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.

Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2023 update).

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.

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.

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.

Global trends in the incidence of hospital admissions for diabetes-related foot disease and amputations: a review of national rates in the 21st century.

AIMS/HYPOTHESIS: Diabetic foot disease (DFD) is a leading cause of hospital admissions and amputations. Global trends in diabetes-related amputations have been previously reviewed, but trends in hospital admissions for multiple other DFD conditions have not. This review analysed the published incidence of hospital admissions for DFD conditions (ulceration, infection, peripheral artery disease [PAD], neuropathy) and diabetes-related amputations (minor and major) in nationally representative populations. METHODS: PubMed and Embase were searched for peer-reviewed publications between 1 January 2001 and 5 May 2022 using the terms 'diabetes', 'DFD', 'amputation', 'incidence' and 'nation'. Search results were screened and publications reporting the incidence of hospital admissions for a DFD condition or a diabetes-related amputation among a population representative of a country were included. Key data were extracted from included publications and initial rates, end rates and relative trends over time summarised using medians (ranges). RESULTS: Of 2527 publications identified, 71 met the eligibility criteria, reporting admission rates for 27 countries (93% high-income countries). Of the included publications, 14 reported on DFD and 66 reported on amputation (nine reported both). The median (range) incidence of admissions per 1000 person-years with diabetes was 16.3 (8.4-36.6) for DFD conditions (5.1 [1.3-7.6] for ulceration; 5.6 [3.8-9.0] for infection; 2.5 [0.9-3.1] for PAD) and 3.1 (1.4-10.3) for amputations (1.2 [0.2-4.2] for major; 1.6 [0.3-4.3] for minor). The proportions of the reported populations with decreasing, stable and increasing admission trends were 80%, 20% and 0% for DFD conditions (50%, 0% and 50% for ulceration; 50%, 17% and 33% for infection; 67%, 0% and 33% for PAD) and 80%, 7% and 13% for amputations (80%, 17% and 3% for major; 52%, 15% and 33% for minor), respectively. CONCLUSIONS/INTERPRETATION: These findings suggest that hospital admission rates for all DFD conditions are considerably higher than those for amputations alone and, thus, the more common practice of reporting admission rates only for amputations may substantially underestimate the burden of DFD. While major amputation rates appear to be largely decreasing, this is not the case for hospital admissions for DFD conditions or minor amputation in many populations. However, true global conclusions are limited because of a lack of consistent definitions used to identify admission rates for DFD conditions and amputations, alongside a lack of data from low- and middle-income countries. We recommend that these areas are addressed in future studies. REGISTRATION: This review was registered in the Open Science Framework database ( https://doi.org/10.17605/OSF.IO/4TZFJ ).

Cost-effectiveness of guideline-based care provision for patients with diabetes-related foot ulcers: A modelled analysis using discrete event simulation.

AIMS: The provision of guideline-based care for patients with diabetes-related foot ulcers (DFU) in clinical practice is suboptimal. We estimated the cost-effectiveness of higher rates of guideline-based care, compared with current practice. METHODS: The costs and quality-adjusted life-years (QALYs) associated with current practice (30% of patients receiving guideline-based care) were compared with seven hypothetical scenarios with increasing proportion of guideline-based care (40%, 50%, 60%, 70%, 80%, 90% and 100%). Comparisons were made using discrete event simulations reflecting the natural history of DFU over a 3-year time horizon from the Australian healthcare perspective. Incremental cost-effectiveness ratios were calculated for each scenario and compared to a willingness-to-pay of AUD 28,000 per QALY. Probabilistic sensitivity analyses were conducted to incorporate joint parameter uncertainty. RESULTS: All seven scenarios with higher rates of guideline-based care were likely cheaper and more effective than current practice. Increased proportions compared with current practice resulted in between AUD 0.28 and 1.84 million in cost savings and 11-56 additional QALYs per 1000 patients. Probabilistic sensitivity analyses indicated that the finding is robust to parameter uncertainty. CONCLUSIONS: Higher proportions of patients receiving guideline-based care are less costly and improve patient outcomes. Strategies to increase the proportion of patients receiving guideline-based care are warranted.

Editor's Choice - A Systematic Review and Meta-Analysis of the Incidence and Risk Factors for Re-admission to Hospital in People with Diabetes Related Foot Disease.

