Exciting New Treatment

People with non-healing diabetic foot ulcers and certain chronic leg ulcers are benefiting from a unique new treatment at the HYPERBARIC/WOUND TREATMENT CENTER.

“Apligraf® is a living, skin-like substance that is grafted over certain types of chronic, open wounds. It is grown from human skin cells in a laboratory,” explained a board-certified emergency physician associated with the Hyperbaric/Wound Treatment Center. “Like human skin, it has an outer protective layer of cells and an inner layer containing substances that are important in the healing process,” he explained. Healing is promoted by the ability of these cells to provide structural support, growth factors and specialized proteins to the chronic wound. Apligraf is the only product of its type that has been approved by the U.S. Food and Drug Administration for the treatment of diabetic foot ulcers and venous leg ulcers.

There are almost 20 million diabetics in the United States. Each year, five per cent of diabetic patients develop foot ulcers. Many diabetics require limb amputation, and the majority of them have foot ulcers as a contributing factor.

Diabetes damages nerves causing numbness of the feet. Most people don’t look at the bottom of their feet, and therefore don’t know when there is a problem. Blisters, cuts and ulcers may occur without being noticed. These ulcers are very prone to infection, difficult to heal, and quick to recur. Without treatment, they can lead to amputation. Half of all diabetics who undergo amputation do not survive five years. Conventional treatment involves cutting away dead tissue, administering antibiotics for infection, controlling blood sugar, providing appropriate topical wound care and eliminating pressure. Unfortunately many of these wounds fail to heal even with the best of care. It is these “chronic wounds” which may lead to infection and amputation. “Any diabetic foot wound that doesn’t heal within a month is cause for concern,” Miller said. Foot ulcers are the most common reason for hospitalization of people with diabetes.

If progress has stalled after four weeks, complete healing is unlikely. Apligraf is helpful in healing these challenging wounds and is easy and painless to use. Unlike conventional skin grafts, surgery is not required, and there is no painful donor site which can be as difficult to heal as the wound itself. The procedure can be done in an outpatient clinic. “In a recent clinical trial, 56 percent of diabetic foot ulcers treated with Apligraf were completely healed, as compared to 39 percent treated with traditional therapies,” Dr. Newton noted. Faster healing was also observed. The average time to heal a wound with Apligraf was 65 days while conventional therapy required 90 days. Rapid and more complete healing reduced the chance of bone infection from 10.4 % to 2.7%, and the amputation rate from 15.6% to 6.3% in those patients who received an Apligraf. Ninety-two percent of the ulcers successfully closed with Apligraf remained healed. This treatment was not only better for the patients, but also more cost effective because of shorter time to heal and lower amputation rates.

Apligraf does not function in the same way as a skin graft, it does more. It converts a stagnant wound into an acute wound and stimulates and augments the wound’s intrinsic healing pathways. For many patients, applying Apligraf to a wound plays a vital role in the healing process. It improves mobility and quality of life, helps control infection, and can even prevent the need for amputation.

Patients with venous stasis ulcers also are benefiting from Apligraf treatment at the MMC Wound Treatment Center. Venous stasis ulcers are generally located on the inner part of the leg, just above the ankle. They are common in people who have poor venous circulation in their legs, a history of blood clots in the veins, a history of swelling in one or both legs, or long-standing varicose veins. Venous leg ulcers affect between 500,000 to 600,000 people in the United States every year. They account for ninety percent of all leg ulcers. These ulcers can be very painful and treatment is expensive, especially when time to healing is prolonged. Conventional therapy often doesn’t work. Only 50% to 60% of patients are healed with standard compression therapy and wound care. If a wound is not progressing after four weeks of therapy, an Apligraph may be indicated.

Apligraf achieved closure in more patients with venous ulcers of more than one month’s duration at 24 weeks than compression therapy (Unna’s boot) alone, 57% vs. 40%. In patients with ulcers present for more than a year, Apligraf plus compression therapy was more than twice as effective in achieving complete wound closure by week 24. In a large multicenter study of patients with wounds which had not healed after more than a year of standard treatment, 74% experienced complete wound closure with a median time to heal of less than two months after Apligraf therapy. Apligraf closes more wounds faster, eliminating the need for additional costly treatment. Success rates as high as 90% have been reported. Improved wound healing allows patients to return to a full life more quickly.