- The Washington Times - Wednesday, June 4, 2008

Ron Frazier of Annandale is a surprisingly happy man. Consider that, at age 69, he has diabetes,

congestive heart failure and an open foot wound. In addition, the toes on his left foot have been amputated, the result of circulatory problems caused by the diabetes, and he is facing a 20 percent chance of a second amputation if an infection finds its way into the bones of his right foot.

“No part of my body operates correctly,” he says, smiling. “And yet it works.”

He smiles even after months on and off with a wheelchair and crutches. He goes to his office daily - he is a land developer, so he isn’t too busy these days, he jokes - and invested $1,000 in hand controls for his car so he could stay on the road.

His wife, Jan Frazier, the constant helpmate he calls alternately “my worrier” and “my savior,” is known by Georgetown University Hospital personnel as “the hawk.” She watches attentively whenever he goes for surgery or treatment at the hospital’s Center for Wound Healing, a department known for its ability to salvage diseased limbs.

Mr. Frazier’s quarter-size foot wound - a plantar heel ulcer in medical lingo - has been his scourge ever since a blister rubbed open as he played in two golf tournaments in June 2005. As a diabetic with weight problems, Mr. Frazier could risk getting gangrene again - death of tissue caused by faulty circulation - unless the wound is healed.

“Ulcers are an external manifestation of an internal problem. One in five diabetic patients with an ulcer gets an amputation,” says Kara S. Couch, a nurse practitioner at the wound center. “Diabetes is going to bankrupt this country,” she adds ominously, referring to the rapid increase in the number of diabetes cases, mainly type 2, which is related to obesity.

Therapy offered patients such as Mr. Frazier these days includes a bioengineered skin product applied like a bandage to encourage more rapid healing that might prevent the need for surgical amputation. Called an apligraf after the normal skin graft that often accompanies treatments for stubborn burns and sores, the FDA-approved agent has been used on Mr. Frazier three times. He also has been treated in a hyperbolic chamber, which delivers oxygen to promote peripheral vascular regrowth and increase blood flow.

Before apligraf, pigskin was the substance used so skin would not grow over the wound, which healed from the inside out, until healing was complete.

The newest method, known for 10 years, uses foreskin taken from newborn boys during circumcision and given voluntarily to donation programs in select teaching hospitals by mothers whose blood and family history is screened carefully. Nutrients - collagen from cows raised in controlled herds - encourage the human fibroblasts in the skin to reproduce.

“One little piece can cover a football field. In 10 years we have only used 11 [foreskins] and treated several hundred thousand patients,” says Geoff MacKay, chief executive of Oranogenesis Inc. of Canton, Mass., the manufacturer. “Apligraf was the first living cell therapy to be approved by the [Food and Drug Administration] for chronic wounds,” he notes.

The wound first is cleaned extensively to remove dead skin and any bacteria. Adhesive tape keeps the apligraf patch in place along with a portion of gel and a spongelike bandage containing silver, a natural antimicrobial agent. Within days, the apligraf starts to fuse with the patient’s own skin tissue to rebuild the deep part of the wound. Each treatment lasts about four weeks. Without apligraf, dressings would have to be changed daily to discourage infection.

“You traumatize the healthy skin this way, and it starts healing; it stimulates blood flow and vessel growth,” explains Dr. John Steinberg, co-director of the hospital’s wound center, which takes a team approach - five medical specialists and two dedicated operating rooms - to treating its patients.

Skin grafts, in which a piece of the patient’s own skin is removed surgically to be used as a healing agent, is less desirable because it leaves a second open wound on the body vulnerable to infection.

“Right now, apligraf is the best we’ve got because of its unique ability to deliver human living cells. That decreases a patient’s exposure to risk,” Dr. Steinberg says.

The likely future for this kind of therapy, he notes, includes its potential for helping close wounds from a surgical procedure for skin cancer and in some forms of plastic surgery reconstruction.

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