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Peripheral Blood Flow Responses to Electromagnetic Energy

Peripheral Blood Flow Responses to Electromagnetic Energy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370199
Enrollment
40
Registered
2015-02-24
Start date
2014-11-01
Completion date
2027-12-31
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure to Man-made Visible Light

Brief summary

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.

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.

Interventions

DEVICE670 nm 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.

DRUGoctafluropropane

Octofluoropropane will be administered as a continuous infusion prior to the initiation of 670 nm light in order to measure skeletal muscle blood flow.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood flow (using octafluoropropane infusion and ultrasound)10 minutesBlood flow changes based on ultrasound imaging

Countries

United States

Contacts

CONTACTNicole L Lohr, MD, PhD
nlohr@uabmc.edu205-996-3504
PRINCIPAL_INVESTIGATORNicole L Lohr, MD, PhD

Medical College of Wisconsin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026