轻质玻璃纤维足跟支具在糖尿病足跟溃疡治疗中的评估：一项随机对照试验的研究方案

Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial.

作者信息

Jeffcoate William, Game Frances, Price Patricia, Phillips Ceri, Turtle-Savage Vivienne

机构信息

Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, City Hospital Campus, Hucknall Road, Nottingham, NG5 1 PB, UK.

出版信息

Trials. 2014 Nov 26;15:462. doi: 10.1186/1745-6215-15-462.

DOI:10.1186/1745-6215-15-462

PMID:25428268

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4289201/

Abstract

BACKGROUND

Ulcers of the heel in diabetes are the source of considerable suffering and cost. In the absence of specific treatments, it has been suggested that removable, lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain. The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers.

METHODS/DESIGN: This is an observer-blind, randomised controlled trial in which participants with diabetes and heel ulcers (NPUAP/EPUAP grades 2, 3 or 4 and present for 2 or more weeks) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone. Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form, and is stratified by both ulcer area (less than versus equal to or greater than 1 cm(2)) and NPUAP/EPUAP grade. Participants are followed every two weeks until healing or for 24 weeks. The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks. Secondary outcomes include (i) ulcer-related outcomes: time to healing, change in ulcer area, minor and major amputation, secondary infection and (ii) patient-related outcomes: local pain, mood and function (EQ-5D), impact of the ulcer (Cardiff Wound Impact Schedule) and survival. Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes, including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects.

DISCUSSION

If it is possible to confirm significant clinical benefit and/or cost-effectiveness, this would have direct implications for the management of this distressing and costly complication of diabetes

TRIAL REGISTRATION NUMBER

ISRCTN62524796 Registered 29 March 2011.

摘要

背景

糖尿病患者足跟溃疡会带来巨大痛苦并产生高昂费用。在缺乏特效治疗方法的情况下，有人提出可移除的轻质玻璃纤维足跟支具可能有助于促进愈合，并减轻不适与疼痛。本研究旨在评估玻璃纤维足跟支具治疗足跟溃疡的有效性及成本效益。

方法/设计：这是一项观察者盲法随机对照试验，患有糖尿病且足跟溃疡（NPUAP/EPUAP分级为2、3或4级且病程达2周或更长时间）的参与者被随机分为两组，一组接受常规护理加轻质玻璃纤维足跟支具，另一组仅接受常规护理。随机分组通过作为电子病历表单一部分的随机数字序列生成进行，并按溃疡面积（小于1平方厘米与等于或大于1平方厘米）和NPUAP/EPUAP分级进行分层。每两周对参与者进行随访，直至愈合或满24周。主要结局指标是在24周及之前愈合并维持4周。次要结局包括：（i）与溃疡相关的结局：愈合时间、溃疡面积变化、小截肢和大截肢、继发感染；（ii）与患者相关的结局：局部疼痛、情绪和功能（EQ - 5D）、溃疡影响（加的夫伤口影响量表）和生存率。将使用决策分析模型从英国国民健康服务体系及个人社会服务和健康结局的角度评估成本效益，包括愈合百分比和获得的质量调整生命年。安全性将记录为不良和严重不良器械效应。