The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature

NCT07338695 | Enrolling By Invitation

• 2 other identifiers: 09-12-2024-AFKPBM&MBF01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microcirculation

Keywords

Photoniomodulation; low-level laser; microcirculatory blood flow

Outcome Measures

Primary Outcomes (1)

• Capillary blood flow

  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 Outcomes (1)

• Temperature distribution over hands measured by thermography

  Up to 1 hour

Other Outcomes (1)

• Photoplethysmography (PPG)-derived perfusion response

  Up to 1 hour

Study Arms (2)

Blue → Near-Infrared PBM

EXPERIMENTAL

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; Device: Photobiomodulation - Near Infrared

Near-Infrared → Blue PBM

EXPERIMENTAL

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; Device: Photobiomodulation - Near Infrared

Interventions

Photobiomodulation - Blue Wavelength DEVICE

Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.

Blue → Near-Infrared PBM; Near-Infrared → Blue PBM

Photobiomodulation - Near Infrared DEVICE

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.

Blue → Near-Infrared PBM; Near-Infrared → Blue PBM

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Afeka, The Tel-Aviv Academic College of Engineering: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Israel

Location

Related Publications (2)

• Gavish L, Hoffer O, Rabin N, Halak M, Shkilevich S, Shayovitz Y, Weizman G, Haim O, Gavish B, Gertz SD, Ovadia-Blechman Z. Microcirculatory Response to Photobiomodulation-Why Some Respond and Others Do Not: A Randomized Controlled Study. Lasers Surg Med. 2020 Nov;52(9):863-872. doi: 10.1002/lsm.23225. Epub 2020 Feb 17.

  PMID: 32064652 BACKGROUND

• Ovadia-Blechman Z, Hauptman Y, Rabin N, Wiezman G, Hoffer O, Gertz SD, Gavish B, Gavish L. Morphological features of the photoplethysmographic signal: a new approach to characterize the microcirculatory response to photobiomodulation. Front Physiol. 2023 Sep 25;14:1175470. doi: 10.3389/fphys.2023.1175470. eCollection 2023.

  PMID: 37817983 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a within-subject crossover study in which participants receive photobiomodulation at blue and near-infrared wavelengths in separate sessions, with the order of exposure assigned in a crossover manner. Participants may present with functional peripheral vasoconstriction or normal peripheral temperature at baseline; these baseline characteristics will be used for subgroup analyses and do not define separate study arms.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)