Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

Exclusion Criteria

• •History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
• •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.
• •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 autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
• •History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
• •Any prior exposure to HP802-247 or its vehicle.