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A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

IRB Number

12-353

ClinicalTrials.gov Identifier

NCT01656889

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The purpose of this study is to determine the safety and effectiveness of the study drug, HP802-247 (a suspension of keratinocytes in a fibrin matrix), in healing venous leg ulcers as compared to the fibrin matrix alone.

Who is eligible to participate?

Males/Females 18 years of age and older with a venous leg ulcer.

What is involved?

Up to 22 weekly clinic visits (depending on when or if your wound heals), followed by up to six follow-up clinic visits every eight weeks until you have completed one full year of study participation.

How long is the study?

You will be in the study approximately 12 months.

Who can I contact for additional information?

You may contact Tiffany Whitaker, 217-545-2320 or email twhitaker@siumed.edu.

Who is the Principal Investigator of this study?

Doug Hood, MD

Where is the trial located?

Springfield, Illinois