Many people with diabetes will develop foot wounds. If this type of wound does not heal, it can develop into a diabetic foot wound (DFU).

If your podiatrist has tried to heal your ulcer with standard care, but it does not respond after 30 days, the DFU may have stalled during the healing process. New research suggests the reason why DFUs may “stall” in the healing process is due to a decrease in the activity level of genes responsible for replication and activation of immune cells. A stalled DFU may prompt your podiatrist to suggest using an amniotic membrane wound covering.

What Are Amniotic Membrane Wound Coverings?

Amniotic membrane wound coverings are protective coverings derived from donated human placental-based tissue. This human amniotic tissue is donated from pregnant mothers undergoing a planned caesarean (“C”) section. The tissue is extracted, processed, and preserved as a same-species tissue graft (allograft) which is applied to the wound. The allograft creates an environment for healing, and can help advance the DFU from stalled to closed.

Are All Amniotic Membrane Wound Coverings the Same?

There are different amniotic membrane wound coverings available. They all begin with the same raw material, however, how the cells are preserved is a distinction between them.

Many protective wound covering products are preserved by either dehydration or cryopreservation (freezing). Affinity® wound coverings, however, are not dehydrated or frozen. They are the only fresh amniotic membrane wound coverings available.

The maker of Affinity® has developed a special hypothermic method of preservation called Allofresh™ which keeps the amniotic tissue in its fresh state. Because it is fresh, Affinity® has a much shorter shelf life than dehydrated or frozen amniotic tissue. Many believe the fresh state of Affinity® helps it retain superior tissue composition and cell viability. The Allofresh™ method keeps amniotic tissue fresh by:

  • Separating the amniotic membranes of donated human placental tissue, and retaining only the innermost membrane layer (the amnion)
  • Cleaning the amnion, treating it with an antibiotic solution, and rinsing it
  • Sizing and packaging the amnion
  • Refrigerating it at above-freezing temperatures

What Is Special About the Allofresh™ process?

The unique Allofresh™ process is believed to retain cell viability and structure, growth factors, and other key components of the immune system. Allofresh™ preserves the characteristics of—and is the closest thing to—native amniotic tissue.

In randomized controlled trials, Affinity® has supported faster closure in the area, depth and volume of many DFUs—as compared to standard wound care.

Is Affinity® Safe?

There are stringent protocols for processing and procuring Affinity®. Donors are pre-screened, and undergo a thorough prenatal examination and medical review. Affinity® allografts are also put through stringent testing by FDA-registered labs and the United States Pharmacopeia (USP) organization.

If you have a diabetic wound that is not healing after 30 days of standard care, talk to your podiatrist about Affinity® fresh amniotic membrane grafts.

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