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
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Claudication, Intermittent Vasodilation||Device: Red Light (670 nm energy) Drug: Octafluoropropane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
All subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.
Other Name: Definity
- 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
- Changes in nitric oxide metabolites [ Time Frame: Baseline and 1 min after discontinuation of light ]NO measurement by ozone chemiluminescence
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
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Nicole L Lohr, MD,PHD||Medical College of Wisconsin|