The Impact of Diabetes on REvascularization

Completed

Conditions studied: Peripheral Arterial Disease, Diabetes Mellitus

In brief

The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.

Key facts

Study ID

NCT03085524

Run by

Vanderbilt University Medical Center

People needed

215

Starts

2017-08-01

Expected to finish

2022-10-01

Last updated by the study team

2024-07-08

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 35 years or older
• Atherosclerotic, infrainguinal PAD
• CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain, consistent with Rutherford classes 4-6
• Candidate for either open or endovascular infrainguinal revascularization as judged by the treating investigators
• Adequate inflow into the index femoral artery
• Adequate popliteal, tibial, or pedal revascularization target
• Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
• Endovascular revascularization with a stent
• Surgical revascularization with a vein graft-

You may not qualify if…

• Femoropopliteal disease pattern consistent with TASC IIA
• Complete occlusion of the iliac artery
• Aortoiliac occlusive disease or severe common femoral artery disease
• Presence of a femoral, popliteal or tibial aneurysm of the index limb
• Life expectancy less than 2 years
• Deemed excessive risk for surgical bypass
• A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
• Renal dysfunction defined as MDRD eGFR ≤ 30ml/min/173 m2 at the time of screening
• Currently on dialysis or history of a renal transplant
• A documented hypercoagulable state
• Nonatherosclerotic occlusive disease
• Any prior infrainguinal revascularization
• Current immuno-suppressive medication, chemotherapy or radiation therapy
• Absolute contraindication to iodinated contrast

Where it is running

• Long Beach VA Medical Center — Long Beach, California, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• University Health System: LSU Health Sciences — Shreveport, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Michigan Vascular Center — Flint, Michigan, United States
• Michigan Heart - St. Joseph Mercy Health System — Ypsilanti, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Rutgers University Hospital — Newark, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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