AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

Inclusion Criteria:

1. Have participated in the informed consent process and signed a study-specific informed
consent document.

2. Be able and willing to comply with study procedures, including study visits, study
dressing regimens, and compliance with study required offloading device.

3. Be ≥ 21 years of age.

4. Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated
hemoglobin (HbA1c) of ≤ 12%.

5. Have at least one diabetic foot ulcer Ulcer size (i.e., area) is > 1 cm2 and < 12 cm2.

6. Have adequate vascular perfusion of the affected limb

Exclusion Criteria:

1. The subject was previously randomized and treated under this clinical study protocol.

2. The study ulcer has features that necessitates surgical operating-room debridement
and/or penetrates to capsule/tendon/bone.

3. The subject is unable to safely ambulate with the use of a study required offloading
boot.

4. The subject has suspected or confirmed gangrene or wound infection of the study ulcer.

5. The subject has suspected or confirmed osteomyelitis.

6. In the opinion of the Investigator, the subject has received or is scheduled to
receive during study participation, a medication or treatment which is known to
interfere with or affect the rate and quality of wound healing

7. The subject has a history of bone cancer or metastatic disease of the affected limb,
radiation therapy to the foot, or has had chemotherapy prior to signing the Informed
Consent Form for trial participation.

8. The subject is currently pregnant or is actively trying to conceive.

9. In the opinion of the Investigator, the subject is unable to comply with the treatment
regimen

10. In the opinion of the Investigator, the subject has a history of, or is currently
diagnosed with, any illness or condition, other than diabetes, that could interfere
with wound healing.

11. In the opinion of the Investigator, the subject has a condition that could inhibit
wound healing.

12. The subject has ulcers secondary to a disease other than diabetes.