Table 1 Study procedure schedule
Procedure | Visit 1 (week −2) | Visit 2 (week −1) | Visit 3 (week 0), randomization | Visits 4 to 10 (weeks 1 to 7), treatment (variable) | Visits 11 to 14 (weeks 8 to 11), treatment | Visit 15 (week 12), study endpoint | Visits 16 to 19 (weeks 13 to 28), follow-up |
|---|---|---|---|---|---|---|---|
Informed consent | X | ||||||
Inclusion/exclusion criteria | X | X | X | ||||
Physical examination | X | X | |||||
Vital signs | X | X | X | X | X | X | X |
Ankle-brachial index | X | ||||||
Fungal infection culture and malignancy evaluation | X | ||||||
Blood sample drawn for laboratories | X | X | |||||
SF-36v2™ questionnaire | X | X | |||||
Ulcer assessment | X | X | X | X | X | X | X |
Debridement | X | X | X | X | X | X | X |
Ulcer photography and area measurement | X | X | X | X | X | X | X |
Randomization | X | ||||||
Dermagraft® Tx + SOC | X | X | |||||
Oasis® Tx + SOC | X | X | |||||
SOC and off-loading | X | X | X | X | X | X | X |
Concomitant medications and adverse events | X | X | X | X | X | X | X |