Abstract
BackgroundRecurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is designed to influence multifaceted mechanisms of foot ulcer occurrence. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU).Methods/designThe trial is designed as a two arms, parallel-group, open-label randomized controlled intervention study. The Log-rank Test was used for calculating sample size based on the latest national multicenter survey data of DFU in China. Three hundred and twenty participants will be recruited from the Diabetic Foot Care Center, West China Hospital, Sichuan University. Adults with diabetic peripheral neuropathy, healed foot ulceration in the 3 months prior to randomization, and aged ≥18 years, will be recruited. Participants will be randomized to receive novel diabetic therapeutic footwear (n = 160) or their own footwear (n = 160). The primary outcome will be the incidence of ulcer recurrence. The secondary outcome will be measurements of barefoot dynamic plantar pressures, the influence of footwear adherence on ulcer recurrence, and the incidence of cardiovascular events. Assessment visits and data collection will be obtained at baseline, 1, 3, 6, 9, and 12 months. The intention-to-treat principle will be applied. A cox regression model will be used to calculate the hazard ratio for the incidence of ulcer recurrence. The change of barefoot dynamic plantar pressures will be assessed using repeated measures ANOVA. The study protocol has been approved by the Ethics Committee of The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2019(96)).DiscussionThis clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients.Trial registrationChinese Clinical Trial Registry ChiCTR1900025538. Registered on 31 August 2019.
Highlights
Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus
If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients
Over the past two decades, whether therapeutic footwear prescribed for patients with diabetic foot was effective to prevent ulcer recurrence remains controversial
Summary
Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU). The development of foot ulcers is a significant marker of the extent of long-term complications in patients with diabetes mellitus, which is the most common reason for lower limb amputation [1]. Diabetes-related foot ulcers precede at least 60% of all nontraumatic lower limb amputations [2]. A recent large cohort study in China showed that the incidence rate for foot ulcer recurrence within 1 year reached 31.6% [5]. Prevention of ulcer recurrence or occurrence is of prime importance in the current approach to diabetic foot disease
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