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.

Recent Advances and Future Opportunities to Address Challenges in Offloading Diabetic Feet: A Mini-Review.

Diabetic foot ulcers (DFU) are a substantial dilemma for geriatric individuals with diabetes. The breakdown in tissue associated with DFU is typically a result of repetitive cycles of physical stress placed on the feet during weight-bearing activity. Accordingly, a key tenet in healing as well as preventing DFU is the use of offloading footwear to redistribute physical stress away from high stress locations such as bony prominences. Over the last several years there has been a substantial amount of effort directed at better understanding and implementing the practice of offloading. A review of this work as well as relevant technological advances is presented in this paper. Specifically, we will discuss the following topics in association with offloading diabetic feet: achieving optimal offloading, dosing activity/physical stress, thermal monitoring to detect preulcerative tissue damage, adherence with offloading devices, and optimizing the user experience. In addition to presenting progress to date, potential directions for further advancement are discussed.

Psychological and Biomechanical Aspects of Patient Adaptation to Diabetic Neuropathy and Foot Ulceration.

PURPOSE OF REVIEW: The purpose of this review was to elucidate how psychological and biomechanical factors interrelate in shaping patients' experience with diabetic symmetric polyneuropathy (DSPN) and its sequela-diabetic foot ulceration (DFU). RECENT FINDINGS: Recent findings emphasize the importance not only of neuropathic pain but also of other DSPN symptoms, such as unsteadiness. We highlight the negative spiral between unsteadiness, falls, and psychological distress. Moreover, unsteadiness is a key determinant of non-adherence to offloading resulting in the delayed DFU healing. While depression is an established predictor of incident DFU, findings linking depression and DFU healing remain inconclusive. Examination of physical activity in DFU development and healing represents the most recent application of research to this field. Research evidence indicates that DSPN markedly impairs physical and emotional functioning and suggests that there is an unmet need for the development of multifaceted interventions that address both psychological distress and biomechanical challenges experienced by patients with this debilitating complication of diabetes.

Physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers: a critical review.

Obesity and a sedentary lifestyle are common challenges among individuals at risk of diabetic foot ulcers. While substantial research exists on physical activity interventions in adults with diabetes, those at greatest risk for foot ulceration were often excluded or not well represented. Both at-risk patients and their clinicians may be hesitant to increase physical activity because of their perception of diabetic foot ulcer risks. Physical activity is not contraindicated for those at risk of diabetic foot ulcer, yet patients at risk present with unique barriers to initiating increases in physical activity. This review focuses upon the physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers. Offloading, diabetic peripheral neuropathy, depression, pain, self-efficacy and social support, diabetic foot ulcer risk-specific beliefs and emotions, and research to date on exercise interventions in this population are all discussed. Additionally, recommendations for implementing and researching physical activity interventions for individuals at risk for diabetic foot ulcer are provided. Copyright © 2016 John Wiley & Sons, Ltd.

Prognostic Value of Diagnostic Sonography in Patients With Plantar Fasciitis.

OBJECTIVES: The primary objective of this study was to determine whether the sonographic appearance of the plantar fascia is predictive of the treatment (ie, pain) response in patients receiving supportive therapy for proximal plantar fasciitis. This study was a secondary analysis of data obtained from a randomized controlled trial of ambulatory adults, which examined the efficacy of 3 different foot supports for plantar fasciitis. METHODS: Participants underwent diagnostic sonographic examinations of their heel at baseline and again at 3 months by a single experienced foot and ankle surgeon. Quantitative (eg, thickness) and qualitative (eg, biconvexity) characteristics of the fascia were recorded according to a standard protocol. Logistic regression models were used to identify predictors of the pain response. RESULTS: Seventy patients completed a baseline evaluation, and 63 patients completed a 3-month follow-up assessment. The pain response was not associated with the type of foot support (P> .05). The only significant indicator of an unfavorable response in the univariate and multivariate analyses was biconvexity of the plantar fascia on sonography at presentation (multivariate odds ratio, 4.76 [95% confidence interval, 1.16-19.5; P= .030). Furthermore, changes in self-reported pain over the 3-month study period were not accompanied by alterations in plantar fascia thickness over this time (r = .056; P = .671). CONCLUSIONS: We conclude that patients who present with biconvexity of the plantar fascia may be less responsive to tier 1 treatment regimens that center around mechanical support of the plantar fascia. Furthermore, follow-up measurements of the fascia in this population should not weigh heavily in decisions such as return to play.

