NCT01143714

A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	Santyl	Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
OTHER	White Petrolatum	Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-04-01
• Completion: 2012-10-01
• First posted: 2010-06-14
• Last updated: 2013-05-06
• Results posted: 2013-05-03

Locations

6 sites across 1 country: United States