drugset / Trial / NCT01849965
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aclerastide | Protein / enzyme biologic | 0.03 % | Topical |