Dose Finding Study of HP802-247 in Venous Leg Ulcers



Status:Completed
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2009
End Date:July 2011

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A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
30
sites
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Arlington, Texas 76011
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Baltimore, Maryland 21231
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Bellevue, Washington 98004
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Boston, Massachusetts 02118
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Boston, MA
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Castro Valley, California 94546
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Castro Valley, CA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Dallas, Texas 75093
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Emerson, New Jersey 07630
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Encinitas, California 92024
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Harrisburg, Pennsylvania 17112
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Jacksonville, Illinois 62650
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Las Vegas, Nevada 89119
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London,
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Los Angeles, California 90048
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Lubbock, TX
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New York, New Jersey 10025
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North Chicago, Illinois 60064
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Reading, Pennsylvania 19601
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San Antonio, Texas 78205
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San Diego, California 92013
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South Miami, Florida 33143
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Spokane, WA
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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St. George, UT
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Stoughton, Massachusetts 02972
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Summit, New Jersey 07901
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Tamarac, Florida 33321
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Tucson, Arizona 85724
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