Discussion
diabetes, Charcot neuroarthropathy
HAND INFECTION, RECRUITMENT, ULCERATION, REGRESSION, DIABETES
This feasibility study recruited 43 participants with a suspected or confirmed Charcot neuroarthropathy diagnosis. Despite not achieving the recruitment target of 60 participants, and study interruptions due to the COVID-19 pandemic, our sample size was sufficiently large enough to draw conclusions about the feasibility of a definitive trial.Our participants were representative of the wider Charcot neuroarthropathy population, with more men, being in their fifth decade, and diabetes duration >10 years [Two-thirds of eligible participants agreed to take part. We recruited similar participant numbers to observational studies on monitoring techniques [Two-thirds of participants had an Eichenholtz Classification stage 0 at baseline with no changes on X-ray. This highlights the need to use MRI as an adjunct to X-rays in Charcot neuroarthropathy diagnosis and monitoring. Excluding the effect of COVID-19 pandemic on MRIs, 84% of intervention MRIs were completed, and no safety incidents reported. No participants declined an MRI. This supports the feasibility, safety, and participants’ acceptability of serial MRIs.Participants experienced multiple episodes of concurrent ulceration and infection. This highlights the previously recognised limitations of using infra-red thermography to monitor Charcot neuroarthropathy. If similar findings were replicated in a definitive trial this further justifies the need to use MRI as a monitoring technique for Charcot neuroarthropathy.The signal from this feasibility study does suggest that MRI may extend the time in cast/off-loading device. However, this feasibility study was not powered to detect a difference between the two arms of the study. As this was not an effectiveness study, the observed trend may change in an adequately powered definitive trial. The COVID-19 pandemic changed clinical practice, and reduced adherence to study procedures. We do not know how these changes affected the proposed primary outcome. Therefore, at this stage uncertainty remains and the trial is warranted as the sample size cannot exclude the possibility of a worthwhile effect.Disruption caused by the COVID-19 pandemic resulted in participants being transferred from non-removable to removable devices, reduced data collection, and intervention completeness. This means that the planned modified ITT Cox regression analysis cannot be relied upon to calculate an accurate simple size. We plan to re-analyse the data using a per protocol analysis to mitigate for the impact of the COVID-19 pandemic. We will also review the literature and use a focus group to work with patient and public involvement, healthcare professionals, and statisticians to agree the minimally important clinical difference for a reduction in ‘time in cast’. This information will then be used in a future sample size calculation.The results related to patient-reported outcomes need to be interpreted with caution: this is a feasibility study not powered to detect between-group or longitudinal differences. We showed that receiving treatment for Charcot neuroarthropathy has physical, emotional, and socioeconomic ramifications and are results are consistent with others [