At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver
In Brief
A Phase 4 clinical trial evaluating Santyl and Product containing silver for Diabetic Foot and Foot Ulcer, Diabetic. Completed, enrolled 102 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Silver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer