Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on finding better ways to help Veterans with Peripheral Artery Disease (PAD) improve their ability to exercise. PAD can make it hard for blood to flow to the legs, which can cause discomfort and limit physical activity. Researchers believe that oxidative stress (an imbalance between free radicals and antioxidants in the body) and inflammation (swelling in the body) contribute to these problems. The trial will test a new treatment called PB125, which aims to reduce oxidative stress and inflammation. Participants will also engage in exercise rehabilitation to see if combining this treatment with exercise helps them feel better and improves their quality of life.

To join the trial, participants must be 40 years or older and have a diagnosed case of PAD. They should be able to understand the study requirements and sign a consent form, and those with mild cognitive impairment can participate if they have a caregiver present. However, individuals with certain medical conditions, such as bleeding disorders or complex heart issues, may not be eligible. Participants can expect to contribute to important research while potentially receiving new treatments that could help manage their symptoms and enhance their exercise tolerance.

Gender

ALL

Eligibility 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

Trial Officials