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.

BACKGROUND: 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. OBJECTIVE: To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. DESIGN: 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. SETTING: Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2-4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. PARTICIPANTS: 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 : 1 to the intervention (n = 256) or the control (n = 253) 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 mm2 [interquartile range (IQR) 104-683 mm2] in the intervention group and 206 mm2 (IQR 77-649 mm2) 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. INTERVENTIONS: 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's 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. MAIN OUTCOME MEASURES: 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). RESULTS: Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. LIMITATIONS: 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. CONCLUSIONS: 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. FUTURE WORK: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN62524796. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.

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

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.