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Red Light Treatment in Peripheral Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203239
Recruitment Status : Suspended (COVID-19)
First Posted : June 29, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Lohr, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Claudication, Intermittent Vasodilation Device: Red Light (670 nm energy) Drug: Octafluoropropane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single group study in which the subject undergoes a single exposure to red light.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vasodilatory Effects of Light on Peripheral Artery Disease
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arm Intervention/treatment
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.
Device: 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.

Drug: Octafluoropropane
All subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.
Other Name: Definity




Primary Outcome Measures :
  1. Changes in blood flow [ Time Frame: Baseline, 5 min of light, and up to 1 min after discontinuation of light ]
    Video intensity units from contrast images will be converted to ml/min/g tissue


Secondary Outcome Measures :
  1. Changes in nitric oxide metabolites [ Time Frame: Baseline and 1 min after discontinuation of light ]
    NO measurement by ozone chemiluminescence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203239


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Nicole L Lohr, MD,PHD Medical College of Wisconsin
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Responsible Party: Nicole Lohr, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03203239    
Other Study ID Numbers: 29388
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicole Lohr, Medical College of Wisconsin:
red light
vasodilation
nitric oxide
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms