drugset / Trial / NCT02111291

Santyl Applications to Diabetic Foot Ulcers

NCT02111291

Phase 4 Completed 215 enrolled Healthpoint
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-04
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic

Indications