A novel plantar stimulation technology for improving protective sensation and postural control in patients with diabetic peripheral neuropathy: a double-blinded, randomized study.

BACKGROUND: Many diabetes-related peripheral neuropathy (DPN) patients also experience postural instability. OBJECTIVE: This study examined the effect of electrical stimulation therapy on DPN patients' postural control as well as recovery of plantar sensation. METHODS: 54 patients with mild to moderate DPN were enrolled into this study evaluating treatment of DPN with electrical stimulation provided via aqueous solution. The subjects were randomized into either sham or active stimulation. Treatments were administered 5 times per week for 6 weeks. Changes in neuropathy severity were assessed via Semmes-Weinstein monofilament tests and vibration perception threshold (VPT) tests. The potential benefit in postural control was assessed in a subsample of 13 subjects by measuring the area of center of mass (COM) sway. RESULTS: The active group saw a significant (p < 0.05) improvement in VPT at treatment week 6 in comparison to the sham group. The difference did not remain significant at follow-up visits. There were no significant differences between groups for the Semmes-Weinstein monofilament test. However, time was a significant main effect, with both groups improving over the course of the study. The area of COM sway was significantly reduced on average by 36% at treatment week 2 compared to the baseline. Although at treatment week 6 an additional 7% reduction in COM sway was observed compared to treatment week 2, the improvement from treatment week 2 to treatment week 6 was not significant (p > 0.6). Interestingly, no significant difference was observed in the sham group during the study (p > 0.7). CONCLUSION: This randomized pilot study provides preliminary data on the potential of electrical stimulation via aqueous solution to improve protective sensation and postural stability in DPN patients.

Diabetes and Reactive Balance: Quantifying Stepping Thresholds With a Simple Spring Scale to Measure Fall-Risk in Ambulatory Older Adults.

BACKGROUND: Fall-risk assessments for patients with diabetes fail to consider reactive responses to balance loss. The purpose of this study was to assess the feasibility of using a simple clinical tool to evaluate the impact of diabetes and fall history on reactive balance in older adults. METHODS: We recruited 72 older adults with and without diabetes. Postural perturbations were applied by a waist-mounted spring scale. Stepping thresholds (STs) in the anterior and posterior directions were defined as the lowest spring-loads that induced a step. Balance was assessed via the National Institutes of Health Toolbox Standing Balance Test, and lower extremity sensation was assessed using vibratory perception threshold and Semmes-Weinstein monofilaments. Fall history over the past year was self-reported. Cox regressions and analysis of variance were used to compare hazard rates for stepping and observed STs between groups. RESULTS: Anterior STs were elicited in 42 subjects and posterior STs in 65 subjects. Hazard rates for posterior ST were significantly affected by diabetes, with greater hazards for fallers with diabetes versus control fallers and nonfallers, after accounting for balance and sensory loss. For those who stepped, ST was lower in the posterior direction for the diabetes group. Additionally, anterior but not posterior ST was lower in all fallers vs all nonfallers. CONCLUSIONS: The waist-mounted spring scale is a clinically implementable device that can assess ST in older adults with diabetes. Using the device, we demonstrated that ST was affected by diabetes and could potentially serve as a fall-risk factor independent of balance or sensory loss.

Changing Perspectives: Offloading a Patient With a Diabetic Foot Ulcer as Opposed to Offloading a Diabetic Foot Ulcer.

Diabetic foot ulcers (DFUs) represent a tremendous burden to health care systems. Offloading is one of the key tenants to healing DFU and knee-high irremovable offloading devices are considered the gold standard for offloading DFU. However, the gold standard is rarely utilized in clinical practice. Patients' limited tolerance for such devices is one of a number of reasons that have been attributed to the lack of use of these devices. The practice of evidence-based medicine relies on shared decision making by pairing patients' values and preferences with the best available evidence. The present case report reviews the process of a patient-centered approach to identify the best offloading option for a patient with DFU. In consultation with the patient, a series of modalities were evaluated for offloading 2 unilateral forefoot DFUs. It is suggested that optimizing DFU offloading outcomes at the population level will require concerted efforts to employ the best offloading solution at the individual patient level. Offloading modalities are necessitated to mitigate the physical stress imparted on DFU during the weightbearing activity that patients engage in. Success is likely to be maximized by maintaining a mind-set of treating individual patients with DFUs as opposed to simply treating DFUs.Levels of Evidence: Level V: Case report.

