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Effects of Novel Diabetic Therapeutic Footwear on Preventing Ulcer Recurrence in Patients with a History of Diabetic Foot Ulceration: Study Protocol for an Open-label, Randomized, Controlled Trial by Yun Gao; Chun Wang; Dawei Chen; Hui Huang; Lihong Chen; Guanjian Liu; Shuang Lin; Min Liu; Xiaorong Wen; Jae-Hoon Cho; Yong Chen; Yingzhu Li; Xingwu Ran is a Medicine article available to read on EtoBox.
What is Effects of Novel Diabetic Therapeutic Footwear on Preventing Ulcer Recurrence in Patients with a History of Diabetic Foot Ulceration: Study Protocol for an Open-label, Randomized, Controlled Trial about?
## Abstract ## Background 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
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- Author
- Yun Gao; Chun Wang; Dawei Chen; Hui Huang; Lihong Chen; Guanjian Liu; Shuang Lin; Min Liu; Xiaorong Wen; Jae-Hoon Cho; Yong Chen; Yingzhu Li; Xingwu Ran
- Publisher
- Springer Science and Business Media LLC
- Published
- 2021
- Language
- EN
- Field
- Medicine (Health Sciences)