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Nrf2 Activator

Vumerity for Peripheral Arterial Disease

Q: Are prospective patients still eligible to participate in this ongoing medical study?

According to information available on clinicaltrials.gov, at the moment, this particular trial is not seeking volunteers. It was initially listed on August 1st, 2024 and last amended on March 18th of the same year. Despite this trial being inactive in recruitment efforts currently, it's important to note that there are a total of 301 alternative studies actively looking for eligible participants.

Q: Can participants younger than 45 years old be considered for inclusion in this trial?

Only patients aged between 50 and 75 are eligible for this investigation. There are no trials available for individuals below the age of 18, with a substantial number of studies catered to those exceeding 65 years old.

Q: Which individuals are eligible to take part in this clinical research study?

To be eligible for participation in this research, individuals must have peripheral arterial disease and fall within the age range of 50 to 75. The trial is open to approximately 20 participants.

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.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Femoral and Popliteal Artery Blood Flow

Macrovascular Endothelial Function

Oxygen Transfer and Utilization

+1 more

Secondary outcome measures

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).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,714 Total Patients Enrolled

11 Trials studying Peripheral Arterial Disease

484 Patients Enrolled for Peripheral Arterial Disease

Song-Young Park, PhDPrincipal InvestigatorUniversity of Nebraska

2 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective patients still eligible to participate in this ongoing medical study?

"According to information available on clinicaltrials.gov, at the moment, this particular trial is not seeking volunteers. It was initially listed on August 1st, 2024 and last amended on March 18th of the same year. Despite this trial being inactive in recruitment efforts currently, it's important to note that there are a total of 301 alternative studies actively looking for eligible participants."

Answered by AI

Can participants younger than 45 years old be considered for inclusion in this trial?

"Only patients aged between 50 and 75 are eligible for this investigation. There are no trials available for individuals below the age of 18, with a substantial number of studies catered to those exceeding 65 years old."

Answered by AI

Which individuals are eligible to take part in this clinical research study?

"To be eligible for participation in this research, individuals must have peripheral arterial disease and fall within the age range of 50 to 75. The trial is open to approximately 20 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319339.

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