NCT02111291

Santyl Applications to Diabetic Foot Ulcers

Clinical Outcomes Associated With Enzymatic Debridement of Diabetic Foot Ulcers for Up To 12 Weeks With Clostridial Collagenase (Santyl®) Ointment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.

Conditions

• Diabetic Foot Ulcers
• Diabetic Foot Wounds

Interventions

Type	Name	Description
BIOLOGICAL	Collagenase SANTYL® Ointment	Daily application directly to the ulcer bed, approximately 2 mm thick.
BIOLOGICAL	Hydrogel (if needed) and foam dressing	Daily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-04-11
• Last updated: 2016-02-17

Locations

25 sites across 2 countries: United States, Canada