The Impact of Diabetes on REvascularization



Status:Recruiting
Conditions:Peripheral Vascular Disease, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:35 - Any
Updated:4/6/2019
Start Date:August 1, 2017
End Date:August 31, 2020
Contact:Joshua A Beckman, MD
Email:joshua.a.beckman@vumc.org
Phone:615-322-2318

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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.

Peripheral artery disease is a condition defined by marked accumulation of atherosclerotic
plaque below the distal aorta that reduces lower limb arterial perfusion. Blood flow
reductions may be inadequate for exercising limbs and cause ischemic muscle pain, called
intermitted claudication, or, in severe cases, the reduction may be inadequate for basal
metabolism and cause pain at rest, ulceration, or gangrene. The presence of symptoms at rest
or tissue necrosis 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. The ageing
of the population and the increasing prevalence of diabetes mellitus ensures this population
will continue to grow in the foreseeable future. The impact of diabetes, however, is not
limited to PAD incidence. Diabetic patients represent a particularly vulnerable subset of PAD
patients and have a four-fold risk of CLI compared to non-diabetic patients. Indeed, in
previous studies of CLI, more than half of patients have diabetes. As a result, the
combination of diabetes and PAD accounts for more than half of non-traumatic amputations in
the United States. Diabetic patients often present with foot ulcerations as their first
manifestation of PAD and have challenging anatomy for revascularization. Failed vascular
reconstructions, both endovascular or surgical, often result in additional tissue loss and
transtibial amputations. Despite these challenges, the mechanisms of restenosis and the
impact of diabetes have not been well explored for both types of revascularization in
patients with CLI. The BEST-CLI trial is a multi-center, randomized, comparative
effectiveness trial comparing open surgical bypass therapy to endovascular therapy in CLI
patients with a composite clinical endpoint denoted as Major Adverse Limb Event free survival
(MALE-free survival). However, the BEST-CLI trial does not study the mechanisms by which
revascularization may fail. This proposal will extend the novel clinical work of the BEST-CLI
trial by studying the mechanisms of bypass vein graft and stent failure. The investigators
will adjudicate the mode of revascularization (vein graft or stent) in a central core
laboratory, measure systemic markers of diabetic dysmetabolism including inflammation,
insulin resistance, adverse adipokine expression, poor nutrition, and renal dysfunction, and
begin to study the association of these factors with graft failure. Indeed, no trial
conducted to date in either coronary or peripheral revascularization has determined the
mechanism of revascularization failure, the impact of diabetes, nor the relationship between
conduit patency and clinical outcomes. Therefore, this trial represents a unique opportunity
to investigate the mechanisms by which diabetes affects surgical and endovascular
revascularization procedures.

Inclusion Criteria:

- 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-

Exclusion Criteria:

- 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
We found this trial at
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Boston, Massachusetts 02118
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Gainesville, Florida 32610
(352) 392-3261
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Albany, New York 12208
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Albuquerque, New Mexico 87102
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Browns Mills, New Jersey 08015
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Chapel Hill, North Carolina 27599
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Charlottesville, Virginia 22903
(434) 924-0311
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Chicago, Illinois 60141
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Falls Church, Virginia 22042
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Flint, Michigan 98507
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
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1900 South Avenue
La Crosse, Wisconsin 54601
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Long Beach, California 90822
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Los Angeles, California 90033
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Madison, Wisconsin 53706
(608) 263-2400
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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Newark, New Jersey 07103
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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San Francisco, California 94121
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Shreveport, Louisiana 71130
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Valhalla, New York 10595
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West Des Moines, Iowa 50266
Phone: 515-633-3849
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Winnipeg, Manitoba
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Winston-Salem, North Carolina 27157
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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