Feasibility outcomes | Clinical efficacy outcomes Collected – all study visits | Patient reported outcomes Collected – baseline, 3 monthly until remission, then at 1 and 6-months post remission |
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The proportion of patients who meet the eligibility criteria | Time in cast/off-loading device | Health related quality of life measured: • SF-12 [18] • EQ-5D-5L [19], analysed using the crosswalk methodology [20] |
The number of eligible participants recruited | Number of new ulcerations on the index foot | HADS [21] |
The number of participants in which an alternative diagnosis is made during the active phase of the study | Number of new ulcerations on the index or contralateral foot | VAS |
The proportion of participants that withdraw or are lost to follow up. The term ‘withdrawal’ encompasses two potential scenarios: withdrawal due to loss of consent or withdrawal due to death | Number of new infections on the index or contralateral foot | Data on health and social care usage- Patient Diary |
• Change in employment • Frequency and the amount of time participants received help with personal and household tasks • Number of all healthcare appointments • Number and severity of falls (Hopkins Fall Grading System) [22] | ||
Statistical parameters of the key outcome measures to inform a sample size calculation for a definitive study | Number of minor and major amputations on the index foot or contralateral foot at the end of the follow up phase of the study |  |
Safety of the intervention (MRI). | The number of participants in each arm requiring further intervention for Charcot (e.g., further immobilisation) within 6 months of remission |  |
Data completeness and adherence to study procedures | Â | Â |
Participant acceptability of MRI - the number of MRIs declined or not attended by participants | Â | Â |