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Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease

NCT05648630 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-11-10

No results posted yet for this study

Summary

Physical activity is the most beneficial and cost-effective treatment for Veterans with PAD, however, issues with oxygen delivery and utilization dramatically impair exercise compliance. The cause of these oxygen delivery and utilization impairments is likely increased oxidative stress and inflammation. The proposed project will comprehensively examine the novel strategy of Nuclear Factor Erythroid-2-like 2 (Nrf2) activation using PB125, aimed at diminishing oxidative stress and inflammation, and thereby lessening the negative impacts of the disease. This therapeutic will be evaluated in isolation and in combination with exercise rehabilitation to determine if there is a complimentary benefit. The ultimate goal is to provide insight into a potential novel therapeutic treatment for this disease, therefore, improving exercise tolerance and quality of life in this growing population.

Conditions

  • Peripheral Artery Disease (D058729)
  • Oxidative Stress (D018384)
  • Inflammation (D007249)

Interventions

DIETARY_SUPPLEMENT

PB125

PB125 is a naturally-derived plant-based supplement that activates the Nuclear Factor Erythroid-2-like 2 (Nrf2) system to stimulate induction of endogenous antioxidants and anti-inflammatory pathways.

DIETARY_SUPPLEMENT

Placebo

A placebo will be used in combination with exercise rehabilitation allowing for a double blinded placebo controlled design.

BEHAVIORAL

Exercise Rehabilitation

A 12-week treadmill based supervised rehabilitation

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • David W. Wray, PhD · VA Salt Lake City Health Care System, Salt Lake City, UT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648630 on ClinicalTrials.gov