Chronic Limb-Threatening Ischemia (CLTI) is the most severe form of peripheral arterial disease (PAD). It cuts off blood flow to the lower leg and foot, resulting in severe leg pain, wounds that won’t heal and, ultimately, amputation.
If your doctor has suggested amputation of your foot or lower leg to resolve non-healing wounds and pain, the PROMISE III study may offer you a treatment option.

About the Trial
The PROMISE III Trial is studying whether an investigational, minimally-invasive medical procedure that avoids major surgery can prevent foot or lower leg amputation and promote wound healing.
People with the following criteria may qualify to participate in the study:
- Adult patient
- May or may not have been diagnosed with Chronic Limb-Threatening Ischemia
- Severe leg pain, even when at rest
- Foot ulcers that are not healing
- Doctor’s recommendation to consider amputation of the foot or leg
- Not eligible for further conventional endovascular or surgical treatments to resolve artery blockage or CLTI





Participating Centers
Site Name | Site Location | Physician |
---|---|---|
Atrium Health | Charlotte, North Carolina | Gregory Stanley |
Baylor College of Medicine | Houston, Texas | Joseph Mills |
Boston Medical Center | Boston, Massachusetts | Alik Farber |
Coastal Carolina Surgical Associates | Wilmington, North Carolina | David Weatherford |
Dartmouth – Hitchcock Medical Center | Lebanon, New Hampshire | Richard Powell |
Harbor-UCLA Medical Center | Torrance, California | Mark Archie |
Massachusetts General Hospital | Boston, Massachusetts | Anahita Dua |
Ochsner Health Center | New Orleans, Louisiana | Zola N’Dandu |
Presbyterian Healthcare Services | Albuquerque, New Mexico | Steve Henao |
Prisma Health-USC Medical Group | Greenville, South Carolina | Sagar Gandhi |
San Lucas Hospital | Ponce, Puerto Rico | Jorge Martinez Trabal |
The Cardiac and Vascular Institute Research Foundation | Gainesville, Florida | Arthur Lee |
University Hospitals Harrington Heart & Vascular Institute | Cleveland, Ohio | Mehdi Shishehbor |
University of California, San Francisco | San Francisco, California | Michael Conte |
University of Florida | Gainesville, Florida | Ben Jacobs |
Vanderbilt University Medical Center | Nashville, Tennessee | Patrick Stone |
Yale University | New Haven, Connecticut | Cassius Chaar |


“There is an epidemic of lower limb amputation due to ischemia in the United States and LimFlow offers a very promising alternative for these patients to potentially heal their wounds and keep their feet.”
Mehdi H. Shishehbor, DO, MPH, PhD
Professor of Medicine,
Case Western Reserve University School of Medicine
University Hospitals Cleveland Medical Center
Case Western Reserve University
About LimFlow Therapy
Involves catheters, stents, an artery-to-vein crossing system and a unique device that disables valves in the vein, reversing flow in the vein so that blood can flow down to the foot
Designed to bypass blocked arteries in the leg and foot, preventing amputation, relieving pain and enabling wound healing
Minimally-invasive treatment