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