The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature (PBM&MBF01)

January 4, 2026 updated by: Afeka, The Tel-Aviv Academic College of Engineering

Evaluation of Hemodynamic Changes in Peripheral Microcirculation in Response to Photobiomodulation Using Non-Invasive Optical and Thermal Technologies

The objective of this study is to assess peripheral microcirculatory hemodynamic responses to photobiomodulation in participants with normal circulation and with functional peripheral vasoconstriction, using noninvasive thermography, photoplethysmography, and laser Doppler flowmetry.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a within-subject experimental study in which each participant completes two study sessions. Microvascular and systemic variables are continuously monitored in response to photobiomodulation delivered at either a blue or near-infrared wavelength, with each wavelength applied in a separate session.

Each session includes a baseline period with controlled breathing, followed by photobiomodulation and a 20-minute post-intervention follow-up period. Peripheral microcirculatory responses are assessed using noninvasive thermography, photoplethysmography, and laser Doppler flowmetry.

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 Locations

  • Israel
      • Tel Aviv, Israel
        • Afeka, Tel-Aviv Academic College of Engineering

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy males and females, between 20 and 75 years of age.
  2. Willing to sign informed consent.
  3. Willing to participate in two separate sessions, one for each wavelength.
  4. Able to avoid caffeine and alcohol for at least 3 hours before each session.
  5. Able to sit comfortably with both hands at heart level for the full measurement duration.

Exclusion Criteria:

  1. Currently smoking
  2. Any abnormal skin condition in the area of light irradiation.
  3. Pregnant, having given birth less than 3 months ago, and/or breastfeeding.
  4. History of photosensitive conditions or use of photosensitizing medications
  5. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
  6. As per the Investigator's discretion, any physical or mental condition that might make it unsafe for the subject to participate in this study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blue → Near-Infrared PBM
Participants receive photobiomodulation at a blue wavelength in the first session and at a near-infrared wavelength in the second session.
Device: Photobiomodulation - Blue Wavelength
Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.
Device: Photobiomodulation - Near Infrared
Photobiomodulation delivered at a near-infrared wavelength (780-1100 nm) to the hands during a single study session as part of a randomized crossover design.
Experimental: Near-Infrared → Blue PBM
Participants receive photobiomodulation at a near-infrared wavelength in the first session and at a blue wavelength in the second session.
Device: Photobiomodulation - Blue Wavelength
Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.
Device: Photobiomodulation - Near Infrared
Photobiomodulation delivered at a near-infrared wavelength (780-1100 nm) to the hands during a single study session as part of a randomized crossover design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capillary blood flow
Time Frame: Up to 1 hour
Capillary blood flow, expressed as red blood cell flux (perfusion units), measured continuously using laser Doppler flowmetry (≥10 Hz sampling rate) from baseline through the end of each study session.
Up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature distribution over hands measured by thermography
Time Frame: Up to 1 hour
Thermal images will be acquired using a FLIR infrared camera, and spatial temperature distribution over the hands will be analyzed. Images will be acquired at one-minute intervals from baseline through the end of each study session.
Up to 1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photoplethysmography (PPG)-derived perfusion response
Time Frame: Up to 1 hour
Continuous photoplethysmography (PPG) will be recorded from the hand, and PPG-derived perfusion metrics (e.g., pulse amplitude and related indices) will be quantified to assess changes in peripheral microcirculation following photobiomodulation.
Up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afeka, The Tel-Aviv Academic College of Engineering

Collaborators

Hebrew University of Jerusalem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-12-2024-AFK
  • PBM&MBF01 (Other Identifier: Afeka)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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