Researchers are beginning to test ExpressGraft on patients with diabetic foot ulcers.
Diabetic foot ulcers are common open sores or wounds that affect about 15 percent of diabetes patients, according to the American Podiatric Medical Association. Further, these foot ulcers are the reason for 85 percent of diabetes-related amputations.
These ulcers can develop from numbness in the foot, poor circulation, neuropathy, cuts and other trauma. The key to proper healing is to begin treatment as soon as possible, which will lower the risk of potential infection.
Researchers at Mallinckrodt, a global pharmaceutical company, have developed a skin tissue substitute that may be an effective way to treat patients with chronic, difficult-to-heal diabetic foot ulcers. The company confirmed this week that it enrolled the first patient in the initial study to test the safety and effectiveness of the treatment method.
The genetically-modified skin tissue, ExpressGraft™ C9T1, increases the levels of the cathelicidin host defense peptide, which encourages antimicrobial activity and promotes tissue growth and blood vessel formation for better wound healing.
The technologies in this skin substitute are similar to those in StrataGraft, which the researchers are currently in phase three of testing for severe burn wound treatment. Both are investigational products and still need to establish safety and efficacy before regulating them for standard use.
The initial phase one study, titled ExpressGraft™ C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers, is designed to test the skin substitute on human patients. The goal is to assess the safety and tolerability of the ExpressGraft on six participants, all of whom have Type 1 or Type 2 diabetes and foot ulcers that have lasted for at least four weeks.
Each study participant will receive one application of the skin tissue on his or her foot ulcer. The researchers will monitor for adverse effects, vital signs, blood chemistry and infection rates for a year after the treatment.
The researchers are currently recruiting participants for the clinical trial, and hope to complete the study by March 2019. If the study is successful, they will need to conduct two more phases of testing before applying for Food and Drug Administration approval.
If ExpressGraft proves to be beneficial for diabetic foot ulcers, it may also have the potential to treat other wound types.
Advanced Tissue is the nation’s leader in delivering specialized wound care supplies to patients, delivering to both homes and long-term care facilities.