Screening Period | Treatment Period Weeks | Follow-Up Period Months | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening visit | Day 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | Month1 | Month2 | Month3 | |||
Informed Consent | X | ||||||||||||||||||
Inclusion Criteria | X | ||||||||||||||||||
Exclusion Criteria | X | ||||||||||||||||||
Randomisation | X | ||||||||||||||||||
Medical history | X | ||||||||||||||||||
Physical Examination | X | X | X | X | X | ||||||||||||||
Vital Signs | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Intercurrent Illness | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Intercurrent Medication | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Tolerability Assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
Target ulcer assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
SF 36 and CWIS | X | X | X | ||||||||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
Compression hosiery fitting/ application | X | X2 | |||||||||||||||||
Check for Ulcer Recurrence | X | X | X | ||||||||||||||||
Care of ulcer information sheet | X | X2 | X4 | X4 | X4 | ||||||||||||||
Referred back to specialty wound clinic | X3 | X4 | X4 | X4 |