Status:
COMPLETED
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Lead Sponsor:
Healthpoint
Conditions:
Venous Leg Ulcer
Venous Stasis Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 concentr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00852995
Start Date
February 1 2009
End Date
July 1 2011
Last Update
October 24 2016
Active Locations (30)
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1
University of AZ College of Medicine
Tucson, Arizona, United States, 85724
2
Center for Clinical Research
Castro Valley, California, United States, 94546
3
ILD Consulting, Inc.
Encinitas, California, United States, 92024
4
Vascular Surgery Associates
Los Angeles, California, United States, 90048