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.

Exclusion criteria