Recruiting

BB-NIR-DCS

Sponsor:

The University of Texas at Arlington

Code:

NCT07313410

Conditions

Peripheral Artery Disease (PAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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)

Study ID

NCT07313410

Start date

Nov 1, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

Individuals without PAD

Cases with PAD

Individuals with PAD

Primary outcome measure

  • Perceived Quality of life [ Time Frame: Baseline and up to 26 weeks ]
  • Ankle- Brachial Index [ Time Frame: Baseline and upto 26 weeks ]
  • Walking ability [ Time Frame: Baseline and upto 26 weeks ]
  • Functional performance [ Time Frame: Baseline and upto 26 weeks ]
  • Steps taken [ Time Frame: Baseline and upto 26 weeks ]
  • Oxygen level of leg muscles [ Time Frame: Baseline and upto 26 weeks ]
  • Body composition [ Time Frame: Baseline and up to 26 weeks ]
  • Leg Exercise MRI [ Time Frame: Baseline and upto 26 weeks ]
  • Lower Leg Ischemia-Reperfusion [ Time Frame: Baseline and up to 26 weeks ]
  • Leg muscle size and quality [ Time Frame: Baseline and up to 26 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Texas at Arlington

Recruiting

Arlington, Texas, United States, 76010

Contacts

Rajvi Shah

2147557

More Information

Sponsor

The University of Texas at Arlington

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas at Arlington on 2026-01-02.