Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, Sichuan, 610041, People's Republic of China.
Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Chengdu, 610041, People's Republic of China.
Trials. 2021 Feb 17;22(1):151. doi: 10.1186/s13063-021-05098-8.
Recurrence 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/DESIGN: The 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)).
This 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.
Chinese Clinical Trial Registry ChiCTR1900025538 . Registered on 31 August 2019.
糖尿病患者足部溃疡愈合后复发非常常见。新型糖尿病治疗鞋采用美利奴羊毛、振动芯片和矫形鞋垫设计，旨在影响足部溃疡发生的多方面机制。本研究旨在探讨优化设计的治疗鞋在预防有糖尿病足溃疡（DFU）病史的患者溃疡复发中的作用。
方法/设计：该试验设计为双臂、平行组、开放标签随机对照干预研究。根据中国最新的全国多中心 DFU 调查数据，采用对数秩检验计算样本量。将从四川大学华西医院糖尿病足护理中心招募 320 名参与者。纳入标准为：糖尿病周围神经病变患者、随机分组前 3 个月内愈合的足部溃疡、年龄≥18 岁。参与者将被随机分为新型糖尿病治疗鞋组（n=160）或自己的鞋组（n=160）。主要结局是溃疡复发的发生率。次要结局是足底压力的动态足底压力测量、鞋的适应性对溃疡复发的影响以及心血管事件的发生率。在基线、1、3、6、9 和 12 个月时进行评估和数据收集。将采用意向治疗原则。Cox 回归模型将用于计算溃疡复发发生率的风险比。将使用重复测量 ANOVA 评估足底压力的变化。该研究方案已获得四川大学华西医院生物医学伦理委员会伦理审查委员会的批准（参考编号 2019(96)）。
这项临床试验将提供关于新型糖尿病鞋预防糖尿病足溃疡病史患者溃疡复发能力的信息。如果优化设计的治疗鞋效果良好，研究结果将有助于开发创新的治疗设备，以预防高危患者的足部溃疡复发。
中国临床试验注册中心 ChiCTR1900025538 。注册于 2019 年 8 月 31 日。
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