Clinical efficacy, safety, and participant acceptability outcomes
Charcot neuroarthropathy
MINOR, REGRESSION, EVENTS, ULCERATIONS, COMPLICATIONS
All 30 participants with a confirmed diagnosis of Charcot neuroarthropathy were included in the Cox regression analysis hazard model. In this feasibility study 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), Results from Cox regression analysis on time in cast/off-loading device (days)One participant in the standard care plus arm was admitted to hospital because of foot complications; no minor or major amputations were reported. Thirty-eight ulcerations were recorded on 19 participants during the active phase, of which 12 were attributed to the off-loading device. Participants reported 84 falls, six required outpatient medical attention, and a further four hospital admissions. No safety events associated with the intervention (MRI) were reported. No participants declined an MRI or failed to attend their MRI imaging appointment.