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Umbilical Cord Grafts Shown to Heal Foot Ulcers

Pregnant woman

(Sergio Santos, nursingschoolsnearme.com, Flickr)

25 September 2018. Results from a clinical trial show skin grafts made from dehydrated human umbilical cord tissue heal more diabetic foot ulcers than alginate dressings, a common treatment for the condition. Findings from the trial sponsored by MiMedx Group Inc. — developer of EpiCord, the treatment tested in the study — appear in yesterday’s issue of International Wound Journal.

People with diabetes often develop slow-healing skin ulcers on their feet, a common complication of the disease. In people with diabetes, blood flow is reduced to the legs and feet, leading to nerve damage and reduced feeling in those regions, as well as slower healing of wounds. Centers for Disease Control and Prevention says in 2010, some 73,000 Americans required amputation of a leg or foot because of complications from diabetes. While malnutrition and immune deficiencies can also cause chronic wounds, CDC says people with diabetes are 8 times more likely to lose a leg or foot than people without diabetes.

EpiCord uses tissue from human umbilical cords for wound healing. The umbilical cord provides blood and nutrients from the mother to the fetus and is usually discarded after birth. But the cord is made from layers of amniotic membrane and a substance called Wharton’s Jelly that is also a source of stem cells and growth factors, thus increasingly studied as a source of regenerative medical solutions.

MiMedx removes blood components from the umbilical cord, preserving the scaffold and extracellular matrix in the amniotic membrane. The dehydrated and sterilized amniotic membrane tissue, says MiMedx, both protects the wound while healing and provides a connective tissue matrix to supplement damaged or inadequate tissue in the wound.

The clinical trial tested EpiCord skin grafts against alginate dressings as treatments for diabetic foot ulcers. The study enrolled 134 participants with chronic diabetic foot ulcers who completed the treatments at 11 sites in the U.S. The participants were randomly assigned on a 2-to-1 ration to receive new EpiCord or alginate dressing treatments each week, in addition to weekly wound cleaning and damaged tissue removal.

After 12 weeks, 70 percent of the EpiCord recipients reported complete healing of their foot ulcers, compared to 48 percent of those receiving alginate treatments. Of the participants receiving adequate wound cleaning and damaged tissue removal, 96 percent of EpiCord recipients reported completed wound healing, compared to 65 percent in the alginate group.

Some 75 participants experienced a total of 160 adverse effects during the trial. However, the study team says none of the adverse effects were related to the treatment and 1 each in the EpiCord and alginate groups reported adverse effects resulting from the study process other than the treatments.

The authors conclude the results show skin grafts from umbilical cord tissue are safe and effective treatments for diabetic foot ulcers. But the results also highlight the importance of adequate continuous care of the wounds that increase the efficacy both treatments.

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