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Umbilical Cord-Based Technology May Offer Hope for Diabetic Foot Ulcers

July 31, 2014

Wound care therapy developer Amniox Medical announced Tuesday the start of a clinical trial of Neox Cord 1K, an exclusive cryopreserved umbilical cord allograft for the treatment of chronic diabetic foot ulcers.

Neox Cord 1K is composed of amniotic membrane and umbilical cord, the Marietta, Ga., company said, adding that these tissues contain key proteins, cytokines and growth factors that have been shown to curb inflammation and spur regeneration of normal tissue. The natural biological and structural integrity of these tissues is preserved using the company’s patented CryoTek cryopreservation technology.

Amniox expects to enroll 30 patients with nonhealing diabetic foot ulcers in the multicenter, randomized CONDUCT 1 study, which will pit Neox Cord 1K against the standard of care. The aim is to demonstrate that the technology is clinically effective and cost-efficient, the company said.

David Armstrong, who co-developed the study protocol, said placental tissue technology has proven to decrease scar tissue and reduce inflammation in ophthalmic procedures. The CONDUCT 1 trial will show whether similar outcomes are possible in chronic wounds, which could lead to fewer amputations in people with diabetes. — Kellen Owings

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