PROTOCOL ACTIVITIES | Screening Visit | Initial Visit | Treatment visits | Follow-up visits | |||
---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | ||||
SCHEDULE OF VISITS | 0 | 1–20 | 21+3 | 45 ± 7 | 90 ± 14 | 180 ± 14 | |
Clinical History | X | X | X | X | X | X | |
Physical Examination | X | X | X | X | X | X | |
Inclusion/Exclusion criteria | X | ||||||
Informed Consent | X | ||||||
Direct test | X | ||||||
Sampling of cultures | X | ||||||
Laboratory tests | X | X | |||||
Randomization | X | ||||||
Treatment administration | X | X | |||||
Clinical assessment of the lesion | X | X | X | X | X | X | X |
Measurement of ulcers | X | X | X | X | X | ||
Photographic registration | X | X | X | X | X | ||
Education of patients | X | X | X | X | X | X | X |
Handing over of diary | X | ||||||
Evaluation of effectiveness | X | X | X | X | |||
Documentation of adverse events | X | X | X | X | X | X | X |
Recording of concomitant medications | X | X | X | X | X | X | X |