Study procedure | Set up (Visit 1) | Baseline/Study Day 0 (Visit 2) | Study Day 1 (the day after consent) | Upon new injury | Weekly* for 16 weeks | Study Day 112 | Qualitative data collection |
---|---|---|---|---|---|---|---|
Identify potentially eligible participants | X | ||||||
Provide Participant Information Sheet | X | ||||||
Informed consent | X | ||||||
Collection of baseline information | X | ||||||
EQ5D-5 L questionnaire | X | Xc | X | ||||
ICECAP-O questionnaire | X | Xc | X | ||||
FES-I (short) questionnaire | X | Xc | X | ||||
Randomisation | X | ||||||
Provision of socks (intervention arm only) | X | ||||||
Wearing of socks (intervention arm only) | X --------------------------------- > X | ||||||
Completion of participant diary (intervention arm only) | X --------------------------------- > X | ||||||
Photograph wound | Xb | ||||||
Measurement of wound | Xb | ||||||
Wound scoring | Xb | ||||||
Cardiff wound impact schedulea | Xc | Xd | |||||
Adverse event recording | X --------------------------------- > Xe | ||||||
Research nurse to visit care home for progress checks | X | ||||||
Patient interviews | X | ||||||
Focus groups | X |