Near-infrared light to map blood flow and muscle oxygen use in peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Health for Hungary: Long-term blood and health data collection to study aging and disease onset

  This study tests whether routine blood tests plus advanced molecular analyses can help detect the early stages of non-communicable diseases in adults over 40.

  Recruiting at 21 sites Center for Molecular Fingerprinting Research Nonprofit LLC · Balatonfüred and 32 other locations · NCT07743021

• Reducing blood clots after leg artery procedures with Factor XI inhibitors in adults with PAD

  This trial tests two drugs, REGN7508 and REGN9933, to see if they lower the chance of dangerous blood clots after leg artery restoration procedures in adults with peripheral artery disease.

  Recruiting at 32 sites Phase 3 Regeneron Pharmaceuticals · Alexander City, Alabama and 31 other locations · NCT07318610

• Detecting lower‑leg peripheral artery disease using segmental pulse arrival time

  This trial will test whether measuring segmental pulse arrival time, and whether warming the skin or elevating the foot, can help detect lower‑leg peripheral artery disease in adults aged 19 and older.

  Recruiting University of Nebraska · Omaha, Nebraska · NCT07226193

• Algae supplements for heart risk markers and gut health

  This trial will test whether daily supplements of spirulina or Gelidium corneum change gut microbes and improve heart‑disease risk markers in adults over 50 with cardiovascular disease, diabetes, or related conditions.

  Recruiting Universidade do Porto · Porto · NCT07173062

• Six-minute stepper test for people with peripheral artery disease

  This project will test whether the six-minute stepper test can measure exercise ability in adults with peripheral artery disease.

  Recruiting Gazi University · Ankara, Çankaya · NCT07169045

• Using shockwave balloons to treat severe calcification in leg arteries

  This study is testing whether shockwave balloon therapy can help people with peripheral artery disease who have severe calcification in their leg arteries feel better and improve blood flow.

  Recruiting Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT06713850

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.