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Understanding Peripheral Artery Disease with Near-Infrared Light

This study aims to better understand how blood flows and how your body uses oxygen in your legs if you have Peripheral Artery Disease (PAD). Researchers will use near-infrared light to see if PAD is caused by problems with oxygen delivery or how your cells use oxygen. They will also look at how these factors might affect how well treatments work for you. To join, you need to be at least 18 years old and have a doctor-confirmed diagnosis of PAD. The study will measure your quality of life, ankle-brachial index (a measure of blood flow), and walking ability over several months to see if the study's methods can help predict how you respond to treatment.

Study design
This is an observational study planning to include 120 participants. It is not specified if it is randomized or blinded.
What's involved
If you have PAD, you may have up to four study visits over 4-6 months. These visits will include questionnaires, walking tests, and MRI scans of your legs.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life, ankle-brachial index, and walking ability will be measured at the start of the study and again up to 26 weeks later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07313410

Using Near-Infrared Light to Better Understand Peripheral Artery Disease

Recruiting
Not specifiedAges 18+Observational
The University of Texas at Arlington
~120 participants
Updated 2026-01-02 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perceived Quality of life
Measured over Baseline and up to 26 weeks
+9 more outcomes measured

Conditions

Peripheral Artery Disease (PAD)

Explore related trials

Peripheral Artery Disease

Where it's being run

2 sites across 1 states
Texas2

Who to contact

Michael Nelson, PhD
[email protected]
8175130383
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cases, Aim 1
Cases, Aim 2
Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease

Exclusion

Cases, Aim 1
Cases, Aim 2
Controls 1) history of peripheral artery disease 2) overt cardiovascular disease (e.g. heart failure) 3) known pulmonary disease (excluding mild asthma) 4) current tobacco use 5) orthopedic or other physical limitations which would prevent data collection, 6) BP \>150/90 mmHg at screening 7) contraindications to MRI, including presence of a pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).

What this trial measures

  • Perceived Quality of lifeBaseline and up to 26 weeks

    Participants will complete a health questionnaire to gain a deeper understanding of their quality of life.

  • Ankle- Brachial IndexBaseline and upto 26 weeks

    The Ankle Brachial Index will be noninvasively assessed using the Smartdop XT device (Koven Technology, Inc.)

  • Walking abilityBaseline and upto 26 weeks

    Participants will complete a questionnaire to gain a deeper understanding of their walking ability

  • Functional performanceBaseline and upto 26 weeks

    Participants will be asked to walk as much as they can for six minutes (up and down a long hallway). Then, they will be asked to walk on a treadmill at 2 mph (3.2 km/h) at a grade of 10% for all as long as they can, or for a maximum of 10 minutes.

  • Steps takenBaseline and upto 26 weeks

    Participants will be asked to wear an activity monitor on their wrist to track the number of steps they take each day for up to 6 months. A member of the study team will contact them by phone, email or text message each week to remind them to complete a log book of their daily activity.

  • Oxygen level of leg musclesBaseline and upto 26 weeks

    Participants will be asked to perform exercise with their lower leg (affected leg, if they have peripheral artery disease) while they are in an MRI. A small plastic device (about the size of a match box) will also be placed on their lower limb. This device will measure the oxygen level of their leg muscles using near-infrared light.

  • Body compositionBaseline and up to 26 weeks

    An MRI will be performed across the upper and lower body to measure muscle size, muscle quality, adiposity and body structure.

  • Leg Exercise MRIBaseline and upto 26 weeks

    Participants will be asked to perform exercise with their lower leg (affected leg, if they have peripheral artery disease) while they are in an MRI. The MRI will be used to measure the blood flow in leg and the oxygen level of the blood in their veins.

  • Lower Leg Ischemia-ReperfusionBaseline and up to 26 weeks

    A blood pressure cuff will be inflated around the upper leg for 5 minutes before being released. Leg blood flow and vein oxygen saturation will be measured throughout.

  • Leg muscle size and qualityBaseline and up to 26 weeks

    An MRI of the leg will be performed to measure muscle size and tissue characteristics.