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PB125 + Exercise Rehabilitation for Peripheral Artery Disease

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)
Must not have
Patients with a bleeding disorder that would contraindicate the performance of a muscle biopsy, such as a history of clinically significant bleeding diathesis (i.e., Hemophilia A or B, Von Willebrand's Disease, or congenital Factor VII deficiency)
Women currently taking hormone replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, month 2, month 3, month 4

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a bleeding disorder that prevents muscle biopsy.
Select...
I am currently on hormone replacement therapy.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
~270

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,801 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
Oxidative Stress Research Study Groups: Exercise Rehabilitation+PB125, Exercise Rehabilitation with Placebo
Oxidative Stress 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
~43 spots leftby Jun 2028
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