Aims: Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes‐related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on offloading interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.Materials and Methods: We followed the GRADE approach by devising clinical questions and important outcomes in the PICO (Patient‐Intervention‐Control‐Outcome) format, undertaking a systematic review and meta‐analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability.Results: For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non‐removable knee‐high offloading device as the first‐choice offloading intervention. If contraindications or patient intolerance to non‐removable offloading exist, consider using a removable knee‐high or ankle‐high offloading device as the second‐choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third‐choice offloading intervention. If such a non‐surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non‐plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice.Conclusion: These offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes‐related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.

Purpose: To evaluate the validity of a modified version of the Orthotics and Prosthetics Users’ Survey (OPUS) with persons using different prosthetic and orthotic (P&O) devices.Method: Two-hundred-and-eighty-two adults using prosthesis, orthosis, shoe insoles or orthopaedic shoes completed OPUS. OPUS comprises five modules - Lower and Upper Extremity Functional Status, respectively (LEFS and UEFS), Client Satisfaction with Device and Services, respectively (CSD and CSS), and, Health-Related Quality of Life (HRQoL). Eight new items were added to LEFS and six to UEFS. Rasch analysis was used for data analyses.Results: Rating scales functioned satisfactory after some modifications. All modules demonstrated a ceiling effect. Unidimensionality was satisfactory after deleting some items and dividing HRQoL into two subscales, although somewhat weak on CSD and CSS. Item reliability was excellent for all modules and person reliability good for all but CSD and CSS. Some items demonstrated differential item functioning related to sex and age, but the impact on person measures was small.Conclusions: This study supports the validity of a modified version of OPUS for persons using different P&O devices, but also reveals limitations to be addressed in future studies. OPUS could be useful in clinical rehabilitation and research to evaluate P&O outcomes.

Background: Offloading treatment is crucial to heal diabetes‐related foot ulcers (DFU). This systematic review aimed to assess the effectiveness of offloading interventions for people with DFU.Methods: We searched PubMed, EMBASE, Cochrane databases, and trials registries for all studies relating to offloading interventions in people with DFU to address 14 clinical question comparisons. Outcomes included ulcers healed, plantar pressure, weight‐bearing activity, adherence, new lesions, falls, infections, amputations, quality of life, costs, cost‐effectiveness, balance, and sustained healing. Included controlled studies were independently assessed for risk of bias and had key data extracted. Meta‐analyses were performed when outcome data from studies could be pooled. Evidence statements were developed using the GRADE approach when outcome data existed.Results: From 19,923 studies screened, 194 eligible studies were identified (47 controlled, 147 non‐controlled), 35 meta‐analyses performed, and 128 evidence statements developed. We found non‐removable offloading devices likely increase ulcers healed compared to removable offloading devices (risk ratio [RR] 1.24, 95% CI 1.09–1.41; N = 14, n = 1083), and may increase adherence, cost‐effectiveness and decrease infections, but may increase new lesions. Removable knee‐high offloading devices may make little difference to ulcers healed compared to removable ankle‐high offloading devices (RR 1.00, 0.86–1.16; N = 6, n = 439), but may decrease plantar pressure and adherence. Any offloading device may increase ulcers healed (RR 1.39, 0.89–2.18; N = 5, n = 235) and cost‐effectiveness compared to therapeutic footwear and may decrease plantar pressure and infections. Digital flexor tenotomies with offloading devices likely increase ulcers healed (RR 2.43, 1.05–5.59; N = 1, n = 16) and sustained healing compared to devices alone, and may decrease plantar pressure and infections, but may increase new transfer lesions. Achilles tendon lengthening with offloading devices likely increase ulcers healed (RR 1.10, 0.97–1.27; N = 1, n = 64) and sustained healing compared to devices alone, but likely increase new heel ulcers.Conclusions: Non‐removable offloading devices are likely superior to all other offloading interventions to heal most plantar DFU. Digital flexor tenotomies and Achilles tendon lengthening in combination with offloading devices are likely superior for some specific plantar DFU locations. Otherwise, any offloading device is probably superior to therapeutic footwear and other non‐surgical offloading interventions to heal most plantar DFU. However, all these interventions have low‐to‐moderate certainty of evidence supporting their outcomes and more high‐quality trials are needed to improve our certainty for the effectiveness of most offloading interventions.

