Table 1 Schedule of activities

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