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

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.