A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

Inclusion Criteria:

1. At least 18 years of age or older.

2. Diagnosis of type 1 or 2 Diabetes mellitus.

3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2

4. The target ulcer must have been present for a minimum of 4 weeks

5. The target ulcer must be located on the foot with at least 50% of the ulcer belowthe malleolus.

6. The target ulcer must be Wagner 1 or 2 grade

7. The affected limb must have adequate perfusion confirmed by vascular assessment.

8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will bedesignated as the target ulcer.

9. Target ulcers located on the plantar aspect of the foot must be offloaded for atleast 14 days prior to enrollment.

10. The potential subject must consent to using the prescribed offloading method for theduration of the study.

11. The potential subject must agree to attend the weekly study visits required by theprotocol.

12. The potential subject must be willing and able to participate in the informedconsent process.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of < 6 months.

2. The potential subject's target ulcer is not secondary to diabetes.

3. The target ulcer is infected or there is cellulitis in the surrounding skin.

4. The target ulcer exposes tendon or bone.

5. There is evidence of osteomyelitis

6. There is an infection in the target ulcer or in a remote location that requiressystemic antibiotic therapy.

7. The potential subject is receiving immunosuppressants or cytotoxic chemotherapy oris taking medications that the PI believes will interfere with wound healing.

8. The potential subject is taking hydroxyurea.

9. The potential subject has applied topical steroids to the ulcer surface within onemonth of initial screening.

10. The potential subject with a previous partial amputation on the affected foot thatresults in a deformity that impedes proper offloading of the target ulcer.

11. The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 monthsof the initial screening visit.

12. The potential subject has an acute Charcot foot, or an inactive Charcot foot, whichimpedes proper offloading of the target ulcer.

13. Women who are pregnant or considering becoming pregnant within the next 6 months.

14. The potential subject has end stage renal disease requiring dialysis.

15. Participation in a clinical trial involving treatment with an investigationalproduct within the previous 30 days.

16. A potential subject who, in the opinion of the investigator, has a medical orpsychological condition that may interfere with study assessments.

17. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or aCellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initialscreening visit.

18. The potential subject has a malnutrition indicator score <17 as measured on the MiniNutritional Assessment.