Jeffcoate William, Game Frances, Turtle-Savage Vivienne, Musgrove Alison, Price Patricia, Tan Wei, Bradshaw Lucy, Montgomery Alan, Fitzsimmons Deborah, Farr Angela, Winfield Thomas, Phillips Ceri
Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK.
Diabetes and Endocrinology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.
Health Technol Assess. 2017 May;21(34):1-92. doi: 10.3310/hta21340.
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.
To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers.
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.
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.
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 ( = 256) or the control ( = 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 mm [interquartile range (IQR) 104-683 mm] in the intervention group and 206 mm (IQR 77-649 mm) 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.
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.
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).
Forty-four per cent ( = 94) of the intervention group healed within 24 weeks, compared with 37% ( = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome.
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.
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.
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.
Current Controlled Trials ISRCTN62524796.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.
糖尿病患者足部溃疡愈合缓慢，会导致高昂费用并使患者遭受痛苦。足跟溃疡的预后最差。
评估轻质玻璃纤维石膏在足跟溃疡治疗中的临床疗效和成本效益。
一项实用、多中心、平行、观察者盲法随机对照试验。一个中央随机化中心使用计算机生成的随机数字序列将参与者分配到各个组。
英国35个专科糖尿病足二级护理中心。招募的患者年龄≥18岁，患有糖尿病且合并有根据国家压力性溃疡咨询小组和欧洲压力性溃疡咨询小组量表评定为2 - 4级的足跟溃疡。
总共509名参与者[68%为男性，15%患有1型糖尿病，平均年龄67.5岁（标准差12.4岁）]被1∶1随机分配至干预组（n = 256）或对照组（n = 253）。425名参与者（干预组212名，对照组213名）可获得主要结局数据，且超出了所需总数；失访率为16.5%。干预组基线时溃疡面积中位数为275 mm²[四分位间距（IQR）104 - 683 mm²]，对照组为206 mm²（IQR 77 - 649 mm²）。两组在基线时任何参数上均无差异，无论是与参与者相关还是与他们的溃疡相关。
干预组接受常规护理，并额外加用一个定制的轻质玻璃纤维足跟石膏。对照组仅接受常规护理。干预阶段持续至参与者的溃疡愈合（维持28天）或24周，以先发生者为准。在此干预阶段，每2周对参与者进行一次复查，当玻璃纤维石膏无法再使用时进行更换。
主要结局指标是24周内溃疡愈合（由盲法观察者确认并维持4周）。其他结局指标包括溃疡愈合所需时间、横截面积减少百分比、局部疼痛减轻情况、截肢、生存率及卫生经济学分析。该研究的检验效能设定为确定愈合差异为15%（干预组55% vs. 对照组40%）。
采用意向性分析，干预组44%（n = 94）在24周内愈合，而对照组为37%（n = 80）（比值比1.42，95%置信区间0.95至2.14；P = 0.088）。两组在任何次要结局方面均未观察到差异。
尽管护理的组成项目是标准化的，但由于这是一项实用试验，常规护理并不统一。有证据表明干预组不良事件略有增加；然而，非盲法观察者记录了这些事件。未出现过多的器械不良影响。
使用足跟石膏可能会使愈合略有增加，但该估计不够精确，无法提供有力的疗效证据。没有证据表明干预在任何亚组中特别有效。卫生经济学分析表明，该干预不太可能具有成本效益。提供轻质足跟石膏可能对某些个体有益，但我们未找到证据证明在临床实践中常规采用它是合理的。
对该干预措施的进一步研究不太可能对常规临床护理产生影响，因此未来的努力应针对旨在改善该人群溃疡愈合的其他干预措施。
当前受控试验ISRCTN62524796。
该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，并将在《》第21卷第34期全文发表。有关该项目的更多信息，请访问NIHR期刊图书馆网站。
