drugset / Trial / NCT01656889

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

NCT01656889

Phase 3 Completed 447 enrolled Healthpoint Smith & Nephew, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

Timeline

Start
2012-08
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HP802-247 Cell therapy 0.26 ml Other

Indications