Recruiting

Red Light Treatment

Sponsor:

University of Alabama at Birmingham

Code:

NCT03203239

Conditions

Peripheral Artery Disease

Claudication, Intermittent

Vasodilation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Red Light (670 nm energy)

Octafluoropropane

Study Details

Brief summary:

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

Conditions

Peripheral Artery Disease

Claudication, Intermittent

Vasodilation

Study ID

NCT03203239

Start date

Jan 17, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants will be subjects between the ages of 18 and 85 who have been diagnosed with peripheral artery disease. Men and women will be recruited for participation. All ethnicities will be included in this study.

Diagnosis of peripheral artery disease is defined as an Ankle Brachial index of <0.9 or greater than 1.1 either at rest or during treadmill exercise.

Exclusion Criteria:

  • Exclusionary criteria include age under 18 years and over 85 years, those who are unable to understand the consent process , those who cannot read or speak English, active pregnancy, hypersensitivity to perflutren contrast agents, pulmonary hypertension, active illicit drug use, untreated blood pressure over 160/95, sickle cell disease, or a history of intracardiac shunt. Additional exclusion criteria neurological diseases such as spinal stenosis, unspecified pain disorders, and any uncontrolled medical conditions.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Red Light treatment

This is a single arm design. All subjects will be enrolled to have peripheral blood flow measured before, during, and after red light exposure.

Interventions

Red Light (670 nm energy)

Light Emitting Diode light source (670 nm wavelength with output up to 75mW/cm2) will be placed over the gastrocnemius muscle. The light will be on for 5 minutes.

Octafluoropropane

All subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.

Primary outcome measure

  • Changes in blood flow [ Time Frame: Baseline, 5 min of light, and up to 1 min after discontinuation of light ]

Central Contacts and Locations

Central contacts

Nicole L Lohr, MD,PHD

414-996-3504nlohr@uabmc.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Nicole L Lohr, MD PhD

205-996-3504nlohr@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • red light
  • vasodilation
  • nitric oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-01.