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

Inclusion 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 thescreening visit.

3. Has a VLU between the knee and ankle (at or above the malleoli), with a surface areain the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff atthe screening visit using the eKare device post debridement.

4. If the subject presents with > 1, but ≤ 3 VLU on the same leg, the largestulcer will be selected as the target ulcer.

5. If the target ulcer is < 1cm from another VLU, the ulcers should be traced as asingle target ulcer provided at least one of the ulcers is at least 2.0 cm2 inarea and the total surface area of the VLUs is ≤ 20.0 cm2.

6. Target ulcer involves a full-thickness skin loss, but without exposure of tendon,muscle, or bone.

7. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).

8. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular orvenous incompetence. a. Availability of a complete report of a previous examination performed 12 monthsof screening will be acceptable, and this examination would not be required to berepeated.

9. Arterial supply adequacy confirmed by any one of the following:

10. Great toe pressure ≥ 50 mm/Hg

11. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10

12. TcPO2 ≥ 40 mmHg from the foot

13. Willing to follow all instructions given by the Investigator, return for all visits,and adhere to compression protocols while on the study.

Exclusion Criteria:

1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosislipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).

2. Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset ofsymptoms, or any DVT for which compression is considered by the Investigator to becontraindicated.

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 aneffective 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 ImmuneDeficiency Syndrome (AIDS).

14. Has malignancy or history of cancer in the preceding 5 years other than non-melanomaskin cancer.

15. Currently on dialysis or planning to start dialysis.

16. Is currently enrolled or participated in another device, drug, or biological trialwithin 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) dayspreceding the screening visit.

19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.