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Nrf2 Activator

Vumerity for Peripheral Artery Disease

Phase < 1
Waitlist Available
Led By Song-Young Park, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: before and after intervention. day 7: before and after intervention.

Summary

This trial aims to investigate whether a medication called diroximel fumarate (Vumerity) can help improve antioxidant capacity, reduce oxidative stress, and enhance vascular function and walking capacity in individuals

Who is the study for?
This trial is for individuals aged 50-75 with Peripheral Artery Disease (PAD) who experience leg pain during exercise and are not currently pregnant or nursing. They must not have severe PAD that has led to tissue loss, nor should they have kidney problems. Age-matched controls without PAD can also join if they don't have other diseases limiting exercise.
What is being tested?
The study tests whether a drug called Vumerity improves antioxidant capacity, reducing oxidative stress and enhancing blood vessel function and walking ability in people with PAD. Participants will receive either Vumerity or a placebo, and their vascular function and walking capacity will be evaluated through various medical tests.
What are the potential side effects?
While the specific side effects of Vumerity in this trial context aren't detailed here, common ones may include flushing, stomach pain, diarrhea, nausea; however individual reactions can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: before and after intervention. day 7: before and after intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: before and after intervention. day 7: before and after intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Femoral and Popliteal Artery Blood Flow
Macrovascular Endothelial Function
Oxygen Transfer and Utilization
+1 more
Secondary study objectives
Arterial Stiffness
Autonomic Nervous Activity
Circulating blood markers of Oxidative Stress and Antioxidants

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PAD: Vumerity intake, then PlaceboExperimental Treatment2 Interventions
Participants with peripheral artery disease (PAD) will receive a single dose of VUMERITY (diroximal fumarate, 462mg). After a minimum period of 7 days, they will then receive a single dose of the placebo (microcrystalline cellulose, 462 mg).
Group II: Control: Vumerity intake, then PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of VUMERITY (diroximal fumarate, 462mg). After a minimum period of 7 days, they will then receive a single dose of the placebo (microcrystalline cellulose, 462 mg).
Group III: Control: Placebo intake, then VumerityPlacebo Group2 Interventions
Participants will receive a single dose of placebo (microcrystalline cellulose, 462 mg). After a minimum period of 7 days, they will then receive a single dose of VUMERITY (diroximal fumarate, 462mg).
Group IV: PAD: Placebo intake, then VumerityPlacebo Group2 Interventions
Participants with peripheral artery disease (PAD) will receive a single dose of placebo (microcrystalline cellulose, 462 mg). After a minimum period of 7 days, they will then receive a single dose of VUMERITY (diroximal fumarate, 462mg).

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,364 Total Patients Enrolled
Song-Young Park, PhDPrincipal InvestigatorUniversity of Nebraska
4 Previous Clinical Trials
56 Total Patients Enrolled
~13 spots leftby Aug 2025