Dose Finding Study of HP802-247 in Venous Leg Ulcers

Completed · Phase 2 · Has a placebo group

Conditions studied: Venous Leg Ulcer, Venous Stasis Ulcers

In brief

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Key facts

Study ID

NCT00852995

Run by

Healthpoint

People needed

228

Starts

2009-02-01

Expected to finish

2011-07-01

Last updated by the study team

2016-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide informed consent.
• Willing to comply with protocol instructions, including allowing all study assessments.
• Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
• Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
• Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

You may not qualify if…

• Women who are pregnant or lactating
• Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
• A target ulcer of non-venous etiologies.
• Refusal of or inability to tolerate compression therapy.
• Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
• Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.

Where it is running

• University of AZ College of Medicine — Tucson, Arizona, United States
• Center for Clinical Research — Castro Valley, California, United States
• ILD Consulting, Inc. — Encinitas, California, United States
• Vascular Surgery Associates — Los Angeles, California, United States
• UCSD Wound Treatment and Research Center — San Diego, California, United States
• University of Miami — Miami, Florida, United States
• Doctors Research Network — South Miami, Florida, United States
• Robert J. Snyder — Tamarac, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Passavant Area Hospital — Jacksonville, Illinois, United States
• Rosalind Franklin University — North Chicago, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Johns Hopkins Wound Center — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• New England Sinai Hospital — Stoughton, Massachusetts, United States
• Advanced Foot and Ankle Center — Las Vegas, Nevada, United States
• Vincent Giacalone — Emerson, New Jersey, United States
• St. Luke's Roosevelt Hospital Center — New York, New Jersey, United States
• Overlook Hospital Wound Healing Program — Summit, New Jersey, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Harrisburg Foot and Ankle Center — Harrisburg, Pennsylvania, United States
• Center for Advanced Wound Care — Reading, Pennsylvania, United States
• Arlington Research Center — Arlington, Texas, United States
• Wound Care Consultants — Dallas, Texas, United States
• Southwest Regional Wound Care Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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