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About Holy Name Medical Center About Holy Name Medical Center

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  • Medical Center Operator

  • 201-833-3000

  • Physician Referral Service

  • 877-HOLY-NAME (465-9626)

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  • 201-833-3300

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  • 201-833-3187

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  • 201-833-7040

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  • 201-833-3352

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For general questions or comments, email info@holyname.org


For More Information:

201-541-6312
Clinical Research

info@holyname.org

STOP–PAD Clinical Trial – A Groundbreaking Study on Preventing Limb Amputation

Severe peripheral artery disease (PAD), a narrowing of the arteries due to the buildup of plaque, can lead to limb amputation. Individuals with advanced disease may be eligible to participate in a groundbreaking clinical study being conducted at Holy Name Medical Center to help avoid this devastating outcome.

The study, called STOP–PAD, is testing whether JVS–100, a biologic gene therapy that activates natural repair processes, helps the body mobilize specialized cells that heal damaged tissue and develop new blood vessels. Potentially, this will allow healing to occur more effectively compared to restoring blood flow alone. The two–year study, conducted at 24 sites across the U.S. and in its second year, has already shown positive results in treated patients and has been fast–tracked by the Food and Drug Administration (FDA).

Holy Name's Interventional Radiologists, led by John Rundback, MD, Medical Director of the Interventional Institute at the Medical Center, perform minimally invasive procedures that clear plaque from the clogged arteries. After the procedure, an injection of the biologic, JVS–100, is then given near the site of the blockage. Another injection is given three months later.

"We are excited to be part of this ground–breaking trial," Dr. Rundback said. "The use of an advanced biologic is an exciting and innovative step forward in the field and may establish a new standard of care for treating diabetics and other patients with difficult and leg–threatening vascular wounds who otherwise face the possibility of major amputation."

Severe PAD causes pain and prevents wounds from healing, sometimes turning the toes, foot or even whole sections of the leg black with gangrene. Among the Holy Name patients who have seen major improvements are two men in their 70s, Paul Quinn and Bob O'Brien.

Paul has diabetes and had poor circulation in his legs and feet. He developed an infection in one of his toes that spread, and eventually he needed all the toes on his right foot to be surgically removed. Although he could still walk, he later started experiencing pain in his left calf and was afraid he would need additional surgery. He participated in the study more than a year ago and within two months, he was walking without pain. The chronic wound on his foot has healed.

"The results have been excellent," Paul said. "The blood pressure in my legs has improved and I have no more pain when I walk."

Bob also has diabetes and had pain in his legs when he walked, but didn't think much about it. Then last summer, he was hospitalized after one of his toes became swollen and turned black with an infection. Eventually, the toe was amputated. But Bob still suffered with poor circulation in his legs and faced ongoing pain and the possibility of more surgeries. After his participation in the study, his circulation has improved significantly and wounds are healing faster.

Holy Name has enrolled the most patients in the study, which will involve 120 nationwide. The clinical trial follows a previous study with 180 patients that saw a majority of patients experience less pain, a reduction in ulcer size and improvement in overall feeling of wellness.