The Stress of Measuring Plantar Tissue Stress in People with Diabetes-Related Foot Ulcers: Biomechanical and Feasibility Findings from Two Prospective Cohort Studies.

Reducing high mechanical stress is imperative to heal diabetes-related foot ulcers. We explored the association of cumulative plantar tissue stress (CPTS) and plantar foot ulcer healing, and the feasibility of measuring CPTS, in two prospective cohort studies (Australia (AU) and The Netherlands (NL)). Both studies used multiple sensors to measure factors to determine CPTS: plantar pressures, weight-bearing activities, and adherence to offloading treatments, with thermal stress response also measured to estimate shear stress in the AU-study. The primary outcome was ulcer healing at 12 weeks. Twenty-five participants were recruited: 13 in the AU-study and 12 in the NL-study. CPTS data were complete for five participants (38%) at baseline and one (8%) during follow-up in the AU-study, and one (8%) at baseline and zero (0%) during follow-up in the NL-study. Reasons for low completion at baseline were technical issues (AU-study: 31%, NL-study: 50%), non-adherent participants (15% and 8%) or combinations (15% and 33%); and at follow-up refusal of participants (62% and 25%). These underpowered findings showed that CPTS was non-significantly lower in people who healed compared with non-healed people (457 [117; 727], 679 [312; 1327] MPa·s/day). Current feasibility of CPTS seems low, given technical challenges and non-adherence, which may reflect the burden of treating diabetes-related foot ulcers.

Cost-effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial.

AIMS: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness. Our aim was to evaluate the cost-effectiveness of at-home skin temperature monitoring to help prevent diabetes-related foot ulcer recurrence. MATERIALS AND METHODS: Multicenter randomized controlled trial. We randomized 304 persons at high diabetes-related foot ulcer risk to either usual foot care plus daily at-home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost-effectiveness based on foot care costs and quality-adjusted life years (QALY) during 18 months follow-up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost-effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness-to-pay/accept levels up to €100,000. RESULTS: The intervention had a 45% probability of being cost-effective at a willingness-to-accept of €50,000 per QALY lost. This resulted from (non-significantly) lower foot care costs in the intervention group (€6067 vs. €7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non-significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). CONCLUSIONS: At-home skin temperature monitoring for diabetes-related foot ulcer prevention compared with usual care is at best equally cost-effective. The intervention resulted in cost-savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self-monitoring burdens.

The unique multidisciplinarity of diabetes-related foot disease.

Few diseases globally require treatment from so many different disciplines as diabetes-related foot disease. At least 25 different professionals may be involved: casting technicians, dermatologists, diabetes (educator) nurses, diabetologists, dieticians, endocrinologists, general practitioners, human movement scientists, infectious diseases experts, microbiologists, nuclear medicine physicians, orthopaedic surgeons, orthotists, pedorthists, physical therapists, plastic surgeons, podiatric surgeons, podiatrists, prosthetists, psychologists, radiologists, social workers, tissue viability physicians, vascular surgeons, and wound care nurses. A shared vocabulary and shared treatment goals and recommendations are then essential. The International Working Group on the Diabetic Foot (IWGDF) has produced guidelines and supporting documents to stimulate and support shared and multidisciplinary evidence-based treatment in diabetes-related foot disease. In this special virtual issue of Diabetes/Metabolism Research and Reviews, all 21 documents of the 2023 update of the IWGDF Guidelines are bundled, added with a further 6 reviews from multidisciplinary experts to drive future research and clinical innovations, based on their contributions to the International Symposium on the Diabetic Foot. We hope the readers will enjoy this special virtual issue, and widely implement the knowledge shared here in their daily clinical practice and research endeavours with the goal to improve the care for people with diabetes-related foot disease.

Podcast on the IWGDF 2023 Guidelines on the Prevention of Foot Ulcers in Persons with Diabetes.

