NCT02581488

Use of Santyl in Diabetic Foot Ulcers

Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.

Detailed description

The objectives of this study were to compare outcomes of diabetic foot ulcers (DFUs) treated with SANTYL or silver-containing products, both in combination with sharp debridement as needed. One hundred two subjects with qualifying DFUs were randomized to daily treatment with either SANTYL or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.

Conditions

• Diabetic Foot
• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
BIOLOGICAL	Santyl
OTHER	Product containing silver	Silver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2015-10-21
• Last updated: 2018-08-01
• Results posted: 2018-08-01

Locations

13 sites across 2 countries: United States, Canada