Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Exclusion Criteria

• •1. Be pregnant or lactating
• •2. Subjects with a target wound \<30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline/Visit 2)
• •3. Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)
• •4. Have a serum creatinine concentration of 3.0 mg/dL or greater within 30 days prior to screening (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)
• •5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
• •6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
• •7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit
• •8. Need for any additional concomitant dressing material other than the ones approved for this study
• •9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
• •10. Have the inability to tolerate an off-loading boot
• •11. Have a known or suspected disease of the immune system
• •12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease
• •13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit
• •14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline/Visit 2)
• •15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit
• •16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening/Visit 1 if subject had labs collected \<30 days of screening; assessed at Baseline/Visit 2 if subject had labs collected at screening)
• •17. Have active Charcot disease
• •18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
• •19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
• •20. Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated