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Trial Underway Testing Placenta Grafts for Foot Ulcers

Pregnant woman

(Freestocks.org, Unsplash)

1 Feb. 2019. A clinical trial testing tissue grafts derived from human placenta tissue to treat diabetic foot ulcers enrolled its first patient. StimLabs LLC in Roswell, Georgia, the company developing the grafts and sponsoring the study, announced the enrollment today.

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.

The study is testing StimLabs’ graft to treat diabetic foot ulcers brand-named Revita, made from a donated intact human placental membrane, according to the company. The grafts include the amnion and chorion layers from the placenta that protect and support development of the fetus. StimLabs says the graft also provides many growth factor proteins, cytokines, and cellular signaling that encourage wound healing.

StimLabs says its Clearify process converts donated placenta tissue into grafts for foot ulcer wounds and other applications. That process removes remnants of blood from the placental membrane, while retaining the rest of the natural tissue layers, which the company says are not disturbed. Among the retained components is a spongy intermediate layer between the amnion and chorion, which contains hyaluronic acid, collagen, and growth factors, as well as acting as a cushion. StimLabs says processed tissue is then freeze-dried, which preserves it for up to 5 years.

The clinical trial is recruiting 40 individuals at sites in Florida, Louisiana, and Pennsylvania. Participants will have either type 1 or type 2 diabetes and foot ulcers for at least 4 weeks. Those enrolled will be randomly assigned to receive a Revita graft or the usual standard care for foot ulcers. The study team is looking primarily at the number of participants achieving 100 percent epithelization or wound closure after 12 weeks, but is also measuring the percentage of the wound healing during that time.

StimLabs is not the only company developing diabetic wound healing products from birth mother tissue donations. As reported by Science & Enterprise in September 2018, results from a clinical trial testing skin grafts made by MiMedex Group from donated umbilical cord tissue show the grafts heal more diabetic foot ulcers than alginate dressings, a common treatment for the condition.

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