be significant (P = .009)., Conclusions: These findings have important implications for clinical practice, especially in an outpatient setting. Improving glycemic control may improve ulcer outcomes. Prediction of outcome may be helpful for health-care professionals in individualizing and optimizing clinical assessment and management of patients. Identification of determinants of outcome could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.

Background: We sought to determine patient and ulcer characteristics that predict wound healing in patients living with diabetes., Methods: A prospective observational study was conducted on 99 patients presenting with diabetic foot ulceration. Patient and ulcer characteristics were recorded. Patients were followed up for a maximum of 1 year., Results: After 1 year of follow-up, ulcer characteristics were more predictive of ulcer healing than were patient characteristics. Seventy-seven percent of ulcers had healed and 23% had not healed. Independent predictors of nonhealing were ulcer stage (P = .003), presence of biofilm (P = .020), and ulcer depth (P = .028). Although this study demonstrated that the baseline hemoglobin A 1c reading at the start of the study was not a significant predictor of foot ulcer outcome (P = .603, resolved versus amputated), on further statistical analyses, when hemoglobin A 1c was compared with the time taken for complete ulcer healing (n = 77), it proved to be significant (P = .009)., Conclusions: The factors influencing healing are ulcer stage, presence of biofilm, and ulcer depth. These findings have important implications for clinical practice, especially in an outpatient setting. Prediction of outcome may be helpful for health-care professionals in individualizing and optimizing clinical assessment and management of patients. Identification of determinants of outcome could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.

Aim: To evaluate critically the current guidelines for foot screening in patients with diabetes, and to examine their relevance in terms of advancement in clinical practice, improvement in technology, and change in socio-cultural structure., Methods: A structured literature search was conducted in Pubmed/Medline, CINAHL, Cochrane Register of Controlled Trials, and Google between January 2011 and January 2015 using the keywords '(Diabetes) AND (Foot Screening) AND (Guidelines)'., Results: Ten complete diabetes foot screening guidelines were identified and selected for analysis. Six of them included the full-process guidelines recommended by the International Diabetes Federation. Evaluation of the existing diabetes foot screening guidelines showed substantial variability in terms of different evidence-based methods and grading systems to achieve targets, making it difficult to compare the guidelines. In some of the guidelines, it is unclear how the authors have derived the recommendations, i.e. on which study results they are based, making it difficult for the users to understand them., Conclusions: Limitations of currently available guidelines and lack of evidence on which the guidelines are based are responsible for the current gaps between guidelines, standard clinical practice, and development of complications. For the development of standard recommendations and everyday clinical practice, it will be necessary to pay more attention to both the limitations of guidelines and the underlying evidence.

Aim: To identify any significant differences in physiological test results between healing and non healing amputation sites., Methods: A single center prospective non-experimental study design was conducted on fifty subjects living with type 2 diabetes and requiring a forefoot or toe amputation. Subjects underwent non-invasive physiological testing preoperatively. These included assessment of pedal pulses, preoperative arterial spectral waveforms at the ankle, absolute toe pressures, toe-brachial pressure index and ankle-brachial pressure index. After 6 weeks, patients were examined to assess whether the amputation site was completely healed, was healing, had developed complications, or did not heal., Results: There was no significant difference in ABPI between the healed/healing and the non-healing groups. Mean TBI (p=0.031) and toe pressure readings (p=0.014) were significantly higher in the healed/healing group compared to the non healing group. A significant difference was also found in ankle spectral waveforms between the two groups (p=0.028)., Conclusions: TBIs, toe pressures and spectral waveforms at the ankle are better predictors of likelihood of healing and non-healing after minor amputation than ABPIs. ABPI alone is a poor indicator of the likelihood of healing of minor amputations and should not be relied on to determine need for revascularization procedures before minor amputation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: Several treatment modalities and protocols for arterial wound ulcers are available; however, little consensus exists on which treatment modality provides the best results. The present study sought to compare and evaluate the clinical efficacy of vacuum-assisted closure wound therapy to calcium alginate dressings in the treatment of neuroischemic diabetic foot ulceration., Material and Methods: A single-center quasi-experimental matched subject clinical trial was conducted on 30 subjects living with type 2 diabetes and presenting with a newly diagnosed neuroischemic foot ulceration. Subjects were divided into 2 groups. Group A (n = 15) underwent negative pressure wound therapy and Group B (n =15) underwent treatment using calcium alginate dressings. Ulcer area and depth were measured during the trial., Results: Both negative pressure therapy and calcium alginate dressings were effective in reducing the surface area and depth of ulcers (P = 0.0001). However, negative pressure was 3.2 times more effective in reducing surface area and 3.78 times more effective in reducing depth of ulcers when compared to calcium alginate (P = 0.0001)., Conclusion: Vacuum-assisted closure should be considered as the treatment of choice for neuroischemic ulceration owing to its advantages in reducing surface area and depth when compared to calcium alginate dressings. Improved care could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.

