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 |
---|---|---|
Atlanticare | Atlantic City, NJ | Nicholas Petruzzi |
Atrium Health | Charlotte, NC | Gregory Stanley |
Boston Medical Center | Boston, MA | Alik Farber |
Dartmouth – Hitchcock Medical Center | Lebanon, NH | Richard Powell Jocelyn Beach |
Hospital of the University of Pennsylvania | Philadelphia, PA | Elizabeth Genovese |
Icahn School of Medicine at Mount Sinai | New York, NY | Prakash Krishnan |
Massachusetts General Hospital | Boston, MA | Anahita Dua |
Presbyterian Healthcare Services | Albuquerque, NM | Steve Henao |
Rush University Medical Center | Chicago, IL | Sreekumar Madassery |
The Cardiac and Vascular Institute | Gainesville, FL | Arthur Lee |
University Hospitals Cleveland Medical Center | Cleveland, OH | Mehdi Shishehbor |
UCSF Medical Center | San Francisco, CA | Michael Conte Shant Vartanian |
University of Florida | Gainesville, FL | Benjamin Jacobs |
University of Massachusetts Chan Medical School | Worcester, MA | Douglas Jones |
UT Southwestern Medical Center | Dallas, TX | Michael Siah |
Vanderbilt University Medical Center | Nashville, TN | Daniel Clair |
Washington University | St. Louis, MO | Patrick Geraghty |
Weill Cornell Medicine | New York, NY | Brian DeRubertis |
Yale University | New Haven, CT | Cassius Iyad Ochoa 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