OBJECTIVE: The aim of this study was to systematically review the incidence and risk factors for 30 day re-admission to hospital following an index admission to treat diabetes related foot disease (DFD). DATA SOURCES: A literature search was conducted using Medline/PubMed, Scopus, Cochrane Library, and CINAHL databases. METHODS: The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Studies that reported the rate of total or DFD related 30 day re-admissions were included. Meta-analysis was performed using a random effects model to calculate the pooled mean (95% confidence interval [CI]) of the proportion of patients re-admitted to hospital within 30 days. Meta-regression was performed to determine the association between risk factors and 30 day re-admission. RESULTS: Sixteen retrospective studies with a total of 124 683 participants were included. The mean total 30 day re-admission rate was 22.0% (95% CI 17.0 - 27.0%) while the mean DFD related 30 day re-admission rate was 10.0% (95% CI 7.0 - 15.0%). Meta-regression found that greater prevalence of peripheral neuropathy (p = .045) was associated with a higher rate of any 30 day re-admission, and male sex (p = .023) and private health insurance (p = .048) were associated with lower rates of any 30 day re-admission. Coronary artery disease (p= .025) was associated with a higher rate of DFD related re-admission. All studies had low or moderate risk of bias. CONCLUSION: This systematic review suggested that about one fifth of patients with DFD are re-admitted to hospital within 30 days, of which about half are to treat DFD. Risk factors for re-admission included female gender, peripheral neuropathy, lack of private health insurance, and coronary artery disease.

Risk Factors for Hospital Re-admission for Diabetes Related Foot Disease: A Prospective Cohort Study.

OBJECTIVE: Diabetes related foot disease (DFD) is a common reason for admission to hospital, but the predictive factors for repeat admission are poorly defined. The primary aim of this study was to identify rates and predictive factors for DFD related hospital re-admission. METHODS: Patients admitted to hospital for treatment of DFD at a single regional centre were recruited prospectively between January 2020 and December 2020. Participants were followed for 12 months to evaluate the primary outcome of hospital re-admission. The relationship between predictive factors and re-admission were examined using non-parametric statistical tests and Cox proportional hazard analyses. RESULTS: The median age of the 190 participants was 64.9 (standard deviation 13.3) years and 68.4% were male. Forty-one participants (21.6%) identified themselves as Aboriginal or Torres Strait Islander people. One hundred participants (52.6%) were re-admitted to hospital at least once over 12 months. The commonest reason for re-admission was for treatment of foot infection (84.0% of first re-admission). Absent pedal pulses (unadjusted hazard ratio [HR] 1.90; 95% confidence interval [CI] 1.26 - 2.85), loss of protective sensation (LOPS) (unadjusted HR 1.98; 95% CI 1.08 - 3.62), and male sex (unadjusted HR 1.62; 95% CI 1.03 - 2.54) increased the risk of re-admission. After risk adjustment, only absence of pedal pulses (HR 1.92, 95% CI 1.27 - 2.91) and LOPS (HR 2.02, 95% CI 1.09 - 3.74) significantly increased the risk of re-admission. CONCLUSION: Over 50% of patients admitted to hospital for treatment of DFD are re-admitted within one year. Patients with absent pedal pulses and those with LOPS are twice as likely to be re-admitted.

Cohort Study Examining the Presentation, Distribution, and Outcomes of Peripheral Artery Disease in Aboriginal, Torres Strait Islander, and Non-Indigenous Australians.

OBJECTIVE: This retrospective cohort study investigated the anatomical distribution, severity, and outcome of peripheral artery disease (PAD) in Aboriginal and Torres Strait Islanders compared with non-indigenous Australians. METHODS: The distribution, severity, and outcome of PAD were assessed using a validated angiographic scoring system and review of medical records in a cohort of Aboriginal and Torres Strait Islander and non-indigenous Australians. The relationship between ethnicity and PAD severity, distribution, and outcome were examined using non-parametric statistical tests, Kaplan-Meier and Cox proportional hazard analyses. RESULTS: Seventy-three Aboriginal and Torres Strait Islanders and 242 non-indigenous Australians were included and followed for a median of 6.7 [IQR 2.7, 9.3] years. Aboriginal and Torres Strait Islander patients were more likely to present with symptoms of chronic limb threatening ischaemia (81% vs. 25%; p < .001), had greater median [IQR] angiographic scores for the symptomatic limb (7 [5, 10] vs. 4 [2, 7]) and tibial arteries (5 [2, 6] vs. 2 [0, 4]) and had higher risk of major amputation (HR 6.1, 95% CI 3.6 - 10.5; p < .001) and major adverse cardiovascular events (HR 1.5, 95% CI 1.0 - 2.3; p = .036) but not for revascularisation (HR 0.8, 95% CI 0.5 - 1.3; p = .37) compared with non-indigenous Australians. The associations with major amputation and major adverse cardiovascular events were no longer statistically significant when adjusted for limb angiographic score. CONCLUSION: Compared with non-indigenous patients, Aboriginal and Torres Strait Islander Australians had more severe tibial artery disease and a higher risk of major amputation and major adverse cardiovascular events.

