Near-infrared light to map blood flow and muscle oxygen use in peripheral artery disease
Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease
This project tries to use near-infrared light to measure blood flow and muscle oxygen use in people with peripheral artery disease and see if those measurements predict who will improve after vascular treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas at Arlington Academic / other |
| Locations | 2 sites (Arlington, Texas and 1 other locations) |
| Trial ID | NCT07313410 on ClinicalTrials.gov |
What this trial studies
This observational protocol uses broadband near-infrared diffuse correlation spectroscopy (BB-NIR-DCS) together with lower-limb MRI, functional walking tests, ankle-brachial index, questionnaires, and wearable activity monitors to characterize muscle perfusion and oxygen use in people with peripheral artery disease (PAD). People with PAD may be seen up to four times (baseline, 1-2 weeks, 1-2 months, and 4-6 months) while controls undergo up to two visits (baseline and 1-2 months). Imaging will include muscle perfusion and oxygenation measures at rest and during physiologic provocation (ischemia-reperfusion and exercise), and investigators may repeat scans if image quality requires it. The study aims to separate patients whose walking limits are driven mainly by poor oxygen delivery from those with mitochondrial dysfunction and to test whether BB-NIR-DCS measurements can predict individual responses to vascular intervention.
Who should consider this trial
Good fit: Adults (18+) with a physician-confirmed diagnosis of peripheral artery disease and ABI between 0.4 and 0.9 who can safely undergo MRI and perform treadmill or walking tests are ideal candidates.
Not a fit: People with ABI >0.9 or <0.4, isolated aorto-iliac disease, recent unstable angina or myocardial infarction, major mobility limits, MRI contraindications (e.g., pacemaker, certain implants), continuous oxygen therapy, or pregnancy would be excluded and are unlikely to benefit from the protocol.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify whether a patient’s walking limitations are due to poor blood delivery versus muscle metabolic problems and better predict who will benefit from vascular procedures.
How similar studies have performed: Prior work using MRI and near-infrared techniques has shown promise in measuring perfusion and oxygenation, but applying BB-NIR-DCS specifically to classify oxygen delivery versus mitochondrial dysfunction and predict individual intervention response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Arlington, Texas and 1 other locations
- University of Texas at Arlington — Arlington, Texas, United States (Recruiting)
- University of Texas Arlington — Arlington, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Michael Nelson, PhD
- Email: michael.nelson3@uta.edu
- Phone: 8175130383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.