A Prospective Trial of Non-healing Diabetic Foot 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 thescreening visit.

• Confirmed diagnosis of Type 1 or Type 2 Diabetes.

• Has a DFU that is located below the malleoli at least 1.0 cm2 or up to 20.0 cm2 whenmeasured by the investigator staff at the screening visit using the Tissue Analyticsdevice post debridement. a. If more than one ulcer is present the selected target ulcer must be at least 2 cmfrom the nearest edge of any adjacent ulcers.

• The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with noevidence of exposed muscle, tendon, bone, or joint capsule.

• The target ulcer is "chronic, hard-to-heal," defined as having a duration of > 4weeks but ≤ 52 weeks at the time of the screening visit.

• Arterial supply adequacy to the foot with the target ulcer confirmed by any one ofthe following:

1. Great toe pressure ≥ 40 mm/Hg

2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20

3. TcPO2 ≥ 30 mmHg from the foot

4. Toe Brachial Index or TBI ≥ 0.50

• Willing to follow all instructions given by the Investigator, return for all visits,and adhere to off-loading protocols while on the study.

Exclusion Criteria:

• Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol).

• Chronic oral steroid use of > 7.5 mg daily within the previous 30 days precedingscreening.

• Chronic oral or parenteral corticosteroids, or any cytotoxic agents within theprevious 30 days preceding screening.

• Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired ImmuneDeficiency Syndrome (AIDS).

• Has malignancy or history of cancer in 5 years preceding the screening visit otherthan non-melanoma skin cancer.

• Pregnant women.

• Women of child-bearing potential who are unwilling to avoid pregnancy or use aneffective form of birth control.

• Currently on dialysis or planning to start dialysis.

• Is currently enrolled or participated in another device, drug, or biological trialwithin 30 days of screening.

• Has used wound treatments with enzymes, growth factors, living skin, dermalsubstitutes including other amniotic or umbilical cord tissue therapies, or otheradvanced biological therapies within the last 30 days.

• Current use of topical anti-microbial or silver-containing products.

• Target ulcer is over an active or inactive Charcot deformity.

• The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., withevidence of exposed muscle, tendon, bone, and/or joint capsule.

• Gangrene is present on any part of the affected foot.

• Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptomsof target ulcer infection.

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

The following additional exclusion criteria should be reviewed for all subjects at the end of the screening run-in period prior to randomization for eligibility determination:

• The target ulcer has decreased > 30% in wound area post debridement at baselinefollowing the two-week run-in period.

• Use of excluded concomitant medications, therapies, or procedures during thetwo-week run-in period.

• Has clinical signs or symptoms of infection within the target ulcer.