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

Inclusion criteria

• Patient has signed the informed consent form.
• Male or female patient at least 18 years of age or older, as of the date of the screening visit.
• 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.
• If the subject presents with \> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
• 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.
• Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
• Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
• Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence. a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.
• Arterial supply adequacy confirmed by any one of the following:
• Great toe pressure ≥ 50 mm/Hg
• Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
• TcPO2 ≥ 40 mmHg from the foot
• Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.

Exclusion criteria

• A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
• 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.
• Clinical evidence of ulcer bed infection, or infected hardware.
• Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
• Refusal or inability to tolerate compression therapy.
• Pregnant women.
• Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
• Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
• Current therapy with systemic antibiotics.
• Current therapy with cytotoxic agents.
• Current therapy with chronic (\> 10 days) oral corticosteroids.
• Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
• Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
• Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
• Currently on dialysis or planning to start dialysis.
• Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
• Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
• Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
• Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.