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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.
Ages:18 and older
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.
Phase: Phase 2
Trial ID: NCT00852995
Not Accepting Healthy Volunteers