Table 1

Schedule of activities

Follow-up visits
PROTOCOL ACTIVITIES
 Screening Visit
 Initial Visit
 Visit 1
 Visit 2
 Visit 3
 Visit 4
 Visit 5
 Final Visit
SCHEDULE OF VISITS
0
 15 ± 5
 30 ± 5
 45 ± 5
 60 ± 5
 75 ± 5
 90 ± 5
Clinical History
 X
 X
 X
 X
 X
 X
 X
 X
Physical Examination
 X
 X
 X
 X
 X
 X
 X
 X
Inclusion/Exclusion criteria
 X






Informed Consent
 X






Clinical assessment of vascular compromise
 X
 X
 X
 X
 X
 X
 X
 X
Clinical assessment of neuropathic compromise
X




X
Laboratory tests
X




X
Ankle/arm index
 X






Randomization
X





Treatment administration
X
 X
 X
 X
 X
 X
Clinical assessment of the lesion
 X
 X
 X
 X
 X
 X
 X
 X
Measurement of ulcers
 X
 X
 X
 X
 X
 X
 X
 X
Photographic registration
X
 X
 X
 X
 X
 X
 X
Education of patients
 X
 X
 X
 X
 X
 X
 X
 X
Documentation of adverse events
 X
 X
 X
 X
 X
 X
 X
 X
Recording of concomitant medications
 X
 X
 X
 X
 X
 X
 X
 X

Silva et al. Trials 2007 8:26   doi:10.1186/1745-6215-8-26