Peripheral Artery Disease (PAD)NCT07313410
Using Near-Infrared Light to Better Understand Peripheral Artery Disease
An observational study of Peripheral Artery Disease (PAD), run by The University of Texas at Arlington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases- 80 individuals with PAD. Controls- 40 healthy volunteers, of similar age, sex, and ethnicity as the PAD cases.
Who may be able to join
- Cases, Aim 1
- 18 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
Show all 9Show fewer
- Cases, Aim 2
- 1) completed Aim 1
- Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas at Arlington
Arlington, Texas, 76010
Rajvi Shah, 2147557
- Not yet recruiting
University of Texas Arlington
Arlington, Texas, 76019
Rajvi Shah, MPH, 2147557343, rajvi.shah@uta.edu
Michael Nelson, PhD
About this study
Official title: Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease
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.
Read the 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)
- Keywords
- Exercise MRI, Functional Performance, Ankle-Brachial Index, Questionnaires, MRI, Peripheral Artery Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Individuals without PAD | |
| Cases with PAD | Individuals with PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Quality of life
Participants will complete a health questionnaire to gain a deeper understanding of their quality of life.
Measured: 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.)
Measured: Baseline and upto 26 weeks
Walking ability
Participants will complete a questionnaire to gain a deeper understanding of their walking ability
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Nelson, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313410
- Sponsor's protocol ID
- 2025-0414
- Other IDs
- 25CSA1432263
- Status last verified
- Dec 2025
- First submitted
- 18 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07313410
- Acronym / sponsor ID
- 2025-0414
- Conditions
- Peripheral Artery Disease (PAD)
- Keywords
- Exercise MRI, Functional Performance, Ankle-Brachial Index, Questionnaires, MRI, Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Individuals without PAD |
| Cases with PAD | – | –Individuals with PAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases- 80 individuals with PAD. Controls- 40 healthy volunteers, of similar age, sex, and ethnicity as the PAD cases.
Key inclusion criteria (9 listed)
- Cases, Aim 1
- Cases, Aim 2
- 1) completed Aim 1
- Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived Quality of life
Time frame: Baseline and up to 26 weeks
Participants will complete a health questionnaire to gain a deeper understanding of their quality of life.
Ankle- Brachial Index
Time frame: Baseline and upto 26 weeks
The Ankle Brachial Index will be noninvasively assessed using the Smartdop XT device (Koven Technology, Inc.)
Walking ability
Time frame: Baseline and upto 26 weeks
Participants will complete a questionnaire to gain a deeper understanding of their walking ability
Functional performance
Time frame: Baseline 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 taken
Time frame: Baseline 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 muscles
Time frame: Baseline 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 composition
Time frame: Baseline 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 MRI
Time frame: Baseline 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-Reperfusion
Time frame: Baseline 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 quality
Time frame: Baseline and up to 26 weeks
An MRI of the leg will be performed to measure muscle size and tissue characteristics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease (PAD), run by The University of Texas at Arlington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Nelson, PhD (8175130383, michael.nelson3@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Quality of life (time frame: Baseline and up to 26 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.