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

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

Trials, Volume: 15, Issue: 1

Swansea University Authors: Ceri Phillips, Tricia Price

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DOI (Published version): 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 ef...

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Published in: Trials
ISSN: 1745-6215
Published: 2014
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URI: https://cronfa.swan.ac.uk/Record/cronfa48703
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>48703</id><entry>2019-02-05</entry><title>Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial</title><swanseaauthors><author><sid>932c7a406ab4b6e4a881d422ca03c289</sid><firstname>Ceri</firstname><surname>Phillips</surname><name>Ceri Phillips</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>72b4943af96c97ef72977c31b9c29624</sid><firstname>Tricia</firstname><surname>Price</surname><name>Tricia Price</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2019-02-05</date><deptcode>FGMHL</deptcode><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 cm2) 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</abstract><type>Journal Article</type><journal>Trials</journal><volume>15</volume><journalNumber>1</journalNumber><paginationStart/><paginationEnd/><publisher/><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1745-6215</issnElectronic><keywords/><publishedDay>26</publishedDay><publishedMonth>11</publishedMonth><publishedYear>2014</publishedYear><publishedDate>2014-11-26</publishedDate><doi>10.1186/1745-6215-15-462</doi><url/><notes/><college>COLLEGE NANME</college><department>Medicine, Health and Life Science - Faculty</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>FGMHL</DepartmentCode><institution>Swansea University</institution><degreesponsorsfunders>HTA</degreesponsorsfunders><apcterm/><funders/><projectreference/><lastEdited>2023-06-28T15:29:09.0639002</lastEdited><Created>2019-02-05T16:17:00.9465026</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>William</firstname><surname>Jeffcoate</surname><order>1</order></author><author><firstname>Frances</firstname><surname>Game</surname><order>2</order></author><author><firstname>Patricia</firstname><surname>Price</surname><order>3</order></author><author><firstname>Ceri</firstname><surname>Phillips</surname><order>4</order></author><author><firstname>Vivienne</firstname><surname>Turtle-Savage</surname><order>5</order></author><author><firstname>Tricia</firstname><surname>Price</surname><order>6</order></author></authors><documents><document><filename>0048703-21022019100228.pdf</filename><originalFilename>48703.pdf</originalFilename><uploaded>2019-02-21T10:02:28.5100000</uploaded><type>Output</type><contentLength>384857</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2019-02-20T00:00:00.0000000</embargoDate><documentNotes>Released under the terms of a Creative Commons Attribution License (CC-BY).</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling v2 48703 2019-02-05 Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial 932c7a406ab4b6e4a881d422ca03c289 Ceri Phillips Ceri Phillips true false 72b4943af96c97ef72977c31b9c29624 Tricia Price Tricia Price true false 2019-02-05 FGMHL 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 cm2) 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 Journal Article Trials 15 1 1745-6215 26 11 2014 2014-11-26 10.1186/1745-6215-15-462 COLLEGE NANME Medicine, Health and Life Science - Faculty COLLEGE CODE FGMHL Swansea University HTA 2023-06-28T15:29:09.0639002 2019-02-05T16:17:00.9465026 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine William Jeffcoate 1 Frances Game 2 Patricia Price 3 Ceri Phillips 4 Vivienne Turtle-Savage 5 Tricia Price 6 0048703-21022019100228.pdf 48703.pdf 2019-02-21T10:02:28.5100000 Output 384857 application/pdf Version of Record true 2019-02-20T00:00:00.0000000 Released under the terms of a Creative Commons Attribution License (CC-BY). true eng
title Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
spellingShingle Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
Ceri Phillips
Tricia Price
title_short Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
title_full Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
title_fullStr Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
title_full_unstemmed Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
title_sort Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
author_id_str_mv 932c7a406ab4b6e4a881d422ca03c289
72b4943af96c97ef72977c31b9c29624
author_id_fullname_str_mv 932c7a406ab4b6e4a881d422ca03c289_***_Ceri Phillips
72b4943af96c97ef72977c31b9c29624_***_Tricia Price
author Ceri Phillips
Tricia Price
author2 William Jeffcoate
Frances Game
Patricia Price
Ceri Phillips
Vivienne Turtle-Savage
Tricia Price
format Journal article
container_title Trials
container_volume 15
container_issue 1
publishDate 2014
institution Swansea University
issn 1745-6215
doi_str_mv 10.1186/1745-6215-15-462
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description 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 cm2) 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
published_date 2014-11-26T15:29:05Z
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