Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

Inclusion Criteria

1. Male or female patients over 18 years of age who have given written informed consentin accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjectsmust be either of non-childbearing potential or if of child bearing potential mustsatisfy the defined contraceptive criteria Exclusion criteria h.
2. Patients who are willing and able to attend all follow up visits
3. Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has adiabetic 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 planimetryat the time of enrollment.
4. Index ulcer characteristics:
5. Ulcer present for ≥ 30 days prior to (Day 0)
6. Index ulcer is located below the ankle: at least 50% of the ulcer surface area isbelow the malleolus.
7. Subject has Body Mass Index (BMI) ≤ 45 at enrollment.
8. Subject has adequate circulation to the affected extremity, as demonstrated by atleast one of the following within the past 30 days:

• Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or
• ABIs with results of ≥ 0.7 and ≤ 1.2, Or
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of theaffected 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 aids

8. The subject is willing to accept treatment with a porcine based product 9. The subjectis medically stable, in the opinion of the investigator

Exclusion Criteria:

1. Index Ulcer Assessment:
2. Penetrates down to muscle, tendon, or bone
3. Presence of another diabetic foot ulcer within 2 cm of the index ulcer
4. Index ulcer determined to be due to Active Charcot deformity or previous surgicalcorrection for Charcot deformity.
5. Wounds which occur in relation to major structural abnormalities of the foot,which would include amputations related to osteomyelitis or Charcot deformity
6. Exhibits overt clinical signs and symptoms of infection with cellulitissurrounding the wound margin.
7. Known or suspected local skin malignancy to the index diabetic ulcer
8. Wound duration > one year without intermittent closure
9. Prior therapies - Subjects receiving treatment with any of the following will not beeligible for enrollment:
10. In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of theindex ulcer
11. In the last 7 days - Hyperbaric oxygen (HBO) therapy
12. In the last 10 days - Chemical debridement, hypochlorous acid or Dakin'ssolution, medical honey therapy
13. In the last 30 days - Treatment with cytotoxic chemotherapy, application oftopical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require suchmedications during the course of the study
14. In the last 30 days - study ulcer treatment with any advanced therapy, including,biomedical or topical growth factors, tissue engineered materials (e.g. Apligrafor Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or otherscaffold materials (e.g. OASIS® Wound Matrix, MatriStem Wound Matrix )
15. In the last 30 days - Subject has been on any investigational drug(s) ortherapeutic device(s)
16. In the last 8 weeks - Amputation or revascularization (surgical or stenting) tothe affected leg
17. Subject criteria that will make subject ineligible for enrollment:
18. Known hypersensitivity to porcine based products
19. Known osteomyelitis or active cellulitis requiring antimicrobial therapy at woundsite
20. End stage renal disease requiring dialysis.
21. Immune system disorders including Systemic Lupus Erythematosus (SLE), AcquiredImmunodeficiency Syndrome (AIDS) or HIV
22. Presence of any condition (including current drug or alcohol abuse, medical orpsychiatric condition) that is likely to impair understanding of or compliancewith the study protocol in the judgment of the Investigator
23. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, orwomen of childbearing potential who are planning to become pregnant during thetime of the study OR are unwilling/unable to use acceptable methods ofcontraception (birth control pills, barriers, or abstinence)
24. Subjects currently enrolled in this study. Concurrent enrollment in the study isprohibited
25. Subjects currently receiving radiation therapy or chemotherapy
26. Any pathology that would limit the blood supply and compromise healing ornon-revascularizable surgical sites