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    Skin-like Tissue Appears Promising

    Bioengineered skin-like tissue, grown from human foreskin, promotes healing of foot ulcers in people with diabetes who do not respond to conventional wound therapies. The only living, or viable, two-layered graft skin approved by the Federal Drug Administration, Graftskin (Apligraf ®) has been shown to close the most stubborn wounds, even those more than a year old.

    Presenting the results of a study on the effectiveness of Graftskin in treating foot ulcers at the American Diabetes Association's 60th Scientific Sessions in San Antonio, Aristidis Veves, M.D., D.Sc., an endocrinologist and research director of the Joslin Beth Israel Deaconess Foot Center in Boston, Massachusetts, notes that healing occurred within 12 weeks of applying the tissue in 56 percent of the 208 patients treated. Currently, the success rate is even higher at Beth Israel's wound care center, with 75 percent of patients responding to this new treatment.

    Dr. Veves explains that there are three stages of wound healing: inflammatory (scabbing process begins), proliferative (new tissue forms), and maturation (scar turns white). Growth factor cytokine production--proteins and enzymes that form new tissue--goes up and down with each phase of healing. "Some diabetics can't move to the second phase, when collagen formation takes place," he says, noting that the entire process takes about a year. Researchers are not sure how Graftskin works, but Dr. Veves speculates that it stimulates action of cytokines, which causes new skin to form.

    With Graftskin, a 7 1/2-centimeter patch of tissue is sutured over the wound. Within a week, a firm protective layer forms. By the end of a month the wound shrinks and the central portion closes. Another skin graft is applied to the remaining area of the ulcer at 12 weeks, and the healing process begins again. During the study, Graftskin was applied on average 3.9 times.

    Dr. Veves emphasizes that this is an adjunct treatment to standard wound care for people with chronic ulcers only--ulcers that won't heal. This is not a magic bullet--it's not a replacement for conventional wound care therapies," he says, adding that the wound must be surgically cleaned, free of infection, and relieved of pressure by offloading with proper sandals before applying Graftskin. He notes that vascular bypass surgery may also be required for individuals with poor circulation.

    "The results of the study using Grafskin are very promising, says Dr Veves. "The study shows that Graftskin is effective in treating diabetic foot ulcers--wounds that if left open could result in serious complications, including infection, hospitalization, and even amputation. It's expensive though, this treatment should be kept for those who fail to heal with conventional therapies," he stresses, noting that application of Graftskin costs about $1,000.

    About 600,000 people with diabetes develop foot ulcers each year in the United States alone. An estimated 60-70 percent of people with diabetes have nerve damage, which causes numbness. Something as simple as a pebble in a shoe can cause a wound and the formation of a foot ulcer. According to the ADA, diabetes is the most frequent cause of lower-limb amputation, with 56,000 amputations performed on people with diabetes each year.

    "This is very exciting--it's a first step toward creating human organs from living tissue, says Dr. Veves, noting that a single foreskin can provide enough Graftskin to cover a football field. Graftskin has been approved by the FDA for treating venous leg and foot ulcers, however, researchers are looking at other uses for it, such as to treat burns and bedsores.



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