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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: before and after intervention. day 7: before and after intervention.

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).

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