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

Abstract Aim This 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 warrantedMethodsA 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 six months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness and safety of the intervention MRI. We also collected clinical, and patient reported outcomes, and data on health and social care usage to inform a future cost effectiveness analysis.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 Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made diagnosis. 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. As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. However, there was no statistical difference in the time in 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 registration ISRCTN, 74101606. Registered on 6 November 2017.http://www.isrctn.com/ISRCTN74101606?q=CADom&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search