Implications for a definitive study
Charcot neuroarthropathy
INFLAMMATION, HAND INFECTION, RECRUITMENT, ULCERATION
A definitive study on serial MRI in people with Charcot neuroarthropathy attending multidisciplinary foot clinics is justified and feasible, based on recruitment and retention rates, and acceptability of the intervention and study visit schedule to participants.In a future study randomisation should be stratified for the type of off-loading device. Normal plain X-rays, widespread inflammation, and participants awaiting their baseline MRI meant that it was sometimes difficult for investigators to classify the location of the Charcot neuroarthropathy at baseline. To address this missing data, we will modify the data collection tool to ask investigators to confirm or record the location of the Charcot neuroarthropathy at baseline and the 3 month follow-up visit. We found low levels of data completeness in the patient diary. Therefore, in a future study we will modify the patient diary and collect a more complete picture of participants’ costs. The diary will be co-produced with patient and public involvement to ensure the diary is relevant to and reflects the priorities of people with Charcot neuroarthropathy and other key stakeholders.Prior to any future definitive trial, we will undertake a Delphi consensus study to optimise and standardise the intervention serial MRI. Finally, we will seek to capture the reasons for any non-study MRIs.A continuation of the COVID-19 pandemic or another pandemic may disrupt a future study. To prepare for the possibility of this we will seek to maximise data collection through additional participant reported outcomes. This could include the type of off-loading device being used, self-monitored foot temperatures when participants are transferred from non-removable to removable devices to reduce the number of hospital appointments they need to attend, and outcomes such as ulceration and infection.If a future definitive study proves that MRI is a more effective way to monitor Charcot neuroarthropathy, then this could save healthcare providers money. People would regain their independence and go back to work sooner.