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Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

University of Nebraska · NCT06319339

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
20
US sites recruiting
1
Study start
November 14, 2024
Record last updated
June 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vumerity; Placebo

Conditions: Peripheral Artery Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Nebraska - Omaha

    Omaha, NE 68182

    Site contact: Gwenael Layec, PhD · 402-554-3224 · glayec@unomaha.edu

Study contacts (from the official record)

  • Gwenael Layec, PhD · 402-554-3224 · glayec@unomaha.edu
  • Cody Anderson · codypanderson@unomaha.edu
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Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg… (NCT06319339) | Bored Studies