Aims: The main objective of this research was to identify the prevalence of diabetes-related lower-extremity complications in a cohort of Maltese patients living with type 2 diabetes., Methods: A retrospective study was conducted on a cohort of 243 patients living with type 2 diabetes mellitus in two Maltese Health Centre catchment areas. A convenience sampling was adopted to recruit subjects from a local pilot diabetes foot screening program. The clinical assessments used during this screening program were based on validated and previously published tools such as: neuropathy disability score, vibration perception threshold, Semmes-Weinstein monofilaments, vascular status and foot deformities were evaluated., Results: The results from this study demonstrate that risk factors for foot deterioration and ulceration are common in Maltese population living with type 2 diabetes. Whilst, metabolic outcomes such as hypertension and dyslipidaemia were present in most subjects, peripheral vascular disease, peripheral sensory neuropathy and foot deformities were also common. Twenty-six per cent of the sample had to be referred for further vascular assessment following this screening program due to their critical vascular status., Conclusions/interpretation: A significant proportion of Maltese participants living with type 2 diabetes presented with vascular insufficiency, abnormal neural function and deformities in the feet. Metabolic outcomes such as high blood pressure and high levels of cholesterol were also highly prevalent. Strengthening of existing screening structures is imperative in order to reduce the burden of this disease in Malta., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Elevated foot pressure and high temperatures have been proposed as predictive factors for diabetic foot ulceration; however, on their own, their predictive value is still questionable. This pilot study hypothesized that combining these two measurements in a thermo-pressure model could result in a more reliable risk assessment tool for providing risk categorization aimed to determine whether there is a correlation between foot plantar pressure and temperature in patients living with diabetes mellitus (DM) when compared with healthy individuals following a 15 min walk. Foot pressure and thermographic images were taken from 48 participants who were categorised into four groups following clinical evaluation into healthy individuals (Group A), living with DM with no complications (Group B), DM with peripheral arterial disease (Group C) and DM patients with neuropathy (Group D). This study demonstrated a positive correlation between pressure and temperature; as pressure increases, so does temperature. This was more pronounced in the groups with DM when compared to the healthy group. More research is warranted to further develop this innovative thermo-pressure model, which could hopefully be more sensitive in categorizing and identifying patients living with DM who are at risk of developing foot ulceration to initiate prompt care. [ABSTRACT FROM AUTHOR]

