An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes. METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively. DISCUSSION: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Effect of a carbon reinforcement for maximizing shoe outsole bending stiffness on plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration.

BACKGROUND: Different shoe design features can reduce peak plantar pressure to help prevent foot ulcers in people with diabetes. A carbon reinforcement of the shoe outsole to maximize bending stiffness is commonly applied in footwear practice, but its effect has not been studied to date. RESEARCH QUESTION: What is the effect of a carbon shoe-outsole reinforcement on peak plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration? METHODS: In 24 high-risk people with diabetes, in-shoe regional peak pressures were measured during walking at a comfortable speed in two different shoe conditions: an extra-depth diabetes-specific shoe with a non-reinforced outsole and the same type of shoe with a 3-mm-thick full-length carbon reinforcement of the outsole. The same custom-made insole was worn in both shoe conditions. Walking comfort was assessed using a Visual Analogue Scale (0-10, 10 being highest possible comfort). RESULTS: Significantly lower metatarsal head peak pressures (by a median 10-22 kPa) were found with the reinforced shoe compared to the non-reinforced shoe (p < .001). In >83% of cases with the reinforced shoe and >71% with the non-reinforced shoe metatarsal head peak pressures were <200 kPa. At the hindfoot, peak pressures were significantly higher (by a median 24 kPa) with the reinforced shoe (p = .001). No significant shoe effects were found for the toes. No significant shoe effects were found for walking comfort: median 6.1 for the reinforced shoe versus 5.6 for the non-reinforced shoe. SIGNIFICANCE: Adding a full-length carbon reinforcement to the outsole of a diabetes-specific shoe significantly reduces peak pressures at the metatarsal heads, where ulcers often occur, in high-risk people with diabetes, and this does not occur at the expense of patient-perceived walking comfort.

Optimizing footwear for the diabetic foot: Data-driven custom-made footwear concepts and their effect on pressure relief to prevent diabetic foot ulceration.

AIMS: To assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration. METHODS: Twenty-four neuropathic diabetic patients at high risk of foot ulceration were measured for in-shoe plantar pressures during walking in four data-driven custom-made footwear conditions, an athletic shoe and an off-the-shelf non-therapeutic shoe. Two evidence-based footwear conditions (Shoe-A; Insole-A) follow a scientific-based design protocol, are handmade, and use in-shoe plantar pressure guided optimization. One evidence-based insole condition (Insole-B) uses a barefoot plantar pressure and 3D foot shape-based computer-assisted design and manufacturing (CADCAM) routine. And one insole condition (Insole-C) uses a barefoot and in-shoe plantar pressure and 3D foot shape-based CADCAM design and optimization routine. Patient satisfaction was scored on walking comfort, shoe fit, weight and appearance. RESULTS: All data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17-53% relief). Shoe-A and Insole-A showed the lowest metatarsal head peak pressures (mean 112-155 kPa, 90-98% of cases <200 kPa), significantly lower than for Insole-B and Insole-C (mean 119-199 kPa, 52-100% <200 kPa). Patient satisfaction was not significantly different between footwear concepts. CONCLUSIONS: This study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention.

Functional outcome and patient satisfaction after flexor tenotomy for plantar ulcers of the toes.

Ulcers of the toes may cause a severe physical burden, especially in patients with diabetes, in whom they occur most frequently. Several treatments have been proposed for the underlying anatomical abnormalities, but they vary in effectiveness. We evaluated our results in using flexor tenotomy to treat ulcers with underlying flexible clawing of the toes. For 42 toes from 23 patients, 15 of whom were diabetic, all ulcers healed. The mean healing time was 4 weeks (range, 1-8 weeks), the mean follow-up was 11 months (range, 1-27 months), and one recurrence and one complication occurred. Postoperative American Orthopaedic Foot Ankle Society Midfoot scores were available for 15 patients: the mean was 77 (range, 43-100). The mean visual analogue scale (VAS) for patient satisfaction increased from 3.9 points (range, 0-10 points) preoperatively to 7.7 (range, 5-10 points) postoperatively. Flexor tenotomy is a simple treatment with low complications and recurrence rates and provides good-to-excellent functional outcomes in treating flexible clawing of the toes and the associated ulceration.