Australian evidence-based guidelines for the prevention and management of diabetes-related foot disease: a guideline summary.

INTRODUCTION: Diabetes-related foot disease (DFD) - foot ulcers, infection, ischaemia - is a leading cause of hospitalisation, disability, and health care costs in Australia. The previous 2011 Australian guideline for DFD was outdated. We developed new Australian evidence-based guidelines for DFD by systematically adapting suitable international guidelines to the Australian context using the ADAPTE and GRADE approaches recommended by the NHMRC. MAIN RECOMMENDATIONS: This article summarises the most relevant of the 98 recommendations made across six new guidelines for the general medical audience, including: prevention - screening, education, self-care, footwear, and treatments to prevent DFD; classification - classifications systems for ulcers, infection, ischaemia and auditing; peripheral artery disease (PAD) - examinations and imaging for diagnosis, severity classification, and treatments; infection - examinations, cultures, imaging and inflammatory markers for diagnosis, severity classification, and treatments; offloading - pressure offloading treatments for different ulcer types and locations; and wound healing - debridement, wound dressing selection principles and wound treatments for non-healing ulcers. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINE: For people without DFD, key changes include using a new risk stratification system for screening, categorising risk and managing people at increased risk of DFD. For those categorised at increased risk of DFD, more specific self-monitoring, footwear prescription, surgical treatments, and activity management practices to prevent DFD have been recommended. For people with DFD, key changes include using new ulcer, infection and PAD classification systems for assessing, documenting and communicating DFD severity. These systems also inform more specific PAD, infection, pressure offloading, and wound healing management recommendations to resolve DFD.

A qualitative exploration of adherence to wearing removable cast walkers in patients with diabetic foot ulcers.

OBJECTIVE: To explore adherence to wearing removable cast walkers (RCWs) among patients with diabetic foot ulcers (DFUs). METHOD: A qualitative study was conducted by interviewing patients with active DFUs and using knee-high RCWs as their offloading treatment. The interviews were undertaken at two diabetic foot clinics in Jordan, using a semi-structured guide. Data were analysed through content analysis by developing main themes and categories. RESULTS: Following interviews with 10 patients, two main key themes with a total of six categories were identified: theme 1-reporting of adherence levels was inconsistent, included two categories: i) a belief in achieving optimal adherence, and ii) non-adherence was often reported indoors; and theme 2-adherence was a consequence of multiple psychosocial, physiological and environmental factors, which included four categories: i) specific offloading knowledge or beliefs influenced adherence; ii) severity of foot disease influenced adherence; iii) social support benefitted adherence; and iv) physical features of RCWs (the usability of the offloading device) impacted adherence. CONCLUSION: Patients with active DFUs reported inconsistent levels of adherence to wearing RCWs which, after deeper investigation, seemed to be due to participants' misperceptions of the optimal adherence. Adherence to wearing RCWs also seemed to be impacted by multiple psychosocial, physiological and environmental factors.

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.

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.

Efficacy of at home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: A meta-analysis.

AIMS: To perform an updated systematic review of randomised controlled trials examining the efficacy of at-home foot temperature monitoring in reducing the risk of a diabetes-related foot ulcer (DFU). METHODS: Systematic review performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk-of-bias was assessed using version 2 of the Cochrane risk-of-bias tool. Meta-analyses were performed using random effect models. Leave-one-out sensitivity analyses and a sub-analysis excluding trials considered at high risk-of-bias assessed the consistency of the findings. The certainty of the evidence was assessed with GRADE. RESULTS: Five randomised controlled trials involving 772 participants meeting the International Working Group on the Diabetic Foot (IWGDF) risk category 2 or 3 were included. All trials reported instructing participants to measure skin temperature at-home at six or more sites on each foot using a hand-held infra-red thermometer at least daily and reduce ambulatory activity in response to hotspots (temperature differences >2.2°C on two consecutive days between similar locations in both feet). One, one, and three trials were considered at low, moderate and high risk-of-bias, respectively. Participants allocated to at-home foot temperature monitoring had a reduced risk of developing a DFU (relative risk 0.51, 95% CI 0.31-0.84) compared to controls. Sensitivity and sub-analyses suggested that the significance of this finding was consistent. The GRADE assessment suggested a low degree of certainty in the finding. CONCLUSIONS: At-home daily foot temperature monitoring and reduction of ambulatory activity in response to hotspots reduce the risk of a DFU in moderate or high risk people with a low level of certainty.

