STERILIZED, PORCINE PLACENTAL TISSUE IN THE TREATMENT OF CHRONIC DIABETIC FOOT ULCERS

A Prospective, Non-Randomized, Multi-Center Observational StudyTo determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Inclusion CriteriaMale or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of child bearing potential must satisfy the defined contraceptive criteria Exclusion criteria h.Patients who are willing and able to attend all follow up visitsSubject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment.Index ulcer characteristics:Ulcer present for ≥ 30 days prior to (Day 0)Index ulcer is located below the ankle: at least 50% of the ulcer surface area is below the malleolus.Subject has Body Mass Index (BMI) ≤ 45 at enrollment.Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OrABIs with results of ≥ 0.7 and ≤ 1.2, OrDoppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI >1.2 TBI (Toe Brachial Index) > 0.5.Patient able to ambulate at home or in the clinic with or without mobility aids8. The subject is willing to accept treatment with a porcine based product 9. The subject is medically stable, in the opinion of the investigatorExclusion Criteria:Index Ulcer Assessment:Penetrates down to muscle, tendon, or bonePresence of another diabetic foot ulcer within 2 cm of the index ulcerIndex ulcer determined to be due to Active Charcot deformity or previous surgical correction for Charcot deformity.Wounds which occur in relation to major structural abnormalities of the foot, which would include amputations related to osteomyelitis or Charcot deformityExhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.Known or suspected local skin malignancy to the index diabetic ulcerWound duration > one year without intermittent closurePrior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcerIn the last 7 days - Hyperbaric oxygen (HBO) therapyIn the last 10 days - Chemical debridement, hypochlorous acid or Dakin's solution, medical honey therapyIn the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the studyIn the last 30 days - study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem Wound Matrix )In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected legSubject criteria that will make subject ineligible for enrollment:Known hypersensitivity to porcine based productsKnown osteomyelitis or active cellulitis requiring antimicrobial therapy at wound siteEnd stage renal disease requiring dialysis.Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIVPresence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the InvestigatorPregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibitedSubjects currently receiving radiation therapy or chemotherapyAny pathology that would limit the blood supply and compromise healing or non-revascularizable surgical sites