Table 2.

Feasibility, clinical efficacy and patient centred outcomes

Feasibility outcomes	Clinical efficacy outcomes (collected at all study visit)	Patient centred outcomes (collected at baseline, 3 monthly until remission, then at 1 and 6 months post remission)
The proportion of patients who meet the eligibility criteria	Number of new ulcerations on the index or contralateral foot	Health-related quality of life measured: Short Form 12 questionnaire (SF-12) [40] EuroQol-5D-5 L questionnaire (EQ-5D-5 L) [41]
The number of eligible patients recruited	Number of new infections on the index or contralateral foot	Hospital Anxiety and Depression Scale (HADS) [42]
The number of participants in which an alternative diagnosis is made during the active phase of the trial	Number of minor and major amputations on the index or contralateral foot at the end of the follow-up phase of the study	Pain as assessed by Visual Analogue Scale (VAS)
The proportion of patients 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 deaths	Number and severity of falls (Hopkins Fall Grading System) [43]	Patient diary
Statistical parameters of the key outcome measures, duration in off-loading  to inform a sample size calculation for a definitive trial	The number of participants in each arm requiring further intervention for CN (e.g. further immobilisation) within 6 months of remission
Ability to collect quality of life and resource use data