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 |
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.
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
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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University of Miami A private research university with more than 15,000 students from around the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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