Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations
Condition: Varicose Ulcer; Venous Insufficiency
MeSH terms: Venous Insufficiency; Varicose Ulcer
Intervention: AmnioExCel dressing and compression therapy; SOC alginate dressing and compression therapy
Intervention description: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers; Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate and compare healing characteristics, reduction in
      the size of the wound and to measure complete healing of the wound following the application
      of a biologic product dressing instead of the alginate dressing along with standard
      debridement and compression therapy versus the standard of care treatment for VLUs. The
      biologic product that will be used in this study is called AmnioExCel™.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 years or older

          2. At least one VLU with a total surface area between 2 cm2 and 100 cm2

          3. VLU present for at least 1 month

          4. Presence of a VLU extending through the full thickness of the skin but not down to
             muscle, tendons, or bones

          5. Ulcer has a clean, granulating base with minimal adherent slough

          6. VLU has been treated with compression therapy for at least 14 days

          7. The study VLU has < 30% area reduction with SOC treatment for the duration ≥ 2 weeks
             screening period

          8. At least one of the following within the last 6 months:

               -  An Ankle-Brachial Index (ABI) of > 0.75

               -  Dorsalis Pedis (DP) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm
                  Hg for non-diabetic patients on study limb

               -  Posterior Tibial (PT) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60
                  mm Hg for non-diabetic patients on study limb

               -  Great toe systolic pressure ≥ 40 mm Hg

          9. Willingness to comply with the protocol, attend all follow-up visits, complete all
             protocol related assessments and provide informed consent

        Exclusion Criteria:

          1. Presence of an active infection of the skin on the target limb such as cellulitis
             requiring antibiotics

          2. Ulcer caused by a medical condition other than venous insufficiency

          3. Ulcer suspicious for cancer

          4. Known history of AIDS or HIV

          5. Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or
             EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months
             on the target VLU.

          6. Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days

          7. Known sensitivity to ethanol

          8. Uncontrolled diabetes mellitus with a HgBA1c of > 10% within the past 3 months

          9. Rheumatoid arthritis

         10. Significant lower extremity arterial occlusive disease that would preclude the use of
             compression therapy

         11. NYHA Class III and IV congestive heart failure (CHF)

         12. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the
             malleolus

         13. Currently receiving radiation therapy or chemotherapy

         14. Receiving immune modulators

         15. Currently pregnant or trying to get pregnant

         16. Breast feeding

         17. Not willing to provide written informed consent or remain in compliance with the study
             protocol requirements