Actively Recruiting
Near-Infrared Diffuse Correlation Spectroscopy to Better Understand Peripheral Artery Disease and Its Effects on Leg Blood Flow and Oxygen Use
Led by The University of Texas at Arlington · Updated on 2026-01-02
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying peripheral artery disease (PAD) to better understand how blood flows and how oxygen is used in the lower limbs of affected individuals. The study aims to differentiate patients with oxygen delivery problems from those with mitochondrial dysfunction using a special technique called BB-NIR-DCS, and to see if this method can predict how patients respond to vascular treatments. This research is observational and involves both people with and without PAD to compare findings. Participants without PAD will complete study procedures up to two times: once at the start and again after 1 to 2 months. Those diagnosed with PAD may undergo up to four visits including baseline, follow-ups at 1 to 2 weeks, 1 to 2 months, and 4 to 6 months. Each visit includes various assessments such as MRI scans to measure muscle oxygenation and blood flow, questionnaires about quality of life and walking ability, and physical performance tests like treadmill walking and a six-minute walk. All participants will provide informed consent before joining. During the study, researchers will collect health history, physical measurements, and activity data using wearable monitors and logs. The main outcomes measured include quality of life, ankle-brachial index, walking ability, steps taken, oxygen levels in leg muscles, body composition, and muscle size and quality. The study may ask participants to return for repeat procedures if needed to ensure good data quality. The total participation period can last up to about six months for those with PAD.
CONDITIONS
Brief Title
Using Near-Infrared Light to Better Understand Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Willing and eligible to provide informed consent
- Established diagnosis of peripheral artery disease confirmed by a physician (for cases)
- Able to comply with study requirements
- Completed Aim 1 procedures (for Aim 2 cases)
- No history or diagnosis of peripheral artery disease (for controls)
You will not qualify if you...
- Ankle-Brachial Index greater than 0.9 or less than 0.4 (for cases)
- Disease isolated to aorta or iliac vessels (for cases)
- Unstable angina or myocardial infarction within the past 12 months
- Orthopedic or physical limitations preventing data collection
- Contraindications to MRI such as pacemaker, bone growth stimulators, tissue expanders, cochlear implants, permanent jewelry
- Unable to walk 10 feet unaided
- Receiving continuous oxygen therapy
- Pregnancy
- History of overt cardiovascular disease (for controls)
- Known pulmonary disease excluding mild asthma (for controls)
- Current tobacco use (for controls)
- Blood pressure over 150/90 mmHg at screening (for controls)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day visit with possible additional day if repeat procedures are needed due to image quality or equipment performance
Participants undergo baseline assessments including questionnaires, Ankle-Brachial Index, functional performance tests, activity monitoring, and MRI scans of the lower limbs.
1 to 2 visits (in-person) depending on image quality and equipment performance
Duration - Up to 6 months depending on participant group
Participants without peripheral artery disease complete follow-up assessments at 1 to 2 months. Participants with peripheral artery disease may complete follow-up assessments up to 4 times over 4 to 6 months to monitor leg blood flow and oxygen use.
Up to 4 visits depending on participant group and follow-up schedule
Trial Site Locations
Total: 2 locations
1
University of Texas at Arlington
Arlington, Texas, United States, 76010
Actively Recruiting
2
University of Texas Arlington
Arlington, Texas, United States, 76019
Not Yet Recruiting
Research Team
M
Michael Nelson, PhD
R
Rajvi Shah, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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