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.

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.

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.

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.

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.

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait.

OBJECTIVE: Patient adherence is a challenge in offloading diabetic foot ulcers (DFUs) with removable cast walkers (RCWs). The size and weight of an RCW, changes to gait, and imposed limb-length discrepancies may all discourage adherence. This study sought to determine whether RCW size and provision of a contralateral limb lift affected users' comfort and gait. RESEARCH DESIGN AND METHODS: Twenty-five individuals at risk for DFUs completed several 20-m walking trials under five footwear conditions: bilateral standardized shoes, a knee-high RCW with shoe with or without an external shoe lift contralaterally, and an ankle-high RCW with shoe with or without an external shoe lift contralaterally. Perceived comfort ratings were assessed through the use of visual analog scales. Spatial and temporal parameters of gait were captured by an instrumented walkway, and plantar pressure was measured and recorded using pedobarographic insoles. RESULTS: The bilateral shoes condition was reported to be most comfortable; both RCW conditions without the lift were significantly less comfortable (P < 0.01). In contrast to the ankle-high RCW, the knee-high RCW resulted in significantly slower walking (5.6%; P < 0.01) but greater offloading in multiple forefoot regions of the offloaded foot (6.8-8.1%; P < 0.01). Use of the contralateral shoe lift resulted in significantly less variability in walking velocity (52.8%; P < 0.01) and reduced stance time for the offloaded foot (2.6%; P = 0.01), but it also reduced offloading in multiple forefoot regions of the offloaded foot (3.7-6.0%; P < 0.01). CONCLUSIONS: Improved comfort and gait were associated with the ankle-high RCW and contralateral limb lift. Providing this combination to patients with active DFUs may increase offloading adherence and subsequently improve healing.

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.

Association Between Second Metatarsal Length and Forefoot Loading Under the Second Metatarsophalangeal Joint.

BACKGROUND: Metatarsal length is believed to play a role in plantar plate dysfunction, although the mechanism through which progressive injury occurs is still uncertain. We aimed to clarify whether length of the second metatarsal was associated with increased plantar pressure measurements in the forefoot while walking. METHODS: Weightbearing radiographs and corresponding pedobarographic data from 100 patients in our practice walking without a limp were retrospectively reviewed. Radiographs were assessed for several anatomic relationships, including metatarsal length, by a single rater. Pearson correlation analyses and multiple linear regression models were used to determine whether metatarsal length was associated with forefoot loading parameters. RESULTS: The relative length of the second to first metatarsal was positively associated with the ratio of peak pressure beneath the respective metatarsophalangeal joints ( r = 0.243, P = .015). The relative length of the second to third metatarsal was positively associated with the ratios of peak pressure ( r = 0.292, P = .003), pressure-time integral ( r = 0.249, P = .013), and force-time integral ( r = 0.221, P = .028) beneath the respective metatarsophalangeal joints. Although the variability in loading predicted by the various regression analyses was not large (4%-14%), the relative length of the second metatarsal (to the first and to the third) was maintained in each of the multiple regression models and remained the strongest predictor (highest standardized ß-coefficient) in each of the models. CONCLUSIONS: Patients with longer second metatarsals exhibited relatively higher loads beneath the second metatarsophalangeal joint during barefoot walking. These findings provide a mechanism through which elongated second metatarsals may contribute to plantar plate injuries. LEVEL OF EVIDENCE: Level III, comparative study.

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.

Control of lower extremity edema in patients with diabetes: Double blind randomized controlled trial assessing the efficacy of mild compression diabetic socks.

AIMS: Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. METHODS: Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18-25mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). RESULTS: Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE circulation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. CONCLUSIONS: Results of this RCT suggest that mild compression diabetic socks may be effectively and safely used in patients with diabetes and LE edema.

Monitoring Location-Specific Physical Activity via Integration of Accelerometry and Geotechnology Within Patients With or At Risk of Diabetic Foot Ulcers: A Technological Report.

