Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Exclusion Criteria

• •1. Hemoglobin A1c (HbA1c) level is \> 10%.
• •2. Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
• •3. Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
• •4. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
• •5. Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
• •6. Pregnant or lactating women.
• •7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
• •8. Currently on dialysis or planning to start dialysis.
• •9. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
• •10. Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
• •11. Current use of topical anti-microbial or silver-containing products.
• •12. Target ulcer is over an active or inactive Charcot deformity.
• •13. The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
• •14. Gangrene is present on any part of the affected foot.
• •15. Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
• •16. Any previous use of human placental membrane applied to the target ulcer.