{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T14:44:18Z","timestamp":1789656258931,"version":"4.0.1"},"reference-count":33,"publisher":"National Institute for Health and Care Research","issue":"34","license":[{"start":{"date-parts":[[2017,5,1]],"date-time":"2017-05-01T00:00:00Z","timestamp":1493596800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["09\/01\/53"],"award-info":[{"award-number":["09\/01\/53"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\">\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-2\">\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-3\">\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-4\">\n                  <jats:title>Setting<\/jats:title>\n                  <jats:p>Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged \u2265\u200918 years and had diabetes mellitus complicated by ulcers of the heel of grades 2\u20134 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-5\">\n                  <jats:title>Participants<\/jats:title>\n                  <jats:p>In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1\u2009:\u20091 to the intervention (<jats:italic>n<\/jats:italic>\u2009=\u2009256) or the control (<jats:italic>n<\/jats:italic>\u2009=\u2009253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275\u2009mm<jats:sup>2<\/jats:sup> [interquartile range (IQR) 104\u2013683\u2009mm<jats:sup>2<\/jats:sup>] in the intervention group and 206\u2009mm<jats:sup>2<\/jats:sup> (IQR 77\u2013649\u2009mm<jats:sup>2<\/jats:sup>) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-6\">\n                  <jats:title>Interventions<\/jats:title>\n                  <jats:p>The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant\u2019s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-7\">\n                  <jats:title>Main outcome measures<\/jats:title>\n                  <jats:p>The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-8\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Forty-four per cent (<jats:italic>n<\/jats:italic>\u2009=\u200994) of the intervention group healed within 24 weeks, compared with 37% (<jats:italic>n<\/jats:italic>\u2009=\u200980) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; <jats:italic>p<\/jats:italic>\u2009=\u20090.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-9\">\n                  <jats:title>Limitations<\/jats:title>\n                  <jats:p>Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-10\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-11\">\n                  <jats:title>Future work<\/jats:title>\n                  <jats:p>It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-12\">\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>Current Controlled Trials ISRCTN62524796.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"abs1-13\">\n                  <jats:title>Funding<\/jats:title>\n                  <jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in <jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.<\/jats:p>\n               <\/jats:sec>","DOI":"10.3310\/hta21340","type":"journal-article","created":{"date-parts":[[2017,6,23]],"date-time":"2017-06-23T12:57:16Z","timestamp":1498222636000},"page":"1-92","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial"],"prefix":"10.3310","volume":"21","clinical-trial-number":[{"clinical-trial-number":"isrctn62524796","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"William","family":"Jeffcoate","sequence":"first","affiliation":[{"name":"Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Game","sequence":"additional","affiliation":[{"name":"Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK"},{"name":"Diabetes and Endocrinology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivienne","family":"Turtle-Savage","sequence":"additional","affiliation":[{"name":"Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Musgrove","sequence":"additional","affiliation":[{"name":"Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Price","sequence":"additional","affiliation":[{"name":"Vice-Chancellor\u2019s Office, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Tan","sequence":"additional","affiliation":[{"name":"Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Bradshaw","sequence":"additional","affiliation":[{"name":"Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Montgomery","sequence":"additional","affiliation":[{"name":"Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Fitzsimmons","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, College of Human and Health Science, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Farr","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, College of Human and Health Science, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Winfield","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, College of Human and Health Science, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ceri","family":"Phillips","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, College of Human and Health Science, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2017,5]]},"reference":[{"key":"key20170601132312686_ref1-bib1","doi-asserted-by":"publisher","first-page":"462","DOI":"10.1186\/1745-6215-15-462","article-title":"Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial","volume":"15","author":"Jeffcoate","year":"2014","journal-title":"Trials"},{"key":"key20170601132312686_ref1-bib2","doi-asserted-by":"crossref","first-page":"1719","DOI":"10.1016\/S0140-6736(05)67698-2","article-title":"The global burden of diabetic foot disease","volume":"366","author":"Boulton","year":"2005","journal-title":"Lancet"},{"key":"key20170601132312686_ref1-bib3","doi-asserted-by":"crossref","first-page":"855","DOI":"10.2337\/diacare.21.5.855","article-title":"Validation of a diabetic wound classification system. 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