Should weight-bearing activity be reduced during healing of plantar diabetic foot ulcers, even when using appropriate offloading devices?

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.

Creating a diabetes foot reminder-based registry using the electronic medical record.

OBJECTIVE: We created a new diabetes foot examination clinical reminder to directly populate a foot risk registry and examined its accuracy versus administrative data. METHODS: A pre- and post-test design assessed accuracy of coding foot risk and clinician acceptability. The intervention hospital's reminder was replaced with a dialogue tick box containing the International Diabetic Foot Classification System to populate risk using health factors. RESULTS: There were no hospital agreement differences for each foot condition except diabetes and peripheral neuropathy, demonstrating higher agreement at the intervention hospital. There were no differences in service agreement adherence or consulting rates although both demonstrated significantly lower consulting rates at study end. The intervention hospital had a significantly lower patient cancellation rate (1% v. 5%, P=0.01) and better coding for grade 3 patients. The new reminder demonstrated high acceptability. CONCLUSIONS: The registry system resulted in improved discrimination of the highest foot risk. Further testing is recommended.

The Role of the Podiatrist in Assessing and Reducing Fall Risk: An Updated Review.

Falls present a tremendous challenge to health care systems. This article reviews the literature from the previous 5 years (2014-2019) in terms of methods to assess fall risk and potential steps that can be taken to reduce fall risk for patients visiting podiatric clinics. With regard to assessing fall risk, we discuss the role of a thorough medical history and podiatric assessments of foot problems and deformities that can be performed in the clinic. With regard to fall prevention we consider the role of shoe modification, exercise, pain relief, surgical interventions, and referrals.

Offloading for the Diabetic Foot: Considerations and Implications.

Offloading the diabetic foot remains the major consideration for ulceration prevention and healing. This narrative literature review presents a brief overview of current guidelines for offloading the diabetic foot and discusses the implications that come with offloading treatment modalities and their effects on the kinetic chain of the lower extremity. We also present the latest innovative studies from the Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science that advance the knowledge in this field and provide avenues for future research opportunities.

Choosing a Vibratory Test to Pair With Semmes Weinstein Monofilament Testing for Evaluating Lower Extremity Sensation in Patients With Diabetes: A Comparison of Three Vibratory Methodologies.

BACKGROUND: Numerous guidelines recommend pairing Semmes-Weinstein monofilament (SWM) testing with a secondary clinical test when screening for diabetic peripheral neuropathy, yet time is very limited in clinical practice. This study compared the time to complete and the diagnostic agreement of three vibratory sensation tests. METHODS: Sixty-five individuals (42% male; aged: 61 ± 12 years) were recruited. A single investigator administered the following tests bilaterally: 10-site SWM, traditional tuning fork (TTF), electronic tuning fork (ETF), and vibration perception threshold (VPT) via biothesiometer. Times to physically administer the tests were compared with a one-way repeated measures ANOVA. Cochran's Q test was used to compare the varied tests' diagnostic agreement. RESULTS: The ANOVA indicated there were significant (P < .001, partial eta squared = .442) differences in time to complete the varied tests. Sidak post hoc comparisons indicated the VPT (21.2 ± 14.3) testing took an intermediate time to complete, while the ETF (9.7 ± 6.5) and TTF (10.1 ± 7.5) tests took the least amount of time, and the SWM (28.6 ± 8.4) test took the longest time. There were also numerous significant differences (P ≤ .001) between the different tests in regards to neuropathy diagnoses. CONCLUSIONS: Tuning fork methods required 11 seconds less to administer than VPT testing. Although that may seem trivial, it is worth noting peripheral neuropathy screening often fails to occur in the precious few minutes clinicians are allotted per patient. Considering ETF's intrinsic control of stimulus amplitude and its ease of use with an embedded timer, the ETF is recommended over the TTF. Clinicians should also be mindful that different tests yield different diagnostic conclusions.

