- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370199
Peripheral Blood Flow Responses to Electromagnetic Energy
April 16, 2024 updated by: Nicole Lohr, University of Alabama at Birmingham
This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults.
All participants will receive red light to their leg.
They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
670 nm energy in the form of red light dilates isolated blood vessels.
This study seeks to measure vessel dilation in human subjects exposed to this energy at different irradiance intensities (25 milliwatts (mW)/cm2 and 75 mW/cm2).
The intent of this protocol is to measure blood flow in the gastrocnemius muscle before and after exposure to 670 nm light energy.
This protocol will be performed in healthy subjects, who do not meet exclusion criteria.
The study consists of one visit.
Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream.
Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image.
After baseline blood flow images are collected, the subject will receive red light energy to the gastrocnemius muscle with concurrent blood flow measurements with contrast ultrasound.
The subject will be monitored post procedure and the study will then be completed.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole L Lohr, MD, PhD
- Phone Number: 205-996-3504
- Email: nlohr@uabmc.edu
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Nicole L Lohr, MD PhD
- Phone Number: 205-996-3504
- Email: nlohr@uabmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants will be healthy subjects over the age of 18.
- Men and women will be recruited for participation.
- All ethnicities will be included in this study.
Exclusion Criteria:
Exclusionary criteria include:
- age under 18 years and those over 60 years of age,
- those who are unable to understand the consent process,
- those who cannot read or speak English,
- a history of cancer,
- peripheral artery disease,
- diabetes mellitus,
- active pregnancy,
- hypersensitivity to perflutren contrast agents,
- pulmonary hypertension,
- chronic kidney disease,
- active tobacco or drug use,
- blood pressure over 160/90, BMI>30,
- sickle cell disease, or
- history of intracardiac shunt.
Additional exclusion criteria include:
- a history of coronary artery disease,
- heart failure,
- the presence of an implanted defibrillator or pacemaker,
- a history of heart murmur or rhythm disorder (atrial fibrillation, atrial tachycardia, or ventricular tachycardia),
- neurological diseases such as stroke, and
- any uncontrolled medical conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 670 nm light
Subjects will have baseline blood flow measured in the gastrocnemius using octafluoropropane infusion and ultrasound.After baseline flow measurements are obtained, a 670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle.
The diode will not be in direct contact with the skin.
Subjects will be exposed to 75 mW/cm2.
Contrast images will be obtained up to 5 minutes after the commencement of light.
|
670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle.
The diode will not be in direct contact with the skin.
Subjects will be exposed to 75 mW/cm2.
Other Names:
Octofluoropropane will be administered as a continuous infusion prior to the initiation of 670 nm light in order to measure skeletal muscle blood flow.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood flow (using octafluoropropane infusion and ultrasound)
Time Frame: 10 minutes
|
Blood flow changes based on ultrasound imaging
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicole L Lohr, MD, PhD, Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
February 23, 2015
First Posted (Estimated)
February 24, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 22652
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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