Clinical Trial: Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤

Brief 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 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.


Detailed Summary:
Sponsor: Healthpoint

Current Primary Outcome: Wound Closure [ Time Frame: 16 Weeks ]

Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome: Time in Days to Closure [ Time Frame: 16 Weeks ]

Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.


Original Secondary Outcome: Same as current

Information By: Healthpoint

Dates:
Date Received: November 20, 2012
Date Started: November 2012
Date Completion: May 2015
Last Updated: November 13, 2014
Last Verified: November 2014