A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

Summary

The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.

Timeline

Start

2000-12

Primary completion

—

Completion

2004-02

Outcome

Outcome not reported

Stopped (Enrollment): “Slow recruitment; Study did not address safety concern raised by European Medicines Agency”

Drugs

Indications