Diabetic Foot Ulcers Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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