Health Technology Brief

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Grafix Cryopreserved Placental Membrane (Osiris Technologies Inc.) for Treatment of Chronic Foot Ulcers in Patients with Diabetes Mellitus

September 3, 2019

Health Problem: Diabetes can damage blood vessels, compromising blood flow and oxygen circulation. Resulting tissue hypoxia may contribute to failure of even minor wounds to heal. Chronic foot ulcers in people with diabetes may occur when foot injuries, such as cuts, blisters, or sores, develop, worsen, and do not heal. Reasons are multifactorial and may include compromised sensation due to diabetes-related nerve damage and poor blood flow due to diabetes-related blood vessel damage.

Technology Description: Grafix Cryopreserved Placental Membrane is intact and preserved human placental tissue that contains collagen-rich matrix, growth factors, epithelial cells, fibroblasts, and mesenchymal stem cells. It is used as an adjunctive treatment to standard wound care. Grafix is stored at -80?C for up to 2 years. After thawing and rinsing, a Grafix membrane is applied to a clean wound bed and covered with a nonadherent dressing. Grafix is applied weekly after standard wound care until complete wound closure.

Controversy: There are numerous skin substitutes for chronic wound healing available on the market. Grafix Cryopreserved Placental Membrane is an intact and viable human tissue. The extracellular matrix, growth factors, and living cells naturally present in Grafix are believed to promote wound healing. However, it is undetermined whether Grafix application to chronic diabetes-related foot ulcers is more effective than standard wound care alone.

Key Questions:

  • Is Grafix Cryopreserved Placental Membrane effective in treating chronic foot ulcers in adults with diabetes mellitus (DM)?
  • How does Grafix Cryopreserved Placental Membrane compare with other treatments for chronic foot ulcers in adults with DM?
  • Is Grafix Cryopreserved Placental Membrane safe?
  • Have definitive patient selection criteria been identified for Grafix Cryopreserved Placental Membrane?