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Background: The field of medical grade footwear is dynamic. Originally, a field where individual knowledge, expertise and skills determined the footwear and its outcomes, now becoming a more evidence‐based and data‐driven field with protocols and systems in place to create appropriate footwear. However, scientific evidence concerning medical grade footwear is still limited. Evidently, all stakeholders, from patients to pedorthists to rehabilitation physicians, will profit from a larger evidence‐base in this field. A widely supported research agenda is an essential first step to advance and facilitate new knowledge. Methods: We formed a multidisciplinary team and followed the methodology from Dutch medical societies for the development of a research agenda on medical grade footwear. This consisted of seven steps: (1) inventory of relevant questions with users and professionals; (2) analyses of responses; (3) analyses of existing knowledge and evidence; (4) formulating research questions; (5) prioritising research questions by users and professionals; (6) finalising the research agenda and (7) implementing the research agenda. Results: In phase 1, 109 participants completed a survey, including 50% pedorthists, 6% rehabilitation physicians and 3% users. Participants provided 228 potential research questions. In phases 2–4, these were condensed to 65 research questions. In phase 5, 152 participants prioritised these 65 research questions, including 50% pedorthists, 13% rehabilitation physicians and 9% users. In phase 6, the final research agenda was created, with 26 research questions, categorised based on the International Classification of Functioning Disability and Health 'process description assistive devices'. In phase 7, an implementation meeting was held with over 50 stakeholders (including users and professionals), resulting in seven applications for research projects based on one or more research questions from the research agenda. Conclusions: This research agenda structures and guides knowledge development within the field of medical grade footwear in the Netherlands and elsewhere. We expect that this will help to stimulate the field to tackle the research questions prioritised and with that to advance scientific knowledge in this field. [ABSTRACT FROM AUTHOR]

Monitoring foot skin temperatures at home have been shown to be effective at preventing the occurrence of diabetic foot ulcers. In this study, the construct validity of using >2.2°C difference between contralateral areas on the foot as a warning sign of imminent ulceration is explored. Thirty participants with diabetes at high risk of ulceration (loss of protective sensation and previous ulceration and/or amputation) monitored their foot temperatures at six sites, four times a day for six days using a handheld infrared thermometer. Walking activity, time of day, and environmental temperature were also monitored and correlated with foot temperatures. We found that contralateral mean skin temperature difference was 0.78°C at baseline. At single sites, left-to-right temperature differences exceeding the threshold were found in 9.6% of measurements (n = 365), which reduced to 0.4% when individually corrected and confirmed the next day. No correlation was found between contralateral temperature differences and activity, time of day, and environmental temperature. We conclude that using a >2.2°C difference is invalid as a single measurement in people at high risk of ulceration, but the construct validity is appropriate if both individual corrections and next day confirmation are applied. [ABSTRACT FROM AUTHOR]

Pressure-relieving footwear helps prevent foot ulcers in people with diabetes. The footwear design contributes to this effect and includes the insole top cover. We aimed to assess the offloading effect of materials commonly used as insole top cover. We measured 20 participants with diabetes and peripheral neuropathy for in-shoe peak pressures while walking in their prescribed footwear with the insole covered with eight different materials, tested in randomized order. Top covers were a 3 mm or 6 mm thick open or closed-cell foam or a 6 mm thick combination of open- and closed-cell foams. We re-assessed pressures after one month of using the top cover. Peak pressures were assessed per anatomical foot region and a region of interest (i.e., previous ulceration or high barefoot pressure). Walking comfort was assessed using a 10-point Likert scale. Mean peak pressure at the region of interest varied between 167 (SD:56) and 186 (SD:65) kPa across top covers (p < 0.001) and was significantly higher for the 3 mm thick PPT than for four of the seven 6 mm thick top covers. Across 6 mm thick top covers, only two showed a significant peak pressure difference between them. Over time, peak pressures changed non-significantly from −2.7 to +47.8 kPa across top cover conditions. Comfort ratings were 8.0 to 8.4 across top covers (p = 0.863). The 6 mm thick foams provided more pressure relief than the 3 mm thick foam during walking in high-risk people with diabetes. Between the 6 mm thick foams and over time, only small differences exist. The choice of which 6 mm thick insole top cover to use may be determined more by availability, durability, ease of use, costs, or hygienic properties than by superiority in pressure-relief capacity. [ABSTRACT FROM AUTHOR]

Introduction: Adherence to wearing prescribed footwear is paramount in reducing the risk of developing diabetes‐related foot ulcers, but adherence is often lower than optimal. This study aimed to investigate predictors of footwear adherence and variations in adherence and activity in people at risk of diabetes‐related foot ulceration. Methods: Sixty people at high foot ulcer risk were included. We measured the proportion of weight‐bearing acitivity time the prescribed footwear was worn for seven days. Multiple linear regression and analysis of variance were used. Results: Mean overall adherence was 63%. Adherence was lower at home than away from home (59% vs. 74%), while activity was higher at home (2.2 vs. 1.2 h/day). Adherence was similar across activities (61%–63%). No variable predicted the overall adherence. Higher Hba1c predicted lower adherence at home (β = −0.34, p = 0.045, R2 = 11.6%). More daily steps predicted lower adherence away from home (β = −0.30, p = 0.033, R2 = 9.3%). Adherence and activity were highest in mornings (71%, 1.1 h) and afternoons (71%, 1.5 h), and lower in evenings (40%, 0.8 h) and at nights (9%, 0.1 h). Adherence was similar on weekdays and weekend days (63% vs. 60%), but activity was higher on weekdays (3.4 vs. 3.0 h). Conclusion: Adherence levels and predictors thereof differed between adherence at home and away from home, so we suggest to treat them as different concepts. Due to the low explained variance, future studies should focus on other predictors such as psychological variables. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: Most diabetic foot ulcers are caused by tissue stress from being ambulatory in people without protective sensation. These ulcers are suggested to be preceded by local skin temperature increase due to inflammation of the underlying tissue, a so‐called hotspot. Evidence to support this mechanism of ulcer development is meagre at best. We investigated if foot ulcers are preceded by increased skin temperature in people with diabetes and foot ulcer history. Material and Methods: Participants measured temperature at 6–8 plantar foot locations each day for 18 months and identified a hotspot with a temperature difference >2.2°C between corresponding foot locations for two consecutive days. Results: Twenty‐nine of 151 participants developed a non‐traumatic ulcer while adhering to temperature measurements. In the 2 months prior to ulceration, 8 (28%) had a true hotspot (i.e. at/adjacent to the ulcer location) and the hotspot was on average no longer present 9 days before ulceration. Seven (24%) participants had a false hotspot (i.e. at another location) and 14 (48%) had no hotspot. Conclusions: The skin of the majority of the ulcers does not heat up before it breaks down or, when it does, not directly before breakdown, questioning the foot temperature increase—uslcer association. [ABSTRACT FROM AUTHOR]