Introduction: Therapeutic shoes are prescribed to prevent diabetic foot ulcers, but adherence to wearing the shoes is often poor. Aim: The aim of this study was to review the literature on factors that are associated with adherence to wearing therapeutic shoes and construct a model of adherence to aid future research and development in the field. Methods: We conducted a systematic search in PubMed, CINAHL, and PsycINFO for quantitative studies on factors associated with adherence to wearing therapeutic shoes among people with diabetes. Results: Six studies were included in the review. The studies focused mainly on patient-, therapy-, and condition-related adherence factors. There is some evidence (three to five studies) that sex, diabetes duration, and ulcer history are not associated with adherence. The evidence for or against the other factors was weak (only one or two studies) or conflicting. Conclusion: There is no conclusive evidence for using any factor to predict adherence to wearing therapeutic shoes, but there is some evidence against using certain factors for predicting adherence. Future studies should include a broader range of factors, including health system and social/economic factors, and they should investigate perceived costs and benefits of wearing therapeutic shoes in comparison with other shoes or no shoes. A seesaw model is presented illustrating the complex phenomenon of adherence. Further research is needed to identify factors associated with adherence to wearing therapeutic shoes, to enable the development of interventions to improve adherence and thereby reduce ulceration rates among people with diabetic foot complications.

Physical activity is an essential part of general health and diabetes management. However, recommending weight-bearing physical activity for people with plantar diabetic foot ulcers is controversial, even when gold standard offloading devices are used, as it is commonly thought to delay healing. We aimed to narratively review relevant studies investigating the relationship between plantar diabetic foot ulcer healing and weight-bearing activity, plantar pressure and device adherence. We defined relevant studies as those from two systematic reviews, along with those identified since using a similar updated Pubmed search strategy. We identified six studies. One study found that more daily steps were associated with worse ulcer healing, three found no significant association between steps and ulcer healing, and in two others the association was unclear. Thus, there is weak evidence for an inverse relationship between weight-bearing physical activity and plantar ulcer healing while utilizing offloading devices. We propose a Diabetic foot Offloading and Activity framework to guide future research to find the optimal balance between the positive and negative effects of weight-bearing activity in the context of foot ulcers. We hope such future studies will shed more conclusive light on the impact of weight-bearing activity on healing of plantar diabetic foot ulcers.

Aims: People at increased risk of developing diabetic foot ulcers often wear therapeutic footwear less frequently than is desirable. The aims were to identify patient groups prone to nonadherence to wearing therapeutic footwear and modifiable factors associated with adherence.Materials and methods: A questionnaire was mailed to 1230 people with diabetes who had been fitted with therapeutic footwear. Independent variables were categorized into five domains. For each domain, variables that were associated with adherence in a univariate regression analysis were entered into a multiple regression analysis.Results: A total of 429 (34.9%) questionnaires were analyzed. Multiple regression analyses showed significant associations (p < 0.05) between higher adherence and paid employment, current foot ulcer, previous foot ulcer, satisfaction with follow‐up, self‐efficacy, understanding of lost/reduced sensation as a risk factor for foot ulcerations, visible storage of therapeutic footwear at home, storage of conventional footwear out of sight, consistent choices about which footwear type to wear, and a belief that therapeutic footwear promotes ulcer healing. The five multivariate models explained 2–28% of the variance in adherence, with the strategies for footwear use domain explaining the most.Conclusions: Patients without paid employment or without foot ulcer experience are more prone to nonadherence. To improve adherence, clinicians should advise patients to store therapeutic footwear in a visible place at home and put conventional footwear away and encourage patients' self‐efficacy and habitual use of therapeutic footwear. Future studies should investigate this topic further and explore ways to promote changes in habits. A study limitation was that all variables were self‐reported.