Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

Inclusion Criteria:

1. Subjects18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.

2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oralmedications and/or insulin replacement therapy.

3. Subjects with the following ulcer: A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screeningvisit on any aspect of the foot, provided it is at or below the aspect of the medialmalleolus. [NOTE: If two or more DFUs are present with the same grade, the indexulcer is the largest ulcer and the only one evaluated in the study. Index ulcer mustbe more than 5 cm distant apart]. B. A diabetic foot ulcer present for greater than 4 weeks (documented in the medicalrecord) but less than 12 months duration if being treated with active SOC.

4. Objectively, less than 20% healing in the two-week screening period prior torandomization.

5. Study ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 post-debridement atfirst treatment visit.

6. Index ulcer and/or index ulcer limb may have had prior infection, but infection(s)must be adequately treated and controlled as defined by IDSA Guidelines Grade level

8. The subject is able and willing to follow the protocol requirements.

9. Subject has signed informed consent.

10. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneousoxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the firstScreening Visit.

11. Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one year or surgically sterile). Females of childbearingpotential must be willing to use acceptable methods of contraception (birth controlpills, barriers, or abstinence) starting at Screening and continuing through theduration of their study participation.

12. The index ulcer has been offloaded with protocol defined offloading devicethroughout the study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through TV1/Randomization).

13. The index ulcer has a clean base and is free of necrotic debris at time of placementof treatment product.

Exclusion Criteria:

1. Subject has a known life expectancy of < 1 year.

2. Index ulcer has been present for >1 year.

3. Patient does not have adequate 2-week historical data demonstrating < 20% areareduction.

4. Subject is unable to comply with offloading device.

5. Presence of any condition(s) which seriously compromises the subject's ability tocomplete this study or has a known history of poor adherence to medical treatment.

6. Subject has ulcers that are completely necrotic or fibrotic tissue

7. Subject has major uncontrolled medical disorders such as serious cardiovascular,renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.

8. Subject currently being treated for an active malignant disease or subjects withhistory of malignancy within the ulcer.

9. The Subject has other concurrent conditions that in the opinion of the PrincipalInvestigator may compromise subject safety.

10. Known contraindications to acellular dermal matrices or known allergies to any ofthe Derm-Maxx components.

11. Concurrent participation in another clinical trial that involves an investigationaldrug or device that would interfere with this study.

12. Index ulcer has reduced in area by 20% or more after 2 weeks of standard of carefrom the first screening visit (S1) to the TV1/randomization visit.

13. Subject is pregnant or breastfeeding.

14. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, orapplication of topical steroids to the ulcer surface within 30 days prior torandomization visit or who receive such medications during the screening period, orwho are anticipated to require such medications during the course of the study.

15. Index ulcer has been previously treated with tissue engineered materials (e.g.Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) withinthe last 30 days preceding the first treatment visit.

16. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks ofscreening visit 1.

17. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0within 30 days of randomization (TV1).

18. Index ulcer and/or index limb with presence of gangrene or unstable ischemia atscreening (SV1).

19. Revascularization surgery on the lower extremity on which the index ulcer is locatedwithin 30 days of Screening Visit (SV1).

20. Index ulcer in the opinion of the Principal Investigator, is suspicious for cancerand should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.

21. Any clinically significant finding, in the judgment of the Principal Investigator,that would place the subject at health risk, impact the study, or affect thecompletion of the study.