Effects of a medication on blood vessel function and walking ability in people with peripheral artery disease
Official title: Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease
Run by University of Nebraska · NCT06319339 · Data updated 2026-11-12
This study is testing if a medication called diroximel fumarate can help improve blood vessel function and walking ability in people aged 50-75 with peripheral artery disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT06319339 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50-75 with a diagnosis of Fontaine stage II-III peripheral artery disease and a history of exercise-induced claudication.
✕Probably not a fit
Patients with severe renal or hepatic dysfunction, or those outside the specified age range, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of diroximel fumarate (Vumerity) on improving vascular function and walking capacity in individuals with peripheral artery disease (PAD). Participants aged 50-75 with diagnosed PAD will receive either the medication or a placebo, and their vascular function will be assessed through various tests, including flow-mediated dilation and arterial stiffness measurements. The study aims to reduce oxidative stress and enhance endothelial reactivity, which is crucial for improving exercise tolerance in PAD patients.
Why it matters
Potential benefit: If successful, this study could lead to improved walking capacity and quality of life for patients suffering from peripheral artery disease.
How similar studies have gone: While the approach of using diroximel fumarate in this context is novel, previous studies have shown that antioxidant therapies can improve vascular function in similar patient populations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Nebraska - Omaha
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Gwenael Layec, PhD — University of Nebraska
- Study coordinator: Gwenael Layec, PhD
- Email: glayec@unomaha.edu
- Phone: 402-554-3224
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Fisetin to Improve Walking in Patients with Peripheral Arterial Disease
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A risk-prediction model is tested in adults with type 2 diabetes to see if a nursing plan based on the HAPA model can reduce peripheral artery disease in the legs.
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Antiplatelet-Only versus Antiplatelet plus Low-Dose Rivaroxaban after Heart Events
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.