Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Eligibility Criteria

• 1. Patient has signed the informed consent form.
• 2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.
• 3. Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
• 1. If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
• 2. If the target ulcer is \< 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.
• 4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
• 5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
• 6. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
• 7. Arterial supply adequacy confirmed by any one of the following:
• 1. Great toe pressure ≥ 50 mm/Hg
• 2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
• 3. TcPO2 ≥ 40 mmHg from the foot
• 8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.
• 1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
• 2. Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
• 3. Clinical evidence of ulcer bed infection, or infected hardware.
• 4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
• 5. Refusal or inability to tolerate compression therapy.
• 6. Pregnant women.
• 7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
• 8. Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
• 9. Current therapy with systemic antibiotics.
• 10. Current therapy with cytotoxic agents.
• 11. Current therapy with chronic (\> 10 days) oral corticosteroids.
• 12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
• 13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
• 14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
• 15. Currently on dialysis or planning to start dialysis.
• 16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
• 17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
• 18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
• 19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.