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A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
Details
| Lead sponsor | Healthpoint |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 57 |
| Start date | 2010-06 |
| Completion | 2012-10 |
Conditions
- Diabetic Foot Ulcers
Interventions
- Santyl
- White Petrolatum
Primary outcomes
- Change in Wound Area — 4 Weeks
The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period
Countries
United States