Red Light Treatment in Peripheral Artery Disease

NCT03203239 | Recruiting

• 1 other identifier: 29388
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

red light; vasodilation; nitric oxide

Outcome Measures

Primary Outcomes (1)

• Changes in blood flow

  Video intensity units from contrast images will be converted to ml/min/g tissue

  Baseline, 5 min of light, and up to 1 min after discontinuation of light

Secondary Outcomes (1)

• Changes in nitric oxide metabolites

  Baseline and 1 min after discontinuation of light

Study Arms (1)

Red Light treatment

EXPERIMENTAL

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

Device: Red Light (670 nm energy); Drug: Octafluoropropane

Interventions

Red Light (670 nm energy) DEVICE

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.

Red Light treatment

Octafluoropropane DRUG

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

Also known as: Definity

Red Light treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Aneurysm

Interventions

perflutren

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole L Lohr, MD,PHD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole L Lohr, MD,PHD

CONTACT

414-996-3504; nlohr@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single group study in which the subject undergoes a single exposure to red light.

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: January 17, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)