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The pain and never-healing foot lesions caused by peripheral arterial disease are bad enough.
But the most severe cases may leave patients with no option other than amputation.
Those are the patients Penn State Hershey Medical Center is seeking for a worldwide study that could result in new options for severe PAD.
"These are folks who have advanced peripheral vascular disease and no other treatment options are available to them but amputation," said Dr. David Han, the study's principal investigator at Penn State Hershey. "These folks are at the end of their rope."
In patients with PAD, blood flow is restricted because of a narrowing of arteries. Risk factors include high blood pressure, diabetes and high cholesterol.
Adults with PAD can develop critical limb ischemia, a condition that causes severe ulcers on their feet and legs. No drugs effectively treat the condition, and only a few treatments can delay or prevent the need for amputation.
The chance of developing PAD increases with age. It occurs in up to 20 percent of people over 65, according to the American Heart Association, and 8 million Americans overall.
PAD can be treated by using a patient's own vein to build a bypass for more blood flow to the legs. But some patients don't have a vein available for the surgery because it already has been used in a prior heart bypass.
"For those folks, what we did in my practice is watch and hope they get better, or, if they have infection or pain, amputate the foot or leg," Han said. "All we can offer in some cases is amputation."Han said amputation can be a relief for some people with advanced PAD because it gives back their lives after years of severe pain, bandaging limbs and taking medications.
"If a young person loses their leg, they can get over that. They can get around and function pretty well. For folks that have had chronic pain in their foot for years, they're pretty grateful when you amputate and take away the pain," he said.
But in the older population, amputation can mean immobilization.
"If you have someone who is more frail, they may at that point be confined to bed or a wheelchair for the rest of their lives," he said. "Sometimes amputating them is a major step forward, but not always."
Han said the study, taking place at 30 U.S. and 100 worldwide sites, will test an injectable drug's ability to promote blood vessel growth to improve circulation by inserting genes into a patient's muscle tissue.
"It's an injectable form of gene therapy, which makes people cringe because of the bad press gene therapy has gotten," Han said. "But this appears to be, at the least, very safe."
The study is being coordinated by the Paris-based pharmaceutical company Sanofi-aventis, according to a news release.
Study participants will undergo a series of four injections every two weeks at Penn State Hershey.
(429) (69) (20) (11) (6) (5) (3)"It's not painful, but it's not comfortable," Han said of the injection. "It's probably the equivalent of getting an immunization."
Participants must be over 50, diagnosed with severe peripheral vascular disease, have lesions or ulceration and have no other treatment available.
Patients who are enrolled in the study over the next few weeks will be reimbursed for travel expenses to Penn State Hershey and will receive the drug free of charge. Their health will be monitored for a year. Study results most likely will be published in about two years.
Because it is a "blind" or "masked" study, a computer will randomly select patients to receive the drug. Half the patients will receive a placebo.
"The only way we know the drug works is to compare its effect in people with the same condition," Han said.
"I think we're doing something here for people with no other alternatives. That's a meaningful thing to do."
For more information about the PAD study and to determine eligibility, call (888) 853-4656 or visit www.tamarisstudy.com.
E-mail: slindt@lnpnews.com
