A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

Inclusion Criteria:

• Provide informed consent
• Age ≥ 18 years and of either sex
• Willing to comply with protocol instructions, including allowing all study assessments
• Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
• Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence
• Arterial supply adequacy confirmed
• Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
• Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months).
• Acceptable state of health and nutrition

Exclusion Criteria:

• History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine
• Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication
• Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial
• A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic)
• Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit
• Refusal of or inability to tolerate compression therapy
• Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
• Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
• Current therapy with systemic antibiotics
• Current systemic therapy with cytotoxic drugs
• Current therapy with chronic (> 10 days) oral corticosteroids
• Current therapy with TNFα inhibitors
• History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)