Recruiting

Electromagnetic Energy

Sponsor:

University of Alabama at Birmingham

Code:

NCT02370199

Conditions

Exposure to Man-made Visible Light

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

670 nm light

octafluropropane

Study Details

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.

Conditions

Exposure to Man-made Visible Light

Study ID

NCT02370199

Start date

Nov, 2014

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

670 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.

octafluropropane

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

Primary outcome measure

  • Change in blood flow (using octafluoropropane infusion and ultrasound) [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Nicole L Lohr, MD, PhD

205-996-3504nlohr@uabmc.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Nicole L Lohr, MD PhD

205-996-3504nlohr@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-01.