Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
Condition: Venous Ulcer; Venous Stasis Ulcer; Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: HP802-247; HP802-247 Vehicle
Intervention description: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.; HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 252.0
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).

      This research is being done to compare the efficacy of HP802-247 plus compression therapy
      against Vehicle plus compression therapy in achieving complete wound closure over the 12-week
      treatment period. Vehicle looks the same as HP802-247 but contains no cells.

      At least 440 subjects will participate. The study is going to be conducted in approximately 5
      countries at approximately 50 sites across the European Union.
    

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 ≥ 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.