Table 1 VenUS 6 SPIRIT figure
Enrolment | Allocation | Clinical assessments | Postal questionnaires | GP check | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
Timepoint | Pre-randomisation/baseline | Randomisation | Participant visit log (weekly) | Participant events form (monthly and when required) | Telephone calls (monthly) | 1 mon | 3 mon | 6 mon | 12 mon | |
Enrolment | ||||||||||
Eligibility screen | ✓ | |||||||||
Informed consent | ✓ | |||||||||
Baseline data | ✓ | |||||||||
Allocation | ✓ | |||||||||
Staff collected | ||||||||||
Wound Healing | ✓ | ✓ | ✓ | |||||||
Changes to treatment | ✓ | |||||||||
Other clinical events | ✓a | ✓ | ✓ | |||||||
Adverse events | ✓ | ✓ | ✓ | |||||||
Confirmation of death | ✓ | ✓ | ✓ | |||||||
Participant-reported | ||||||||||
HRQOL, | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
Resource use | ✓ | ✓ | ✓ | |||||||
Wound-related pain; participant adherence; ease of treatment use | ✓ | ✓ | ✓ | ✓ | ||||||