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.