NCT01408277

Using Santyl on Diabetic Foot Ulcers

A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers
• Diabetic Foot Wounds

Interventions

Type	Name	Description
BIOLOGICAL	Santyl	2 mm Santyl applied once daily
PROCEDURE	Control	Standard Care

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2011-08-03
• Last updated: 2014-07-24
• Results posted: 2014-05-05

Locations

7 sites across 1 country: United States