Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Inclusion Criteria:

• The potential subject must be at least 18 years of age or older.

• The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.

• At enrollment, the potential subject must have a target ulcer with a minimum surfacearea of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridementwith the imaging device length times width.

• The potential subject must have a target ulcer that has been present for a minimumof 4 weeks of standard of care, prior to the initial screening visit.

• The potential subject must have a target ulcer located on the foot with at least 50%of the ulcer below the malleolus.

• The potential subject must have a target ulcer that is Wagner 1 or 2 grade,extending at least through the dermis or subcutaneous tissue and may involve themuscle provided it is below the medial aspect of the malleolus. The ulcer may notinclude exposed tendon or bone.

• The potential subject's affected limb must have adequate perfusion confirmed byvascular assessment. Any of the following methods performed within 3 months of thefirst screening visit are acceptable:

1. ABI between 0.7 and ≤ 1.3;

2. TBI ≥ 0.6;

3. TCOM ≥ 40 mmHg;

4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must beseparated by at least 2 cm. The largest ulcer satisfying the inclusion andexclusion criteria will be designated as the target ulcer.

• The potential subject must have a target ulcer located on the 50% below themalleolus and not on the dorsal toes.

• The ulcer must be offloaded for at least 14 days prior to enrollment.

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

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

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

Exclusion Criteria:

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

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

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

• The target ulcer exposes tendon or bone.

• There is evidence of osteomyelitis complicating the target ulcer.

• The potential subject is receiving immunosuppressants (including systemiccorticosteroids at doses greater than 10 mg of prednisone per day or equivalent) orcytotoxic chemotherapy or is taking medications that the PI believes will interferewith wound healing (e.g., biologics).

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

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

• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12%within 3 months of the initial screening visit.

• The surface area of the potential subject's target ulcer has reduced in size by morethan 20% in the 2 weeks prior to the initial screening visit ("historical" run-inperiod). Imaging Device is not required for measurements taken during the historicalrun-in period (e.g., calculating surface area using length X width is acceptable).

• The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initialscreening visit (S1) to the TV-1 visit during which time the potential subjectreceived SOC.

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

• The potential subject is a woman who is pregnant or considering becoming pregnantwithin the next 6 months.

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

• The potential subject has participated in a clinical trial involving treatment withan investigational product within the previous 30 days.

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

• 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.

• The potential subject has a malnutrition.

• The potential subject has a known allergy or sensitivity to PBS, IPA, processingsolutions, reagents, or latex.