Gooday Catherine, Game Frances, Woodburn Jim, Poland Fiona, Sims Erika, Dhatariya Ketan, Shepstone Lee, Hardeman Wendy
School of Health Sciences, University of East Anglia, Norwich, NR4 7TJ UK.
Elsie Bertram Diabetes Centre, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, NR4 7UY UK.
Pilot Feasibility Stud. 2020 Jun 16;6:85. doi: 10.1186/s40814-020-00611-3. eCollection 2020.
Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than 1 year. Small observational studies suggest that repeated assessment with magnetic resonance imaging improves decision-making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial magnetic resonance imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants' lived experience of Charcot neuroarthropathy and of taking part in the feasibility study.
We will undertake a two-arm, open study and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive magnetic resonance imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient-centred and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10-14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis.
The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient-centred strategies.
ISRCTN, ISRCTN74101606. Registered on 6 November 2017.
夏科氏神经关节病是糖尿病相关周围神经病变的一种并发症，最常累及下肢。它可导致足部骨折和脱位，并可能发展为畸形和溃疡。推荐的治疗方法是固定和减轻负重，使用不可拆卸的膝下石膏或靴子。治疗持续时间从六个月到一年以上不等。小型观察性研究表明，磁共振成像反复评估有助于改善关于何时停止治疗的决策，但这尚未在临床试验中得到验证。本研究旨在探讨在不使用造影剂的情况下，利用系列磁共振成像监测夏科氏神经关节病以缩短足部固定时间的可行性。一项嵌套式定性研究旨在探索参与者患夏科氏神经关节病的生活经历以及参与可行性研究的体验。
我们将开展一项双臂开放性研究，从英格兰五个国民保健服务（NHS）二级护理多学科糖尿病足诊所中随机选取60名疑似或确诊为夏科氏神经关节病的患者。参与者将按1:1随机分组，一组在基线和缓解期（最长12个月）接受磁共振成像检查，并重复测量足部温度和进行X线检查（标准护理加），另一组在标准护理加的基础上每三个月额外进行一次磁共振成像检查直至缓解期（最长12个月）（干预组）。夏科氏神经关节病通过减负治疗确认缓解的时间（天数）及其方差将用于确定全面试验的样本量。我们将寻找机会改进监测技术方案以及未来研究中使用的临床、以患者为中心和卫生经济学测量方法。对于嵌套式定性研究，我们将邀请10 - 14名能够提供可行性研究中最大程度不同体验的目标样本参与半结构化访谈，并采用主题分析法进行分析。
该研究将为是否进行全面试验提供决策依据。它还将使我们更深入地了解夏科氏神经关节病的生活经历，以及有助于参与管理和有助于制定更有效的以患者为中心策略的因素。
国际标准随机对照试验编号（ISRCTN），ISRCTN74101606。于2017年11月6日注册。