In this podcast, we discuss the 2023 update of the International Working Group on the Diabetic Foot (IWGDF) Guidelines on the prevention of foot ulcers in people with diabetes. Prevention of foot ulcers is paramount, to reduce their large burden on patients and society. Nevertheless, many clinical guidelines do not cover prevention as a topic. The IWGDF Guidelines ensure that a full chapter is dedicated to ulcer prevention. In that chapter, the key cornerstones of prevention are outlined, as well as the importance of integrated preventative foot care. With this podcast, we aim to highlight the importance of ulcer prevention and the opportunities to incorporate recommendations into clinical practice. This hopefully stimulates clinicians and researchers to increase focus on ulcer prevention in diabetic foot disease.A podcast audio is available with this article.

New biomechanical models for cumulative plantar tissue stress assessment in people with diabetes at high risk of foot ulceration.

To better understand stress-related foot ulceration in diabetes, the cumulative plantar tissue stress (CPTS) should be quantified accurately, but also feasibly for clinical use. We developed multiple CPTS models with varying complexity and investigated their agreement with the most comprehensive reference model available. We assessed 52 participants with diabetes and high foot ulcer risk for barefoot and in-shoe plantar pressures during overground walking at different speeds, standing, sit-to-stand transitions, and stair walking. Level of these weight-bearing activities along with footwear adherence were objectively measured over seven days. The reference CPTS-model included the pressure-time integrals of each walking stride (barefoot and shod), specified for speed; standing period (barefoot and shod); transition and stair walking stride. We compared four CPTS-models with increasing number of input parameters (models 1-4) with the reference model, using repeated measures ANOVA, Pearson's correlation and Bland-Altman plots. For the clinically-relevant metatarsal 1 region, calculated CPTS was lower for the four CPTS-models compared to reference (Δ770, Δ466, Δ24 and Δ12 MPa.s/day, respectively). CPTS associated moderately with the reference model for model 1 (r = 0.551) and very strongly for models 2-4 (r ≥ 0.937). Limits of agreement were large for models 1 and 2 (-728;2269 and -302;1233 MPa.s/day), and small for models 3 and 4 (-43;92 and -54;78 MPa.s/day). CPTS in models 3 and 4 best agreed with the reference model, where model 3 required fewer parameters, i.e., pressure-time integrals of each walking stride and standing period while barefoot and shod. These parameters need to be included for accurate and feasible CPTS assessment.

A new declaration for feet's sake: Halving the global diabetic foot disease burden from 2% to 1% with next generation care.

The 1989 Saint Vincent Declaration established a goal of halving global diabetes-related amputation rates. A generation later, this goal has been achieved for major but not minor amputations. However, diabetic foot disease (DFD) is not only a leading cause of global amputation but also of hospitalisation, poor quality of life (QoL) and disability burdens. In this paper, we review latest estimates on the global disease burden of DFD and the next generation care of DFD that could reduce this burden. We found DFD causes 2% of the global disease burden. This makes DFD the 13th largest of 350+ leading conditions causing the global disease burden, and much larger than dementia, breast cancer and type 1 diabetes. Neuropathy without ulcers and amputations makes up the largest portion of the global DFD burden yet receives the least DFD focus. Future care focussed on improving safe physical activity in people with DFD could considerably reduce the DFD burden, as this incorporates increasing physical fitness and QoL, while simultaneously decreasing ulceration and other risks. Charcot neuro-osteoarthropathy is more prevalent than previously thought. Most cases respond well to non-removable offloading devices, but surgical intervention may further reduce the considerable burden of these neuropathic fracture dislocations. Ischaemia is becoming more common and complex. Most cases respond well to revascularisation interventions, but novel revascularisation techniques, medical management and autologous cell therapies may hold the key to more cases responding in the future. We conclude that DFD causes a global disease burden larger than most conditions and existing guideline-based care and next generation treatments can reduce this burden. We suggest the World Health Organization and International Diabetes Federation declare a new goal: halving the global DFD burden from 2% to 1% within the next generation.

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis.

