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New Options

Are you facing amputation
of your leg or foot?

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
U.S. PROMISE III Clinical Trial

Participating Centers

Site NameSite LocationPhysician
Atrium HealthCharlotte, North CarolinaGregory Stanley
Baylor College of MedicineHouston, TexasJoseph Mills
Boston Medical CenterBoston, MassachusettsAlik Farber
Coastal Carolina Surgical AssociatesWilmington, North CarolinaDavid Weatherford
Dartmouth – Hitchcock Medical CenterLebanon, New HampshireRichard Powell
Harbor-UCLA Medical CenterTorrance, CaliforniaMark Archie
Massachusetts General HospitalBoston, MassachusettsAnahita Dua
Ochsner Health CenterNew Orleans, LouisianaZola N’Dandu
Presbyterian Healthcare ServicesAlbuquerque, New MexicoSteve Henao
Prisma Health-USC Medical GroupGreenville, South CarolinaSagar Gandhi
San Lucas HospitalPonce, Puerto RicoJorge Martinez Trabal
The Cardiac and Vascular Institute Research FoundationGainesville, FloridaArthur Lee
University Hospitals Harrington Heart & Vascular InstituteCleveland, OhioMehdi Shishehbor
University of California, San FranciscoSan Francisco, CaliforniaMichael Conte
University of FloridaGainesville, FloridaBen Jacobs
Vanderbilt University Medical CenterNashville, TennesseePatrick Stone
Yale UniversityNew Haven, ConnecticutCassius Chaar
U.S. PROMISE III Clinical Trial

“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

Trial FAQs