Collings Richard, Freeman Jennifer, Latour Jos M, Hosking Joanne, Paton Joanne
Department of Podiatry, Torbay and South Devon NHS Foundation Trust, Torquay, UK.
School of Health Professions, Faculty of Health, University of Plymouth, Plymouth, UK.
Pilot Feasibility Stud. 2023 Feb 3;9(1):20. doi: 10.1186/s40814-023-01252-y.
Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimising plantar foot pressure reduction in people with diabetes has been developed.
To explore the feasibility and acceptability of testing an optimised insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.
A double-blinded multi-centre feasibility RCT with an embedded qualitative study. Participants were randomised to either an optimised insole group (intervention) or a standard cushioned insole group (active control). Participants were assessed at baseline, 3, 6, and 12 months with clinical outcomes of foot ulceration and mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analysed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).
Screened were142 patients from which 61 were recruited; 30 participants were randomised to the intervention group and 31 to the active control group. Forty-two participants completed the study. At 12 months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. There were 17 incidences of foot ulceration occurring in 7/31 of the active control group and 10/30 in the intervention group. Mean difference in MPPP between the intervention and active control groups for all regions-of-interest combined favoured the intervention. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation.
The results of the feasibility RCT suggest that the optimised insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy.
International Standard Randomised Controlled Trial Number: ISRCTN16011830 . Registered 9th October 2017.
治疗性鞋具和鞋垫是降低与糖尿病足溃疡风险相关的足底压力升高的预防策略。已经开发出一种适合床边使用的鞋垫干预措施，可优化糖尿病患者的足底压力降低效果。
探讨与活性对照鞋垫相比，测试优化鞋垫以降低糖尿病周围神经病变患者足底压力的可行性和可接受性。
一项双盲多中心可行性随机对照试验，并嵌入定性研究。参与者被随机分为优化鞋垫组（干预组）或标准缓冲鞋垫组（活性对照组）。在基线、3个月、6个月和12个月时对参与者进行评估，评估足部溃疡的临床结局和平均足底峰值压力（MPPP）降低情况。一项嵌入的定性研究包括对12名研究参与者和3名足病医生进行半结构化访谈，以探讨他们对干预措施和试验程序的体验。使用描述性统计（定量数据）和主题分析（定性数据）对数据进行分析。
共筛查了142名患者，其中61名被招募；30名参与者被随机分配到干预组，31名被分配到活性对照组。42名参与者完成了研究。在12个月时，69%的患者报告问卷被收回，68%的临床结局被收集。活性对照组31人中有7人发生17次足部溃疡，干预组30人中有10人发生。所有感兴趣区域的干预组和活性对照组之间MPPP的平均差异有利于干预组。主题分析揭示了三个主题：接受研究、研究过程中的行为和支持以及研究参与的影响。
可行性随机对照试验的结果表明，优化鞋垫作为一种干预措施具有前景，对于糖尿病周围神经病变患者，进行一项全面的随机对照试验以评估该干预措施的临床和成本效益是可行且有必要的。
国际标准随机对照试验编号：ISRCTN16011830。于2017年10月9日注册。
