NCT07313410

Using Near-Infrared Light to Better Understand Peripheral Artery Disease

Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: The University of Texas at Arlington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to better understand how blood flows and how oxygen is utilized in the lower limbs of people who suffer from peripheral artery disease. This study will also assess how these factors affect treatment outcomes. Specific aims include: Aim 1: Utilize BB-NIR-DCS to differentiate PAD patients experiencing primary oxygen delivery limitations from those suffering from mitochondrial dysfunction. Aim 2: Test the efficacy of BB-NIR-DCS at predicting individual responses to vascular intervention.

Detailed description

Subjects that do not have peripheral artery disease will complete the study procedures up to two times (baseline and follow-up at 1-2 months). Subjects diagnosed with peripheral artery disease may be asked to complete the study procedures up to 4 separate times (baseline, follow-up at 1-2 weeks, 1-2 months, and 4-6 months). The investigators will work with them to schedule each visit. All participants will provide informed consent prior to participating in the study. The screening procedures will include collecting information about health history, age, sex, race/ethnicity, height, weight, and reasons one should not undergo an MRI or exercise. The laboratory procedures will include questionnaires about quality of life and walking ability, Ankle- Brachial Index, functional performance measures (treadmill walking and six minute walk distance), wearable activity monitor and activity log, and lower limb MRI with muscle perfusion and oxygenation measures at rest and in response to physiologic provocation (ischemia-reperfusion and exercise). Investigators may ask subjects to return on a separate day to repeat part, or all, of the study procedures depending on image quality and/or equipment performance.

Conditions

• Peripheral Artery Disease (PAD)

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

2 sites across 1 country: United States