Ulcer Clinical Trial
Official title:
A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)
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.
At least 440 subjects will participate. The study is going to be conducted in approximately
5 countries at approximately 50 sites across the European Union.
See Brief Summary ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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