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
Michelle R. Kaminski, Eleanor Thong, Shaun Mason, Gavin Abbott, Chris Lemoh, Jennifer Wong, Paige van der Pligt, Zhong Lu, Janet Golder, Jeong Hyun Kwon, Glenn D. WadleyABSTRACT
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 mm 3 ) 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 efficacy of vitamin C for wound healing in people with DFU and help to inform clinical practice regarding vitamin C supplementation alongside current standard care to aid in the healing of DFUs.
Trial Registration
Australian and New Zealand Clinical Trials Registry (ACTRN12624000675527). Universal Trial Number (UTN) U1111‐1308‐1050