A method for assessing off-loading compliance.

BACKGROUND: Off-loading excessive pressure is essential to healing diabetic foot ulcers. However, many patients are not compliant in using prescribed footwear or off-loading devices. We sought to validate a method of objectively measuring off-loading compliance via activity monitors. METHODS: For 4 days, a single subject maintained a written compliance diary concerning use of a removable cast walker. He also wore a hip-mounted activity monitor during all waking hours. An additional activity monitor remained mounted on the cast walker at all times. At the conclusion of the 4 days, the time-stamped hip activity data were independently coded for walker compliance by the compliance diary and by using the time-stamped walker activity data. RESULTS: An intraclass reliability of 0.93 was found between diary-coded and walker monitor-coded activity. CONCLUSIONS: These results support the use of this dual activity monitor approach for assessing off-loading compliance. An advantage of this approach versus a patient-maintained diary is that the monitors are not susceptible to incorrect patient recall or a patient's desire to please a caregiver by reporting inflated compliance. Furthermore, these results seem to lend support to existing reports in the literature using similar methods.

Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study.

This 12-week, prospective, randomised, controlled multi-centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty-six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre-treatment ulcer data were calculated. Complete healing and mean healing time were 69.6% and 5.7 weeks, respectively, for the study group and 46.2% and 6.8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (P = 0.0289), with odds of healing in the study group 2.7 times higher than in the control group. Kaplan-Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate (P = 0.015) for the control group (53.9%) compared with the study group (30.4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (P = 0.0194), a statistically significant difference in non healing rate between groups was calculated (P = 0.0233), with odds of healing 2.0 times higher in the study versus control group. This study supports the use of single-application AM therapy as an effective treatment of diabetic, neuropathic ulcers.

Measuring Plantar Tissue Stress in People With Diabetic Peripheral Neuropathy: A Critical Concept in Diabetic Foot Management.

Excessive stress on plantar tissue over time is one of the leading causes of diabetic foot ulcers among people with diabetic peripheral neuropathy. Plantar tissue stress (PTS) is a concept that attempts to integrate several well-known mechanical factors into one measure, including plantar pressure, shear stress, daily weight-bearing activity, and time spent in prescribed offloading interventions (adherence). Despite international diabetic foot guidelines recommending the measure of each of these individual mechanical factors in people with neuropathy, only recently has technology enabled their combined measurement to determine PTS. In this article we review the concept of PTS, the mechanical factors involved, and the findings of pivotal articles reporting measures of PTS in people with neuropathy. We also discuss key existing gaps in this field, including the lack of standards to measure and report PTS, a lack of practical solutions to measure shear stress, and the lack of PTS thresholds that may indicate benefit or detriment to people with neuropathy. To address some of these gaps, we propose recommended clinical and research standards for measuring and reporting PTS in people with neuropathy. Last, we forecast future clinical, research, and technological advancements that may use PTS to highlight the importance of this critical concept in the prevention and management of diabetic foot ulcers.

Feasibility of a Low-Intensity, Technology-Based Intervention for Increasing Physical Activity in Adults at Risk for a Diabetic Foot Ulcer: A Mixed-Methods Study.

BACKGROUND: Among adults with diabetes, 19-34% will develop a diabetic foot ulcer (DFU), which increases amputation risk and health care costs, and worsens quality of life. Regular physical activity, when increased gradually, may help prevent DFUs. In this mixed-methods study, we examined the feasibility of a low-intensity, technology-based behavioral intervention to increase activity in adults at risk for DFUs. METHOD: Participants at risk for a DFU (n = 12; 66% female; mean age = 59.9 years) received four in-person exercise and behavioral counseling sessions over 2-3 weeks, supplemented with use of an activity monitor (to track steps) and text messages (to reinforce behavioral strategies) for an added 8 weeks. Pre- and postintervention assessments of accelerometer measured activity, daily mobility, and glycemic control (A1C) were completed. Treatment acceptability was assessed by questionnaire and via key informant interview. RESULTS: The program appears feasible since all but one participant attended all four sessions, all used the activity monitor and all responded to text messages. Treatment acceptability (scale: 1 = very dissatisfied, 5 = extremely satisfied) was high; average item ratings were 4.79 (SD = 0.24). Participants increased their steps by an average of 881.89 steps/day (d = 0.66). A1C decreased on average by 0.33% (d = 0.23). Daily mobility did not change. Interview results suggest that participants perceived benefits from the intervention. Participant recommended improvements included providing more physical activity information, addressing pain, and intervention delivery in a podiatry clinic. CONCLUSION: Individuals at risk for a DFU might benefit from a minimally intensive, technology-based intervention to increase their physical activity. Future research comparing the intervention to usual care is warranted.

