Table 1—

Details of discontinued patients

Center/ patientReason for discontinuationGroupUlcer locationDescriptionSeverityRelationship to treatment:
1/6Serious AEControlDorsalExposition of first metatarsal headSevereUnlikely
1/7Serious AEControlPlantarPhlegmon right footSevereUnlikely
1/13Serious AEControlDorsalPhlegmonSevereUnlikely
1/17Serious AEControlDorsalInfection of dorsal ulcer left footSevereUnlikely
1/37Investigator decisionControlPlantar
1/41Serious AEControlDorsalOsteomielitis of fifth metatarsal right footSevereUnlikely
1/18Serious AETreatedPlantarPhlegmon in region of the ulcerSevereNot clear
2/4Serious AETreatedDorsalFracture of the right femoral headSevereUnlikely
2/23Serious AETreatedDorsalRestenosis after peripheral transcutaneous angioplastyModerateUnlikely
2/3Protocol violationControlPlantarPatient did not attend the 77th-day visit
2/13Protocol violationControlDorsalPatient did not attend two consecutive visits
2/19Protocol violationControlPlantarPatient did not attend two consecutive visits
2/21Protocol violationControlPlantarArea <1 cm2 at baseline
2/14Protocol violationTreatedDorsalPatient did not attend two consecutive visits
2/16Protocol violationTreatedDorsalPatient did not attend two consecutive visits
2/18Protocol violationTreatedDorsalArea <1 cm2 at baseline
2/9Protocol violationTreatedPlantarArea <1 cm2 at baseline
6/1Protocol violationTreatedPlantarPatient did not attend the 77th-day visit
  • AE, adverse event.