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 | Â | Â |