Table 1—

Details of discontinued patients

Center/ patient	Reason for discontinuation	Group	Ulcer location	Description	Severity	Relationship to treatment:
1/6	Serious AE	Control	Dorsal	Exposition of first metatarsal head	Severe	Unlikely
1/7	Serious AE	Control	Plantar	Phlegmon right foot	Severe	Unlikely
1/13	Serious AE	Control	Dorsal	Phlegmon	Severe	Unlikely
1/17	Serious AE	Control	Dorsal	Infection of dorsal ulcer left foot	Severe	Unlikely
1/37	Investigator decision	Control	Plantar	—	—	—
1/41	Serious AE	Control	Dorsal	Osteomielitis of fifth metatarsal right foot	Severe	Unlikely
1/18	Serious AE	Treated	Plantar	Phlegmon in region of the ulcer	Severe	Not clear
2/4	Serious AE	Treated	Dorsal	Fracture of the right femoral head	Severe	Unlikely
2/23	Serious AE	Treated	Dorsal	Restenosis after peripheral transcutaneous angioplasty	Moderate	Unlikely
2/3	Protocol violation	Control	Plantar	Patient did not attend the 77th-day visit	—	—
2/13	Protocol violation	Control	Dorsal	Patient did not attend two consecutive visits	—	—
2/19	Protocol violation	Control	Plantar	Patient did not attend two consecutive visits	—	—
2/21	Protocol violation	Control	Plantar	Area <1 cm² at baseline	—	—
2/14	Protocol violation	Treated	Dorsal	Patient did not attend two consecutive visits	—	—
2/16	Protocol violation	Treated	Dorsal	Patient did not attend two consecutive visits	—	—
2/18	Protocol violation	Treated	Dorsal	Area <1 cm² at baseline	—	—
2/9	Protocol violation	Treated	Plantar	Area <1 cm² at baseline	—	—
6/1	Protocol violation	Treated	Plantar	Patient did not attend the 77th-day visit	—	—

AE, adverse event.