Foot, ankle, and leg problems in Australian primary care: consultation patterns, management practices, and costs.

OBJECTIVE: To explore consultation patterns, management practices, and costs of foot, ankle, and leg problems in Australian primary care. STUDY DESIGN: We analyzed data from the Bettering the Evaluation and Care of Health program, April 2000 to March 2016. Foot, ankle, and leg problems were identified using the International Classification of Primary Care, Version 2 PLUS terminology. Data were summarized using descriptive statistics examining general practitioner (GP) and patient characteristics associated with a foot, ankle, or leg problem being managed. Cost to government was estimated by extracting fees for GP consultations, diagnostic imaging, and pathology services from the Medicare Benefits Schedule (MBS) database. Costs for prescription-only medicines were extracted from the Pharmaceutical Benefits Schedule and for nonprescribed medications, large banner discount pharmacy prices were used. RESULTS: GPs recorded 1,568,100 patient encounters, at which 50,877 foot, ankle, or leg problems were managed at a rate of 3.24 (95% confidence intervals [CIs] 3.21-3.28) per 100 encounters. The management rate of foot, ankle, or leg problems was higher for certain patient characteristics (older, having a health care card, socioeconomically disadvantaged, non-Indigenous, and being English speaking) and GP characteristics (male sex, older age, and Australian graduate). The most frequently used management practice was the use of medications. The average cost (Australian dollars) per encounter was A$52, with the total annual cost estimated at A$256m. CONCLUSIONS: Foot, ankle, and leg problems are frequently managed by GPs, and the costs associated with their management represent a substantial economic impact in Australian primary care.

Knee-High Devices Are Gold in Closing the Foot Ulcer Gap: A Review of Offloading Treatments to Heal Diabetic Foot Ulcers.

Diabetic foot ulcers (DFU) are a leading cause of the global disease burden. Most DFUs are caused, and prolonged, by high plantar tissue stress under the insensate foot of a person with peripheral neuropathy. Multiple different offloading treatments have been used to try to reduce high plantar tissue stress and heal DFUs, including bedrest, casting, offloading devices, footwear, and surgical procedures. The best offloading treatments are those that balance the benefits of maximizing reductions in high plantar tissue stress, whilst reducing the risks of poor satisfaction, high costs and potential adverse events outcomes. This review aimed to summarize the best available evidence on the effects of offloading treatments to heal people with DFUs, plus review their use in clinical practice, the common barriers and solutions to using these treatments, and discuss promising emerging solutions that may improve offloading treatments in future. Findings demonstrate that knee-high offloading devices, non-removable or removable knee-high devices worn for all weight-bearing activities, are the gold standard offloading treatments to heal most patients with DFU, as they are much more effective, and typically safer, quicker, and cheaper to use compared with other offloading treatments. The effectiveness of offloading treatments also seems to increase when increased offloading mechanical features are incorporated within treatments, including customized insoles, rocker-bottom soles, controlled ankle motion, and higher cast walls. However, in clinical practice these gold standard knee-high offloading devices have low rates of prescription by clinicians and low rates of acceptance or adherence by patients. The common barriers resulting in this low use seem to surround historical misperceptions that are mostly dispelled by contemporary evidence. Further, research is now urgently required to close the implementation gap between the high-quality of supporting evidence and the low use of knee-high devices in clinical practice to reduce the high global disease burden of DFU in future.

Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review.

BACKGROUND: Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers. METHODS: We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis. RESULTS: We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia. CONCLUSION: Strong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.

Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update).

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people with diabetes and updates the previous IWGDF guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a nonremovable knee-high offloading device is the first choice of offloading treatment. A removable knee-high and removable ankle-high offloading device are to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to nonremovable offloading exist. Appropriately, fitting footwear combined with felted foam can be considered as the fourth-choice offloading treatment. If non-surgical offloading fails, we recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment for healing ulcers that are complicated with infection or ischaemia and for healing plantar heel ulcers. Offloading is arguably the most important of multiple interventions needed to heal a neuropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalization, and amputation.

Definitions and criteria for diabetic foot disease.

Multiple disciplines are involved in the management of diabetic 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 diabetic foot disease. This document describes these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research to facilitate clear communication between professionals.

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease.

Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene, is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed.