School of Health Professions Faculty of Health and Human Sciences, University of Plymouth, Plymouth, UK.
Podiatry, Torbay and South Devon NHS Foundation Trust, Torquay, UK.
BMJ Open. 2019 Mar 23;9(3):e029185. doi: 10.1136/bmjopen-2019-029185.
Foot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.
This study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.
This study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.
The study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.
ISRCTN16011830; Pre-results.
足部溃疡是糖尿病的一种多因素并发症。治疗鞋垫和鞋子通常用于降低与足部溃疡风险相关的组织压力升高。已经开发出一种使用鞋内压力测量技术的新方案，以提供即时优化的鞋垫和室内鞋解决方案，旨在减少足部溃疡。
本研究旨在评估进行多中心随机对照试验的可行性，以比较新型即时优化鞋垫与糖尿病神经病变患者标准鞋垫的有效性。
这是一项参与者和评估者盲法、随机、多中心平行组可行性试验，嵌入定性研究。将从三个足病诊所招募 76 名参与者，并使用随机化程序通过研究中心和既往溃疡状况进行随机分组，分为优化鞋垫加常规护理（干预组）或标准鞋垫加常规护理（对照组）。评估访问和数据收集将在基线、3 个月、6 个月和 12 个月进行。将根据招募和保留率、数据完成率、干预依从性和盲法效果来确定试验程序的可行性和可接受性。对适当性和结果测量性能的评估将为主要和次要结果以及预期的确定性随机对照试验的样本量估计提供信息。临床结果包括足底溃疡的发生率和足底压力峰值的变化。将对 12 名参与者（每个中心 4 名）和 3 名治疗足病医生（每个中心 1 名）进行访谈，以探讨他们接受和提供干预的经验。
该研究已获得西南埃克塞特研究伦理委员会的批准。研究结果将通过会议演讲、公共平台和学术出版物进行传播。
ISRCTN86034063；预结果。