OBJECTIVE: Physical activity variability is a risk factor for diabetic foot ulcers (DFU). Geographic context may influence variability. This study developed initial methods for monitoring location-specific physical activity in this population. Secondarily, preliminary comparisons in location-specific physical activity were made between patients at risk versus patients with active DFU. METHODS: Five at-risk and 5 actively ulcerated patients were monitored continuously for 72 hours with physical activity and GPS monitors. A custom algorithm time synchronized the 2 devices' data. RESULTS: On average for all 10 subjects, 1.5 ± 2.1% of activity lacked a corresponding GPS location. 80 ± 11% of self-reported activity events per subject had a GPS identified location. The GPS identified locations were in agreement with the self-reported locations 98 ± 6% of the time. DFU participants' weight-bearing activity was 188% higher at home than away from home. At-risk participants showed similar weight-bearing activity at home as active DFU participants, however, at-risk participants had 132% more weight-bearing activity away-from-home. CONCLUSIONS: Objectively monitoring location-specific physical activity proved feasible. Future studies using such methodology may enhance understanding of pathomechanics and treatment of DFU.

Preliminary Evaluation of a Cycling Cleat Designed for Diabetic Foot Ulcers.

BACKGROUND: Offloading devices for diabetic foot ulcers (DFU) generally restrict exercise. In addition to traditional health benefits, exercise could benefit DFU by increasing blood flow and acting as thermotherapy. This study functionally evaluated a cycling cleat designed for forefoot DFU. METHODS: Fifteen individuals at risk of developing a DFU used a recumbent stationary bicycle to complete one 5-minute cycling bout with the DFU cleat on their study foot and one 5-minute bout without it. Foot stress was evaluated by plantar pressure insoles during cycling. Laser Doppler perfusion monitored blood flow to the hallux. Infrared photographs measured foot temperature before and after each cycling bout. RESULTS: The specialized cleat significantly reduced forefoot plantar pressure (9.9 kPa versus 62.6 kPa, P < .05) and pressure time integral (15.4 versus 76.4 kPa*sec, P < .05). Irrespective of footwear condition, perfusion to the hallux increased (3.97 ± 1.2 versus 6.9 ± 1.4 tissue perfusion units, P < .05) after exercise. Infrared images revealed no changes in foot temperature. CONCLUSIONS: The specialized cleat allowed participants to exercise with minimal forefoot stress. The observed increase in perfusion suggests that healing might improve if patients with active DFU were to use the cleat. Potential thermotherapy for DFU was not supported by this study. Evaluation of the device among individuals with active DFU is now warranted.

Role and Determinants of Adherence to Off-loading in Diabetic Foot Ulcer Healing: A Prospective Investigation.

OBJECTIVE: Studies indicate that off-loading adherence is low in patients with diabetic foot ulcers (DFUs), which may subsequently delay healing. However, there is little empirical evidence for this relationship or the factors that influence adherence. RESEARCH DESIGN AND METHODS: This prospective, multicenter, international study of 79 (46 from the U.K. and 33 the U.S.) persons with type 2 diabetes and plantar DFUs assessed the association between off-loading adherence and DFU healing over a 6-week period. Additionally, potential demographic, disease, and psychological determinants of adherence were examined. DFUs were off-loaded with a removable device (77% a removable cast walker). Off-loading adherence was assessed objectively by activity monitors. Patient-reported measures included Hospital Anxiety and Depression Scale (HADS), Neuropathy and Foot Ulcer Quality of Life (NeuroQoL) instrument, and Revised Illness Perception Questionnaire (IPQ-R). RESULTS: Off-loading adherence was monitored for 35 ± 10 days, and devices were used during 59 ± 22% of subjects' activity. In multivariate analyses, smaller baseline DFU size, U.K. study site, and better off-loading adherence predicted smaller DFU size at 6 weeks (P < 0.05). Better off-loading adherence was, in turn, predicted by larger and more severe baseline DFUs, more severe neuropathy, and NeuroQoL foot pain (P < 0.05). In contrast, greater NeuroQoL postural instability predicted worse off-loading adherence (P < 0.001). HADS and IPQ-R measures were not significantly associated with off-loading adherence. CONCLUSIONS: Off-loading adherence is associated with the amount of DFU healing that occurs, while postural instability is a powerful predictor of nonadherence. Clinicians should take this neuropathic symptom into consideration when selecting an off-loading device, as off-loading-induced postural instability may further contribute to nonadherence.

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.