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A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound. This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.
Details
| Lead sponsor | Healthpoint |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 55 |
| Start date | 2011-08 |
| Completion | 2013-03 |
Conditions
- Diabetic Foot Ulcers
- Diabetic Foot Wounds
Interventions
- Santyl
- Control
Primary outcomes
- Mean Percent Change in Wound Area — 6 and 12 weeks
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Countries
United States