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NCT Number: NCT02370199

Peripheral Blood Flow Responses to Electromagnetic Energy

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.

Recruiting

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Nicole L Lohr, MD PhD

CONTACT

[email protected]

205-996-3504

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

670 nm light

Device

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: Red light

octafluropropane

Drug

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: Definity

Primary outcomes

  1. Change in blood flow (using octafluoropropane infusion and ultrasound)

    Time frame: 10 minutes

    Blood flow changes based on ultrasound imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole L Lohr, MD, PhD

CONTACT

[email protected]

205-996-3504

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2015
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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