Dose Finding Study of HP802-247 in Venous Leg Ulcers

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.