Newswise — Ochsner Health is one of 20 sites in the U.S. participating in the PROMISE II clinical trial, which was recently published in the New England Journal of Medicine. The study explored if a minimally invasive treatment for patients with a severe form of peripheral artery disease who were facing amputation could keep their leg and improve their lives.
Chronic limb-threatening ischemia, or CLTI, is the end stage of peripheral artery disease and occurs when arteries that carry blood down to the lower leg and foot become blocked, preventing blood and oxygen from flowing to the area. As a result, people with CLTI often experience chronic pain, festering, non-healing wounds, and severe infections. The disease is closely linked to diabetes, and often diabetics will have no option today but amputation of the affected foot or lower leg. By participating in this clinical trial, we wanted to determine if there was a way for these patients to keep their leg.
The study found that 76 percent of patients were able to keep their leg at least six months after undergoing transcatheter arterialization of the deep veins (TADV) using the LimFlow System, a minimally invasive approach designed to bypass blocked arteries in the leg and rush blood back into their foot through the veins. All patients coming into the study had non-healing wounds on their feet and/or legs; yet, six months after treatment, wounds were completely healed or in the process of healing for every three out of four patients. The therapy also significantly reduced patient pain. Our vascular team will continue to follow the progress of these patients.
“This study allowed us to bring new hope to our patients who today would have no alternative but amputation. This therapy is potentially game-changing for patients with severe vascular disease who are often diabetics, and who want to keep their leg, heal their wounds, and get back to the things they love in life,” said Dr. Zola N’Dandu, cardiologist and principle investigator for the PROMISE II clinical trial at Ochsner Health.
###
RSS