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

Exclusion Criteria21

• Subject has a documented life expectancy of < 1 year.
• Index ulcer has been present for >1 year.
• Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
• Subject is unable to comply with offloading device.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
• Subject has ulcers that are completely necrotic or fibrotic tissue.
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
• The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
• Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.
• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• Index ulcer has reduced in area by 20% or more after 2 weeks of SOC from the first screening visit (S1) to the TV1/randomization visit.
• Subject is pregnant or breastfeeding.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
• Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening treatment visit 1.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
• Index ulcer and/or index limb with presence of, gangrene or unstable ischemia at screening (SV1).
• Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
• Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
• Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.