AIMS: Prevention of foot ulcers in persons with diabetes is important to help reduce the substantial burden on both individual and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review and meta-analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at risk thereof. MATERIALS AND METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on preventative interventions. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed risk of bias of controlled studies and extracted data. A meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was done when >1 RCT was available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: From the 19,349 records screened, 40 controlled studies (of which 33 were Randomised Controlled Trials [RCTs]) and 103 non-controlled studies were included. We found moderate certainty evidence that temperature monitoring (5 RCTs; risk ratio [RR]: 0.51; 95% CI: 0.31-0.84) and pressure-optimised therapeutic footwear or insoles (2 RCTs; RR: 0.62; 95% CI: 0.26-1.47) likely reduce the risk of plantar foot ulcer recurrence in people with diabetes at high risk. Further, we found low certainty evidence that structured education (5 RCTs; RR: 0.66; 95% CI: 0.37-1.19), therapeutic footwear (3 RCTs; RR: 0.53; 95% CI: 0.24-1.17), flexor tenotomy (1 RCT, 7 non-controlled studies, no meta-analysis), and integrated care (3 RCTs; RR: 0.78; 95% CI: 0.58-1.06) may reduce the risk of foot ulceration in people with diabetes at risk for foot ulceration. CONCLUSIONS: Various interventions for persons with diabetes at risk for foot ulceration with evidence of effectiveness are available, including temperature monitoring (pressure-optimised) therapeutic footwear, structured education, flexor tenotomy, and integrated foot care. With hardly any new intervention studies published in recent years, more effort to produce high-quality RCTs is urgently needed to further improve the evidence base. This is especially relevant for educational and psychological interventions, for integrated care approaches for persons at high risk of ulceration, and for interventions specifically targeting persons at low-to-moderate risk of ulceration.

Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update).

Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease based on the seven IWGDF Guidelines. We also describe the organisational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.

Clinical and biomechanical effectiveness of foot-ankle exercise programs and weight-bearing activity in people with diabetes and neuropathy: A systematic review and meta-analysis.

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

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update).

AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals. MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability. RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration. CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.

Definitions and criteria for diabetes-related foot disease (IWGDF 2023 update).

Multiple disciplines are involved in the management of diabetes-related foot disease and a common vocabulary is essential for clear communication. Based on the systematic reviews of the literature that form the basis of the International Working Group on the Diabetic Foot (IWGDF) Guidelines, the IWGDF has developed a set of definitions and criteria for diabetes-related foot disease. This document describes the 2023 update of these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research, to facilitate clear communication with people with diabetes-related foot disease and between professionals around the world.

Standards for the development and methodology of the 2023 IWGDF guidelines.

AIMS: Diabetes-related foot disease is a major source of patient burden and societal costs. Investing in evidence-based international guidelines on diabetes-related foot disease is important to reduce this burden and costs, provided the guidelines are focused on outcomes important to key stakeholders and are evidence-based and properly implemented. MATERIALS AND METHODS: The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2023 updates were made using the Grading of Recommendations Assessment Development and Evaluation evidence-to-decision framework. This concerns formulating relevant clinical questions and important outcomes, conducting systematic reviews of the literature and meta-analyses where appropriate, completing summary of judgement tables, and writing recommendations that are specific, unambiguous and actionable, along with their transparent rationale. RESULTS: We herein describe the development of the 2023 IWGDF Guidelines on the prevention and management of diabetes-related foot disease, which consists of seven chapters, each prepared by a separate working group of international experts. These chapters provide guidelines related to diabetes-related foot disease on prevention; classification of diabetes-related foot ulcer, offloading, peripheral artery disease, infection, wound healing interventions, and active Charcot neuro-osteoarthropathy. Based on these seven guidelines, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. CONCLUSIONS: We believe that the adoption and implementation of the 2023 IWGDF guidelines by healthcare providers, public health agencies, and policymakers will improve the prevention and management of diabetes-related foot disease, and subsequently reduce the worldwide patient and societal burden caused by this disease.

