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PB125 + Exercise Rehabilitation for Peripheral Artery Disease

Q: Are any additional patients needed to participate in this research?

<p>According to the clinicaltrials.gov portal, this trial has ended its recruitment and is no longer actively seeking candidates. Initially posted on July 1st 2023, with a last update of December 8th 2022, many other trials are currently enrolling patients at present time - 574 in total.</p>

N/A

Recruiting

Led By Jesse Craig, MBA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months

Age 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index < 0.9)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, month 2, month 3, month 4

Awards & highlights

Study Summary

This trial explores a new treatment for Veterans with peripheral artery disease. It involves activating Nrf2 to decrease oxidative stress and inflammation, which may help them exercise and improve their quality of life.

Who is the study for?

This trial is for Veterans aged 40+ with Peripheral Artery Disease (PAD), who understand the study and can consent, or have a caregiver to assist. It's open to women not pregnant or likely to become so within six months. Excluded are those with bleeding disorders, complex atherosclerotic lesions requiring medication, or on hormone replacement therapy.Check my eligibility

What is being tested?

The trial tests PB125, a drug aimed at reducing oxidative stress and inflammation in PAD patients. It will be evaluated alone and alongside exercise rehabilitation to see if they work better together. The goal is improving exercise tolerance and life quality by addressing oxygen delivery issues.See study design

What are the potential side effects?

While specific side effects of PB125 aren't listed here, similar treatments may cause mild discomfort at the site of administration, potential allergic reactions, fatigue due to immune response modulation, as well as possible digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

Select...

I am 40 or older with diagnosed leg artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, month 2, month 3, month 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, month 2, month 3, month 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, month 2, month 3, month 4 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Exercise pressor response (EPR) Change

Intramuscular maximal bioenergetics (Vmax) Change

Six-minute Walk Test (6MWT) Change

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Exercise Rehabilitation+PB125Experimental Treatment2 Interventions

Participants will be assigned to the Exercise+Placebo or Exercise+PB125 rehabilitation interventions using block randomization.

Group II: Exercise Rehabilitation with PlaceboPlacebo Group2 Interventions

Participants will be assigned to the Exercise+Placebo rehabilitation interventions using block randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Rehabilitation

2015

N/A

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,119 Total Patients Enrolled

Jesse Craig, MBAPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT

Media Library

Exercise Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05648630 — N/A

Peripheral Artery Disease Research Study Groups: Exercise Rehabilitation+PB125, Exercise Rehabilitation with Placebo

Peripheral Artery Disease Clinical Trial 2023: Exercise Rehabilitation Highlights & Side Effects. Trial Name: NCT05648630 — N/A

Exercise Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05648630 — N/A

Frequently Asked Questions

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

Are any additional patients needed to participate in this research?

"According to the clinicaltrials.gov portal, this trial has ended its recruitment and is no longer actively seeking candidates. Initially posted on July 1st 2023, with a last update of December 8th 2022, many other trials are currently enrolling patients at present time - 574 in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease

2023. "Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05648630.

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