Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM

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 preceding screening.
• •Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
• •Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
• •Has malignancy or history of cancer in 5 years preceding the screening visit other than non-melanoma skin cancer.
• •Pregnant women.
• •Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
• •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.
• •Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced 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., with evidence 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 symptoms of target ulcer infection.
• •Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.
• •The target ulcer has decreased \> 30% in wound area post debridement at baseline following the two-week run-in period.
• •Use of excluded concomitant medications, therapies, or procedures during the two-week run-in period.
• •Has clinical signs or symptoms of infection within the target ulcer.