Using Near-Infrared Light to Better Understand Peripheral Artery Disease

NCT07313410 | Recruiting

• 2 other identifiers: 2025-041425CSA1432263
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Artery Disease (PAD)

Keywords

Exercise MRI; Functional Performance; Ankle-Brachial Index; Questionnaires; MRI; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (10)

• Perceived Quality of life

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

  Baseline and up to 26 weeks

• Ankle- Brachial Index

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

  Baseline and upto 26 weeks

• Walking ability

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

  Baseline and upto 26 weeks

• Functional performance

  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.

  Baseline and upto 26 weeks

• Steps taken

  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.

  Baseline and upto 26 weeks

• Oxygen level of leg muscles

  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.

  Baseline and upto 26 weeks

• Body composition

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

  Baseline and up to 26 weeks

• Leg Exercise MRI

  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.

  Baseline and upto 26 weeks

• Lower Leg Ischemia-Reperfusion

  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.

  Baseline and up to 26 weeks

• Leg muscle size and quality

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

  Baseline and up to 26 weeks

Study Arms (2)

Healthy Controls

Individuals without PAD

Cases with PAD

Individuals with PAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases- 80 individuals with PAD. Controls- 40 healthy volunteers, of similar age, sex, and ethnicity as the PAD cases.

You may qualify if:

• Cases, Aim 1
• or older
• willing to participate under the conditions described in the informed consent form (ICF)
• eligible to sign the ICF
• established diagnosis of PAD confirmed by a physician
• able to comply with the study requirements
• Cases, Aim 2
• \) completed Aim 1
• Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease

You may not qualify if:

• Cases, Aim 1
• Ankle-Brachial Index \>0.9 or \<0.4
• isolated disease in aorta/iliac vessels
• unstable angina or myocardial infarction in past 12 months
• orthopedic or other physical limitations which would prevent data collection
• 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
• Cases, Aim 2
• unstable angina or myocardial infarction in past 12 months
• orthopedic or other physical limitations which would prevent data collection
• 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).
• 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).

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (2)

University of Texas at Arlington

Arlington, Texas, 76010, United States

RECRUITING

University of Texas Arlington

Arlington, Texas, 76019, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Serum will be retained for up to 2 years after study completion.

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Michael Nelson, PhD

CONTACT

8175130383; michael.nelson3@uta.edu

Rajvi Shah, MPH

CONTACT

2147557343; rajvi.shah@uta.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: January 2, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (2)