The International Working Group on the Diabetic Foot: Stories and Numbers Behind Three Decades of Evidence-Based Guidelines for the Management of Diabetes-Related Foot Disease.

Foot disease is a devastating complication of diabetes. For almost 3 decades, the mission of the International Working Group on the Diabetic Foot (IWGDF) is to produce evidence-based guidelines to inform health care providers worldwide on strategies for the prevention and management of diabetes-related foot disease. In this publication, we aim to better inform the reader about 'the story behind' the IWGDF Guidelines and thus facilitate improved uptake of the recommendations described in the guidelines. The first IWGDF Guidelines were published in 1999, and these have been successfully updated every 4 years since. With each update, IWGDF has improved the methodological rigour and extended the topics covered. This has been possible thanks to the involvement of > 100 experts from > 60 countries, all voluntarily dedicating their time. We estimate that the 2023 update of the IWGDF Guidelines required a total 10 years of full-time work, which would have cost 2 million euros if the voluntary work had been financially compensated. The IWGDF Guidelines are not only published in English but also translated to support local implementation. Currently available translations serve 2.9 billion people globally in their native language. As an independent and multidisciplinary organisation, IWGDF hopes that the 2023 update will continue to stimulate clinicians from all different disciplines to deliver the best care possible for these patients, will motivate researchers to undertake the high-quality trials needed to deliver the new evidence to advance the field further, and collectively will support people with diabetes-related foot disease to minimize their disease burdens.

An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes. METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively. DISCUSSION: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.

BACKGROUND: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. METHODS: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. RESULTS: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), "satisfaction with my wear of orthopaedic footwear" was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. CONCLUSIONS: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. TRIAL REGISTRATION: Netherlands Trial Register NL7710. Registered: 6 May 2019.

In-shoe plantar pressure depends on walking speed and type of weight-bearing activity in people with diabetes at high risk of foot ulceration.

BACKGROUND: In evaluating therapeutic footwear, in-shoe plantar pressure is usually obtained during mid-gait steps at self-selected walking speed in a laboratory setting. However, this may not accurately represent plantar pressures or indicate the cumulative stress experienced in daily life. We investigated the effects of walking speed and different weight-bearing activities on in-shoe plantar pressure in people with diabetes at high risk of ulceration. METHODS: In a cross-sectional study including 30 participants we compared in-shoe plantar pressures between three standardized walking speeds (0.8, 0.6 and 0.4 m/s) and between walking at self-selected speed and eight other weight-bearing activities (3 components of the Timed Up and Go test, accelerating, decelerating, stair ascending and descending, and standing). Mean forefoot regional peak plantar pressure and pressure-time integral were statistically assessed per foot using linear mixed models (α < 0.05) with Holm-Bonferroni correction. FINDINGS: With increasing walking speed, peak pressures increased and pressure-time integrals decreased (P ≤ 0.014). Peak pressures during standing, decelerating, stair ascending and Timed Up and Go test were lower (P ≤ 0.001), and with other activities not different to walking at self-selected speed. Pressure-time integrals during stair ascending and descending were higher (P ≤ 0.001), during standing lower (P ≤ 0.009), and with other activities not different to walking at self-selected speed. INTERPRETATION: In-shoe plantar pressure depends on walking speed and type of weight-bearing activity. Only measuring pressures to evaluate footwear at self-selected walking speed in a laboratory setting may not accurately represent the stress on the foot in daily life of the high-risk patient; a more comprehensive assessment is suggested.

