Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of 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 ≥ 2.0 cm2 and ≤ 12.0 cm2

- 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 ≥ 6 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.

- 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.