drugset / Trial / NCT01849965

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

NCT01849965 ↗

Phase 3 Terminated 396 enrolled Integra LifeSciences Corporation Integrium · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

Timeline

Start
2013-04
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aclerastide Protein / enzyme biologic 0.03 % Topical

Indications