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

Venous Leg Ulcers Clinical Trial

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 ≤ 36 cm2

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01737762
Study type Interventional
Source Healthpoint
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 2012
Completion date May 2015
View Details
See also
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Unknown status NCT02224300 - Nursing Care With Patients With Venous Leg Ulcers Phase 2
Completed NCT01656889 - Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers Phase 3
Completed NCT02422017 - Topical Timolol Benefit in Venous Ulcers Phase 2