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

Adherence to using offloading treatment is crucial to healing diabetes-related foot ulcers (DFUs). Offloading adherence is recommended to be measured using objective monitors. However, self-reported adherence is commonly used and has unknown validity and reliability. This study aimed to assess the validity and reliability of self-reported adherence to using removable cast walker (RCW) offloading treatment among people with DFUs. Fifty-three participants with DFUs using RCWs were included. Each participant self-reported their percentage adherence to using their RCW of total daily steps. Participants also had adherence objectively measured using dual activity monitors. After one week, a subset of 19 participants again self-reported their percentage adherence to investigate test-retest reliability. Validity was tested using Pearson's r and Bland-Altman tests, and reliability using Cohen's kappa. Median (IQR) self-reported adherence was greater than objectively measured adherence (90% (60-100) vs. 35% (19-47), p < 0.01). There was fair agreement (r = 0.46; p < 0.01) and large 95% limits of agreement with significant proportional bias (ß = 0.46, p < 0.01) for validity, and minimal agreement for test-retest reliability (K = 0.36; p < 0.01). The validity and reliability of self-reported offloading adherence in people with DFU are fair at best. People with DFU significantly overestimate their offloading adherence. Clinicians and researchers should instead use objective adherence measures.

Fragile Feet and Trivial Trauma: Communicating the Etiology of Diabetic Foot Ulcers to Patients.

People at risk for diabetic foot ulcer (DFU) often misunderstand why foot ulcers develop and what self-care strategies may help prevent them. The etiology of DFU is complex and difficult to communicate to patients, which may hinder effective self-care. Thus, we propose a simplified model of DFU etiology and prevention to aid communication with patients. The Fragile Feet & Trivial Trauma model focuses on two broad sets of risk factors: predisposing and precipitating. Predisposing risk factors (eg, neuropathy, angiopathy, and foot deformity) are usually lifelong and result in "fragile feet." Precipitating risk factors are usually different forms of everyday trauma (eg, mechanical, thermal, and chemical) and can be summarized as "trivial trauma." We suggest that the clinician consider discussing this model with their patient in three steps: 1) explain how a patient's specific predisposing risk factors result in fragile feet for the rest of life, 2) explain how specific risk factors in a patient's environment can be the trivial trauma that triggers development of a DFU, and 3) discuss and agree on with the patient measures to reduce the fragility of the feet (eg, vascular surgery) and prevent trivial trauma (eg, wear therapeutic footwear). By this, the model supports the communication of two essential messages: that patients may have a lifelong risk of ulceration but that there are health-care interventions and self-care practices that can reduce these risks. The Fragile Feet & Trivial Trauma model is a promising tool for aiding communication of foot ulcer etiology to patients. Future studies should investigate whether using the model results in improved patient understanding and self-care and, in turn, contributes to lower ulceration rates.

Self-Monitoring Diabetes-Related Foot Ulcers with the MyFootCare App: A Mixed Methods Study.

People with diabetes-related foot ulcers (DFUs) need to perform self-care consistently over many months to promote healing and to mitigate risks of hospitalisation and amputation. However, during that time, improvement in their DFU can be hard to detect. Hence, there is a need for an accessible method to self-monitor DFUs at home. We developed a new mobile phone app, "MyFootCare", to self-monitor DFU healing progression from photos of the foot. The aim of this study is to evaluate the engagement and perceived value of MyFootCare for people with a plantar DFU over 3 months' duration. Data are collected through app log data and semi-structured interviews (weeks 0, 3, and 12) and analysed through descriptive statistics and thematic analysis. Ten out of 12 participants perceive MyFootCare as valuable to monitor progress and to reflect on events that affected self-care, and seven participants see it as potentially valuable to enhance consultations. Three app engagement patterns emerge: continuous, temporary, and failed engagement. These patterns highlight enablers for self-monitoring (such as having MyFootCare installed on the participant's phone) and barriers (such as usability issues and lack of healing progress). We conclude that while many people with DFUs perceive app-based self-monitoring as valuable, actual engagement can be achieved for some but not for all people because of various facilitators and barriers. Further research should target improving usability, accuracy and sharing with healthcare professionals and test clinical outcomes when using the app.

Adherence and Wearing Time of Prescribed Footwear among People at Risk of Diabetes-Related Foot Ulcers: Which Measure to Use?

Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman's correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96-1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89-0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67-0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used.