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Peripheral Artery Disease: Early Intervention, Limb Preservation and Clinical Trials at UCSF

September is Peripheral Artery Disease (PAD) Awareness Month. More than 200 million people worldwide are living with PAD, including more than 20 percent of people age 65 and older1. PAD also disproportionately affects Black and Native American populations. Smoking, diabetes, high blood pressure and elevated cholesterol are important risk factors.

“The most advanced stage of PAD is chronic limb-threatening ischemia (CLTI),” said Michael S. Conte, MD, vascular surgeon and co-director of the UCSF Heart and Vascular Center. “For more than 10 years, the team at the UCSF Center for Limb Preservation has been evaluating and treating patients with advanced PAD in a single setting. We coordinate care so that it's not fragmented among different providers and offices.” 

At the center, vascular surgeons, podiatrists and nurse practitioners manage care and, depending on the case, bring in other specialists, including cardiologists, heart surgeons, interventional radiologists, endocrinologists, infectious disease experts and plastic surgeons. The team provides the most effective therapies to prevent amputation, treat PAD and reduce the risk of recurrent vascular problems.

“Many of our patients are diabetic, have kidney disease, are elderly or all of the above. The best results for those patients are obtained by providing combined, multi-specialty care at our Center for Limb Preservation,” said Conte. “Our team is totally committed to comprehensive and compassionate care to preserve limb function and maintain independent activity.”

Early intervention is crucial

Those with advanced PAD can lose valuable time waiting to see specialists at different locations. 

“Public and provider awareness about the early signs of PAD is essential,” Conte said. “A diabetic patient may have a small foot wound that's not healing. Another may complain of pain in the foot at rest. These are things that suggest a potentially serious problem,” he said. “Early recognition, timely referral, prompt assessment and effective treatment are key to saving as much of the foot as possible for these patients.”

“Some patients come to us with very advanced or acute presentations and need immediate hospitalization and aggressive treatments to get a successful outcome,” Conte added. “The stakes are higher when they present that way so it's much better when we can treat them at an earlier stage.”

Clinical trials at UCSF

UCSF is conducting clinical trials that may hold promise for patients whose PAD cannot be managed through conventional treatments.

One trial will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients who have non-healing ulcers of the lower extremity.

The PROMISE II Trial will study percutaneous deep vein arterialization for the treatment of late-stage CLTI. The trial will investigate the safety and effectiveness of the LimFlow System for creating an AV connection in the below-the-knee vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of CLTI in subjects ineligible for conventional endovascular or surgical limb-salvage procedures. 

“These trials are for patients who have no surgical or endovascular treatment option or who could benefit from an adjunctive treatment that is not currently part of the standard armamentarium,” said Conte.

Both trials are currently accepting new patients. 

Saving Frank’s foot

Frank, a 74-year-old man who had experienced worsening pain and wounds in his left foot over the course of five years, came to the UCSF Center for Limb Preservation for assessment and treatment. By that time, he was using a wheelchair due to his extreme foot pain and had reached what he described as a “point of desperation” when four of his toes began turning black.  

Frank’s course of treatment included multiple surgeries to treat an arterial blockage that had cut blood supply to his foot, as well as partial amputation of the affected toes. A year after his treatment, Frank is walking on his own without pain. “For me, going to UCSF was like going on a trip to Lourdes," he said, referring to the French town to which religious pilgrims travel in search of miracle cures for serious illnesses. "I had a miracle happen."


To learn more:

UCSF Center for Limb Preservation

Phone: (415) 353-2256 | Fax: (415) 353-2669

Refer a patient


Clinical trials:

Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects with Peripheral Ischemic Ulcers

The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia


1. Fowkes, F., et al. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol 14, 156–170 (2017).