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.

IF 2.3 3区医学 Q1 ORTHOPEDICS

Journal of Foot and Ankle Research Pub Date : 2026-09-01 DOI:10.1002/jfa2.70193

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 Wadley

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引用次数: 0

Abstract

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 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.

查看原文本刊更多论文

维生素C治疗有助于糖尿病患者足部溃疡愈合的疗效：一项随机、安慰剂对照双盲试验：Foot -C研究方案

导言：糖尿病相关性足部溃疡（DFU）是一种严重的并发症，是截肢、残疾、住院的主要原因，也是医疗费用的重要贡献者。缺乏维生素C和其他微量营养素在DFU中很常见。新出现的证据表明，补充维生素C可以促进伤口愈合；然而，缺乏高质量的随机对照试验。因此，本研究的目的是研究口服维生素C补充（1 g/天）8周对DFU患者伤口愈合的疗效。方法：这是一项多地点、平行组、随机、安慰剂对照、双盲试验。将招募80名患有DFU的成年人，随机分配安慰剂组或维生素C补充组（每天两次，500毫克）。将在基线、2周、4周、6周和8周获得溃疡测量值，所有其他测量值在基线和8周收集。主要结局指标是与基线相比，8周时溃疡大小（以mm3为单位的溃疡体积）减少的百分比。次要结局是血浆维生素C的变化、溃疡愈合至50%的时间、溃疡完全愈合的时间、溃疡愈合率和不良事件。探索性结果包括血糖状态、血脂、血压、外周动脉灌注、精神健康和幸福感、坏血病体征和症状以及氧化应激的变化。讨论：本研究的结果将为维生素C对DFU患者伤口愈合的疗效提供高质量的证据，并有助于为临床实践提供有关维生素C补充和当前标准护理以帮助DFU愈合的信息。试验注册：澳大利亚和新西兰临床试验注册中心（ACTRN12624000675527）。通用试验号（UTN） U1111-1308-1050。

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来源期刊

Journal of Foot and Ankle Research ORTHOPEDICS-

CiteScore

4.50

自引率

10.30%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Foot and Ankle Research, the official journal of the Australian Podiatry Association and The College of Podiatry (UK), is an open access journal that encompasses all aspects of policy, organisation, delivery and clinical practice related to the assessment, diagnosis, prevention and management of foot and ankle disorders. Journal of Foot and Ankle Research covers a wide range of clinical subject areas, including diabetology, paediatrics, sports medicine, gerontology and geriatrics, foot surgery, physical therapy, dermatology, wound management, radiology, biomechanics and bioengineering, orthotics and prosthetics, as well the broad areas of epidemiology, policy, organisation and delivery of services related to foot and ankle care. The journal encourages submissions from all health professionals who manage lower limb conditions, including podiatrists, nurses, physical therapists and physiotherapists, orthopaedists, manual therapists, medical specialists and general medical practitioners, as well as health service researchers concerned with foot and ankle care. The Australian Podiatry Association and the College of Podiatry (UK) have reserve funds to cover the article-processing charge for manuscripts submitted by its members. Society members can email the appropriate contact at Australian Podiatry Association or The College of Podiatry to obtain the corresponding code to enter on submission.