DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Inclusion Criteria: * Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone) * target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration) * target wound that is not amendable to primary closure * target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial * adequate perfusion to the extremity * laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control) Exclusion Criteria: * untreated infection of soft tissue or bone * untreated autoimmune connective tissue disorders * body mass index (BMI) of ≥ 50 * undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication * active liver disease (e.g. hepatitis A-G), * have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment * pregnant * enrolled in any other interventional clinical research trial * an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.