Omaha, NENCT06319339Now EnrollingIRB Ready

Peripheral Artery Disease Clinical Trial in Omaha, NE

Access cutting-edge peripheral artery disease treatment through this clinical trial at a research site in Omaha. Study-provided care at no cost to qualified participants.

Sponsored by University of Nebraska

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Expert Care in Omaha

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related peripheral artery disease treatment provided free

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Check if you qualify for this peripheral artery disease clinical trial in Omaha, NE

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Why Participate?

  • No-Cost Study Care

  • Local to Omaha

    Convenient for NE residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Omaha site if eligible
  4. 4Begin participation

About This Peripheral Artery Disease Study in Omaha

Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.

Sponsor: University of Nebraska

Who Can Participate

Inclusion Criteria

Peripheral artery disease (PAD) participants:
Able to provide written informed consent
50-75 years of age
Diagnosed as Fontaine stage II-III
History of exercise-induced claudication
Females must be postmenopausal (cessation of menses for \> 24 months)
Normal renal function (serum creatinine-estimated glomerular filtration rate \>= 60 mL/min) or evidence of stable renal function within the last 6 months
Normal hepatic function (alanine transaminase \< 87.5 U/L, alkaline phosphatase \< 260 U/L, total bilirubin 1.8 mg/dL) or evidence of stable hepatic function within the last 6 months
Complete blood count:
Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months
Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months Age-matched control participants:
Able to provide written informed consent
50-75 years of age
No evidence of peripheral occlusive disease (ankle-brachial index \> 0.90)
Females must be postmenopausal (cessation of menses for \> 24 months)
Normal renal function (serum creatinine-estimated glomerular filtration rate \>= 60 mL/min), or evidence of stable renal function within the last 6 months
Normal hepatic function (alanine transaminase \< 87.5 U/L, alkaline phosphatase \< 260 U/L, total bilirubin 1.8 mg/dL ), or evidence of stable hepatic function within the last 6 months
Complete blood count:
Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L
Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months

Exclusion Criteria

Peripheral artery disease (PAD) participants:
• Pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD)
Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
Limited walking capacity from conditions other than PAD
No physical exam to assess exercise limitations in the past year
Currently pregnant or nursing
Blood work and medical history NOT demonstrating:
Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L),
Diagnosis of multiple sclerosis or psoriasis
Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc.
Concomitant use of dimethyl fumarate
Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY
Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)
Complete blood count NOT within ranges:
Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L Age-matched control participants:
Positive diagnosis of PAD
No physical exam to assess exercise limitations in the past year
Any exercise limitations as determined at last physical exam
Limited walking capacity from musculoskeletal injury
Currently pregnant or nursing
Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
Hepatic function not within normal ranges (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L)
Complete blood count NOT within ranges:
Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Omaha?

Yes, this clinical trial (NCT06319339) has an active research site in Omaha, NE that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Peripheral Artery Disease Treatment Options in Omaha, NE

If you're searching for peripheral artery disease treatment options in Omaha, NE, this clinical trial (NCT06319339) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Omaha research site is actively enrolling participants for this clinical trial. You'll receive care from experienced peripheral artery disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all peripheral artery disease clinical trials near you to find additional studies recruiting in your area.

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