drugset / Trial / NCT01830348

Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

NCT01830348 ↗

Phase 3 Terminated 266 enrolled Integra LifeSciences Corporation Integrium · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.

Timeline

Start
2013-02
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aclerastide Protein / enzyme biologic 0.03 % Topical

Indications