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Vumerity for Peripheral Artery Disease

This study is looking at how a medication called Vumerity (diroximal fumarate) might help people with peripheral artery disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs, often causing leg pain during exercise. Researchers believe Vumerity could improve how your blood vessels work and your ability to walk by reducing something called oxidative stress. This study will compare Vumerity to a placebo (an inactive substance) to see if it improves blood vessel function and oxygen use in your legs. They will measure these changes before and after you take the medication on Day 1 and Day 7. They are looking for about 20 participants, aged 50-75, who have been diagnosed with PAD and experience leg pain with exercise.

Study design
This is an interventional study, meaning participants will receive either the study drug or a placebo. It plans to enroll 20 participants.
What's involved
Participants will have measurements taken before and after receiving the intervention on Day 1 and Day 7.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for measurements on Day 1 and Day 7.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06319339

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

Recruiting
EARLY_PHASE1Ages 50–75InterventionalTreatment
University of Nebraska
~20 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:VumerityPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Macrovascular Endothelial Function
Measured over Day 1: before and after intervention. Day 7: before and after intervention.
+3 more outcomes measured

Conditions

Peripheral Artery Disease
Peripheral Vascular Diseases
Peripheral Arterial Disease
Peripheral Arterial Occlusive Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Gwenael Layec, PhD · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

Gwenael Layec, PhD
[email protected]
402-554-3224
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

• 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
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

What this trial measures

  • Macrovascular Endothelial FunctionDay 1: before and after intervention. Day 7: before and after intervention.

    Macrovascular endothelial function will be measured non-invasively using the flow-mediated dilation (FMD) technique in the brachial and popliteal arteries using a Doppler ultrasound. These measures will be performed before and after vumerity or placebo on the first visit, and these measures will be performed before and after Vumerity or placebo on the second visit.

  • Oxygen Transfer and UtilizationDay 1: before and after intervention. Day 7: before and after intervention.

    Oxygen transfer and utilization will be measured as the near-infrared spectroscopy (NIRS) reoxygenation rate in the medial gastrocnemius after an arterial occlusion. These measures will be performed before and after Vumerity or placebo on the first visit, and these measures will be performed before and after Vumerity or placebo on the second visit.

  • Femoral and Popliteal Artery Blood FlowDay 1: before and after intervention. Day 7: before and after intervention.

    Femoral and popliteal artery blood flow will be measured in both legs using Doppler ultrasound. These measures will be performed before and after Vumerity or placebo on the first visit, and these measures will be performed before and after Vumerity or placebo on the second visit.

  • Walking capacityDay 1: before and after intervention. Day 7: before and after intervention.

    Physical walking capacity will be measured during the Gardner treadmill protocol. Participants will walk on a treadmill at 2.0 miles per hour (mph). Grade will began at zero and will be increased by two percent every two minutes. Participants unable to walk at least 2.0 mph begin walking at 0.5 mph and their speed is increased by 0.50 mph every two minutes until the participant reaches 2.0 mph. After reaching 2.0 mph, treadmill grade is increased by two percent every two minutes. Participants are asked to continue walking without stopping until they cannot continue because of leg symptoms, exhaustion, or other symptoms. These measures will be performed before and after Vumerity or placebo on the first visit, and these measures will be performed before and after Vumerity or placebo on the second visit.