NCT07313410 Using Near-Infrared Light to Better Understand Peripheral Artery Disease
| NCT ID | NCT07313410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Arlington |
| Condition | Peripheral Artery Disease (PAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-11-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Cases, Aim 1 1. 18 or older 2. willing to participate under the conditions described in the informed consent form (ICF) 3. eligible to sign the ICF 4. established diagnosis of PAD confirmed by a physician 5. able to comply with the study requirements * Cases, Aim 2 1\) completed Aim 1 * Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease Exclusion Criteria: * Cases, Aim 1 1. Ankle-Brachial Index \>0.9 or \<0.4 2. isolated disease in aorta/iliac vessels 3. unstable angina or myocardial infarction in past 12 months 4. orthopedic or other physical limitations which would prevent data collection 5. 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 1. unstable angina or myocardial infarction in past 12 months 2. orthopedic or other physical limitations which would prevent data collection 3. 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07313410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Artery Disease (PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313410 currently recruiting?
Yes, NCT07313410 is actively recruiting participants. Contact the research team at michael.nelson3@uta.edu for enrollment information.
Where is the NCT07313410 trial being conducted?
This trial is being conducted at Arlington, United States, Arlington, United States.
Who is sponsoring the NCT07313410 clinical trial?
NCT07313410 is sponsored by The University of Texas at Arlington. The trial plans to enroll 120 participants.