Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
Condition: Venous Leg Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: HP802-247; Vehicle
Intervention description: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous leg ulcer; ulcer; Venous stasis; compression; venous; venous stasis ulcer; vlu; wound; varicose veins; venous insufficiency; dvt; deep vein thrombosis

Summary:

      This study is being done to find out if an investigational product called HP802-247 can help
      people with venous leg ulcers. Investigational means that HP802-247 has not been approved by
      the U.S. Food and Drug Administration (FDA).

      At least 250 subjects will participate. The study is going to be conducted in approximately
      50 sites in the United States and Canada.
    

Eligibility criteria:

        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 >12 cm2 to ≤ 36 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.