A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM)

Journal of Foot and Ankle Research

Research

Frances Game¹  Ketan Dhatariya²  Fiona Poland³  Erika Sims⁴  Garry Barton⁵  Lee Shepstone⁵  Wendy Hardeman⁶  Jim Woodburn⁷  Catherine Gooday⁸ 

[1] Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, DE22 3NE, Derby, UK;Elsie Bertram Diabetes Centre, Norfolk & Norwich University Hospitals NHS Foundation Trust, NR4 7UY, Norwich, UK;Norwich Medical School, University of East Anglia, NR4 7TJ, Norwich, UK;Institute for Volunteering Research, Faculty of Medicine and Health Science, University of East Anglia, NR4 7TJ, Norwich, UK;Norwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, NR4 7TJ, Norwich, UK;Norwich Medical School, University of East Anglia, NR4 7TJ, Norwich, UK;School of Health Sciences - Behavioural and Implementation Science Group, Faculty of Medicine and Health Sciences, University of East Anglia, NR4 7TJ, Norwich, UK;School of Health Sciences and Social Work, Griffith University, QLD 4222, Southport, Australia;School of Health Sciences, University of East Anglia, NR4 7TJ, Norwich, UK;Elsie Bertram Diabetes Centre, Norfolk & Norwich University Hospitals NHS Foundation Trust, NR4 7UY, Norwich, UK;

关键词: Charcot neuroarthropathy;    Remission;    Diabetes;    MRI;    Temperature monitoring;    X-ray;    Feasibility study;   

DOI  :  10.1186/s13047-023-00601-7

 received in 2022-07-22, accepted in 2023-01-04,  发布年份 2023

来源: Springer

【 摘 要 】

AimThis study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted.MethodsA multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to ‘standard care plus’, including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage.ResultsOne-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI.As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140–1.172), p = 0.096.DiscussionThe findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible.Study registrationISRCTN, 74101606. Registered on 6 November 2017.

【 授权许可】

CC BY   
© The Author(s) 2023

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