Background: To evaluate the effect of smoking on arterial perfusion and to determine whether smoking cessation would result in a significant improvement on the circulation of persons living with type 2 diabetes mellitus (T2DM). Methods: A nonexperimental comparative quantitative research was conducted amongst 32 participants with type 2 diabetes mellitus (T2DM) and controlled hyperlipidemia [smokers (n = 11), past smokers (n = 11), and nonsmokers (n = 10); aged ≥ 40 & ≤ 85 years]. Participants were matched for age, body mass index, estimated glomerular filtration rate, packet years, duration of diabetes mellitus, and glycated hemoglobin levels (HbA1c, %) utilizing frequency distribution matching. Peripheral arterial disease (PAD) was assessed utilizing the toe brachial pressure index (TBPI). TBPI value of ≤0.7 was suggestive of PAD while >0.7 was considered normal. Results: Sixty-four limbs were included for analyses. One-way ANOVA showed significant difference in the TBPI scores between the three categories (p < 0.05), with the current smokers demonstrating the lowest TBPI means (0.544), followed by past smokers (0.649) and nonsmokers having the highest TBPI (0.781). Tukey's post-hoc analysis confirmed significant difference in TBPI between current and nonsmokers (p = 0.024). Linear regression of risk predictors identified packet years as the best predictor (p = 0.004), followed by HbA1c (0.019). Conclusions: Results suggest that smoking has a significant effect on PAD in T2DM and that improved perfusion is found in past smokers. Empowering patients to cease smoking will result in better limb perfusion. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to compare different screening modalities in the detection of PAD in a primary care setting.Methods: Fifty participants living with Type 2 diabetes were recruited. Pulse palpation, waveform analysis, ankle brachial pressure index, absolute toe pressure, toe brachial pressure index and transcutaneous oxygen pressure were compared in the detection of peripheral arterial disease. One hundred limbs were included for analysis.Results: This study showed different results in peripheral arterial disease screening tests in the same group of participants. The highest percentage of participants who had PAD was for the Doppler Waveform (93.0%). This was followed by TBPI (72.0%), ABPI (57.0%), ATP (35.0%), TCPO (30.0%) and pulse palpation (23.0%). The difference between these percentages is significant (p<0.0005). The magnitude of the effect size is medium/moderate (Cramer's V=0.498).Conclusion: This study demonstrates that inconsistencies exist between the agreement of the 6 different modalities used to detect PAD. These findings should create an awareness amongst clinicians when interpreting results of these tests. The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which screening modalities would yield the most valid results. [ABSTRACT FROM AUTHOR]

Aim: To determine whether thermography could detect diabetes foot complications of peripheral arterial disease (PAD), neuropathy and neuroischaemia when compared with those of healthy adults. Method: Participants were categorized into five groups: healthy, healthy diabetes, PAD and neuroischaemic groups following a clinical examination. Thermography of the foot was then performed at an ambient temperature of 23oC. Results / Discussion: 43 neuroischaemic feet, 41 neuropathic feet, 58 PAD feet, 21 DM feet without complications, and 126 healthy feet were had thermographic imaging which were then analyzed. The temperatures of the feet and toes were significantly higher in the complications group when compared to the healthy adult and DM healthy groups. Results of this study show that the higher the temperatures of the foot in DM, the higher the probability that it is affected by neuropathy, neuroischaemia, or PAD (figure 1). Conclusion: There were significant differences between the temperatures of healthy feet and the feet of participants with complications. This suggests that thermography can possibly be utilized as a quick non-contact screening tool to detect patients with these complications, whereby such patients can be quickly identified by this emerging technology. This would save both clinical and human resources by avoiding having to screen all diabetes patients, thus enabling clinicians to spend more time with those patients with complications. [ABSTRACT FROM AUTHOR]

Aim: To identify any difference in mental health status and quality of life in lower limb amputees with diabetes compared to individuals without lower limb amputation. Method: A prospective, matched, non-experimental study was conducted at a diabetic foot ward. Subjects were divided into two groups. Group 1: 38 participants undergone a minor amputation and group 2: 38 participants without amputation /history of amputation. Participants were interviewed twice using two questionnaires to screen for mental health status and quality of life. These included the SRQ 20 and EQ-5D-5L. Interviews occurred one week post amputation and after 6 months. Results / Discussion: The mean SRQ 20 score for group 1 at time 0 [1 week post amputation] was that of 8.50, whilst for group 2 was that of 1.34. Since a threshold level of 8 or more suggests psychological distress, the results are indicative that group 1 showed positive presence of mental health disorder. At Time 1 the mean SRQ 20 for group 1 decreased to 5.42 indicating a decrease in psychological distress after six months. Significant differences in the mean values for each dimension of the EQ 5D 5L between group 1 and group 2 indicated that amputees had poorer quality of life than individuals without amputation at time 0 and time 1. Conclusion: Mental health and quality of life are negatively affected after minor lower limb amputation. Routine screening for depression is recommended. Mental health matters MUST NOT be relegated to the bottom of priorities in national health systems. [ABSTRACT FROM AUTHOR]

To investigate the relationship between diabetes-related knowledge and foot ulceration among people with type 2 diabetes, the authors assessed diabetes knowledge in groups with and without foot ulceration. There was no significant difference in diabetes-related knowledge between the two groups, although the mean level of knowledge in the group with foot ulceration was greater. The authors' question current approaches to diabetes education and suggest that anew approach to diabetes education programmes is needed. [ABSTRACT FROM AUTHOR]