CLEAR Cleat: a proof-of-concept trial of an aerobic activity facilitator to reduce plantar forefoot pressures and their potential in those with foot ulcers.

BACKGROUND: Exercise has not been studied extensively in persons with active neuropathic diabetic foot wounds, primarily because a device does not exist that allows patients to exercise while sufficiently off-loading pressure at the ulcer site. The purpose of this project was to demonstrate a device that reduces cycling plantar forefoot pressure. METHODS: Ten healthy participants rode a recumbent bicycle under three cycling conditions. While the left foot interaction remained constant with a standard gym shoe and pedal, the right foot was exposed to a control condition with standard gym shoe and pedal, gym shoe and specialized cleat, and gym shoe with an off-loading insole and specialized cleat. Pressure and contact area of the plantar aspect of the feet were recorded for a 10-sec interval once during each minute of each condition's 7-min trial. RESULTS: The off-loading insole and specialized cleat condition yielded significantly lower (P < .01) peak pressure, contact area, and pressure-time integral values in the forefoot than the specialized cleat condition with gym shoe, which yielded significantly lower values (P < .01) than the standard gym shoe and pedal. CONCLUSION: Modifications to footwear may alter plantar forefoot pressures, contact area, and pressure-time integrals while cycling. The CLEAR Cleat could play a significant role in the facilitation of fitness in patients with (or at high risk for) neuropathic wounds.

Physical management of the Charcot foot.

Charcot arthropathy places individuals at risk of developing diabetic foot ulcers and potentially subsequent limb amputation by means of altering the anatomy of the foot and ankle. Physical trauma is an important component to the etiology of the condition. The physical management of the Charcot foot is concerned with minimizing the stress applied to the affected foot and ankle skeletal structure. The most appropriate device is temporally dependent on the progression of the disease. At the initiation of Charcot arthropathy, care by total contact cast is recommended. As the affected bones begin to heal, use of a removable cast walker may be implemented. When the bones reach a fixed state, appropriate footwear is dictated by the degree of deformity.

Use of chlorhexidine-impregnated patch at pin site to reduce local morbidity: the ChIPPS Pilot Trial.

Pin tract infection is one of the most common complications associated with the use of external fixation. While some studies have identified the potential benefit of chlorhexidine gluconate-impregnated polyurethane dressings to reduce the incidence of catheter-related bloodstream infections, we are unaware of any published studies that evaluate the effectiveness of similar technologies in reducing the risk for external-fixation-related pin tract infections. Therefore, the purpose of this study was to evaluate the effectiveness of chlorhexidine gluconate-impregnated polyurethane dressing in reducing percutaneous-device-related skin colonisation and local infections. In this initial retrospective cohort, data were abstracted for two groups of consecutive patients undergoing surgery involving external fixation at an interdisciplinary foot and ankle surgical unit. All patients received surgical treatment of their foot/ankle pathology along with application of a hybrid external fixator. Twenty patients (45% male, age 54.5 +/- 3.69 years) received chlorhexidine gluconate-impregnated polyurethane dressing and twenty (55% male, age 55.8 +/- 3.22 years) received standard pin care. There was a significantly higher rate of pin tract infection in patients who received standard pin care compared with those who received chlorhexidine gluconate-impregnated polyurethane dressings (25% versus 0%, P = 0.047). There was no significant difference in any of the descriptive study characteristics (age, gender, diabetes and presence of neuropathy). The results of this initial study suggest that chlorhexidine gluconate-impregnated polyurethane dressing may be effective to reduce the incidence of pin tract infections and help decrease morbidity associated with external fixation.