Periods | Enrollment/screening | Allocation | Active treatment | Follow-up/close-out | |||
---|---|---|---|---|---|---|---|
Visits | Visit 1 | Visit 2 | Visit 3 to visit 13 | 14 (EOT) | 15 | 16 | 17 |
Days from randomization visit | Days -14 to -28 (prior to active treatment) | Day 0 | Day 1 to day 28 | Day 30 (± 5 days) | Day 44 (± 2 days) | Day 56 (± 2 days) | Day 84 (± 5 days) |
Enrollment | |||||||
Informed consent | X | ||||||
Inclusion/exclusion criteria | X | X | |||||
Demography | X | ||||||
Medical history | X | ||||||
Concomitant medication | X | X | X | X | X | X | X |
Interventions | |||||||
Randomization | X | ||||||
IMP application (verum) | X | X | |||||
IMP application (placebo) | X | X | |||||
Assessments | |||||||
Physical examination and vital signs | X | X | X | X | |||
Hematologya | X | X | |||||
Serum chemistryb | X | X | |||||
Urine analysisc | X | X | |||||
Urine pregnancy test | X | X | X | ||||
Wound assessment | X | X | X | X | X | X | X |
Assessment of wound closure | X | X | X | X | X | X | X |
Wound size measurement (eKare inSight®) | X | X | X | X | X | X | X |
Standard of care for wound management | X | X | X | X | X | X | X |
VAS—score for pain | X | X | X | X | X | X | X |
Neurological assessment foot | X | X | X | ||||
Chronic wound quality of life questionnaire | X | X | X | ||||
Recording adverse events | X | X | X | X | X | X |