At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds
In Brief
A Phase 4 clinical trial evaluating Santyl and Control for Diabetic Foot Ulcers and Diabetic Foot Wounds. Completed, enrolled 55 participants across 7 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
2 mm Santyl applied once daily
Standard Care