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Efficacy of Vitamin C Treatment to Aid the Healing of Foot Ulcers in People With Diabetes: A Randomised, Placebo-Controlled Double-Blind Trial: The FOOT-C Study Protocol

作者:Kaminski MR, Thong E, Mason S, Abbott G, Lemoh C, Wong J, van der Pligt P, Lu Z, Golder J, Kwon JH, Wadley GD · 发表于:Journal of foot and ankle research · 年份:2026 · DOI:10.1002/jfa2.70193 · 被引用次数:57 · 研究领域:Ascorbic Acid、Diabetic Foot、Wound Healing、Vitamins、Humans、Double-Blind Method、Female、Male、Adult、Middle Aged、Randomized Controlled Trials as Topic、Treatment Outcome

INTRODUCTION: Diabetes-related foot ulceration (DFU) is a serious complication, serving as a leading cause of amputation, disability, hospitalisation and a significant contributor to healthcare costs. Deficiencies in vitamin C and other micronutrients are common in DFU. Emerging evidence suggests vitamin C supplementation may enhance wound healing; however, high-quality randomised controlled trials are lacking. Therefore, the aim of this study is to investigate the efficacy of oral vitamin C supplementation (1 g/day) for 8 weeks on wound healing in people with DFU. METHODS: This is a multi-site, parallel group, randomised, placebo-controlled, double-blind trial. Eighty adults with DFU will be recruited and randomly assigned to either placebo or vitamin C supplementation (500 mg twice daily). Ulcer measurements will be obtained at baseline, 2, 4, 6 and 8 weeks with all other measures collected at baseline and 8 weeks. The primary outcome measure is the percentage reduction in ulcer size (ulcer volume in mm3) at 8 weeks, compared to baseline. Secondary outcomes are changes in plasma vitamin C, time to 50% ulcer healing, time to complete ulcer healing, rate of healing of ulcers and adverse events. Exploratory outcomes include changes to glycaemic status, blood lipids, blood pressure, peripheral arterial perfusion, mental health and well-being, scurvy signs and symptoms and oxidative stress. DISCUSSION: The findings from this research will provide high-quality evidence on the e...