Improving exercise rehabilitation for veterans with peripheral artery disease
Improving Exercise Rehabilitation Efficacy and Outcomes in Veterans With Peripheral Artery Disease: Targeting Oxidative Stress and Inflammation
NA · VA Office of Research and Development · NCT05648630
This study is testing if a new treatment combined with exercise can help veterans with peripheral artery disease feel better and improve their ability to exercise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Trial ID | NCT05648630 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of exercise rehabilitation for veterans suffering from peripheral artery disease (PAD) by addressing the underlying issues of oxidative stress and inflammation. It will investigate the activation of Nuclear Factor Erythroid-2-like 2 (Nrf2) using a therapeutic agent called PB125, both alone and in combination with exercise rehabilitation. The goal is to improve exercise tolerance and quality of life for veterans by reducing the negative impacts of PAD. The study will include patients aged 40 and older with clinically diagnosed femoropopliteal PAD.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 40 and older who have been clinically diagnosed with femoropopliteal peripheral artery disease.
Not a fit: Patients with bleeding disorders or complex atherosclerotic lesions that pose a risk with exercise rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve exercise tolerance and overall quality of life for veterans with peripheral artery disease.
How similar studies have performed: While the specific approach of using Nrf2 activation in this context may be novel, other studies have shown success in improving outcomes for patients with peripheral artery disease through various interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index \< 0.9) * Must understand the study requirements and be willing and able to sign an informed consent document * Patients with mild cognitive impairment (i.e., montreal cognitive assessment (MOCA) \<26) will be included but must have a responsible caregiver or spouse present during the informed consent * Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months Exclusion Criteria: * 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) * Patients with a complex atherosclerotic lesion such that withholding medication creates disproportionate risk * Women currently taking hormone replacement therapy * Any other condition or event considered exclusionary by the PI and faculty physician
Where this trial is running
Salt Lake City, Utah and 1 other locations
- University of Utah Dept of Vascular Surgery — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Jesse Craig, MBA — VA Salt Lake City Health Care System, Salt Lake City, UT
- Study coordinator: P Jon White, MD
- Email: Paul.White2@va.gov
- Phone: (801) 582-1565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, Oxidative Stress, Inflammation, inflammation, Skeletal muscle, Antioxidants