Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trialReport as inadecuate




Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:462

First Online: 26 November 2014Received: 07 July 2014Accepted: 11 November 2014DOI: 10.1186-1745-6215-15-462

Cite this article as: Jeffcoate, W., Game, F., Price, P. et al. Trials 2014 15: 462. doi:10.1186-1745-6215-15-462

Abstract

BackgroundUlcers 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-DesignThis 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 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.

DiscussionIf 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 numberISRCTN62524796 Registered 29 March 2011

KeywordsDiabetic foot ulcer Heel Pressure sore Ulcer healing Diabetes complications Neuropathy Casting Off-loading Amputation AbbreviationsABPIankle brachial pressure index

ADEadverse device effect

CIconfidence interval

CRFcase report form

CTUclinical trials unit

CWISCardiff Wound Impact Schedule

DMCData Monitoring Committee

EPUAPEuropean Pressure Ulcer Advisory Panel

EQ-5DEuroqol-5D

GCPGood clinical practice

ITTintention-to-treat

LRTLikelihood Ratio Test

MRCMedical Research Council

NHSNational Health Service

NICENational Institute for Clinical Excellence

NIHRNational Institute for Health Research

NPUAPNational Pressure Ulcer Advisory Panel

ORodds ratio

PPper protocol

QALYsQuality Adjusted Life Years

RCNRoyal College of Nursing

RECResearch Ethics Committee

SADEserious adverse device effect

SDstandard deviation

SPsafety population

TMGTrial Management Group

TSCTrial Steering Committee

VASvisual analogue scale

Download fulltext PDF



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

Source: https://link.springer.com/







Related documents