MicrocirculationPBM&MBF01NCT07338695
The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature
A study testing Photobiomodulation - Blue Wavelength and Photobiomodulation - Near Infrared in people with Microcirculation, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation
- What is being tested?
- Photobiomodulation - Blue Wavelength and Photobiomodulation - Near Infrared
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Microcirculation
- Being tested
- Photobiomodulation - Blue Wavelength, Photobiomodulation - Near Infrared
- Keywords
- Photoniomodulation, low-level laser, microcirculatory blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation - Blue WavelengthDevice
Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.
Photobiomodulation - Near InfraredDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation - Blue Wavelength; Device: Photobiomodulation - Near Infrared |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 hour
Secondary outcomes (1)
Temperature distribution over hands measured by thermography
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.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of Engineering
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338695
- Sponsor's protocol ID
- 09-12-2024-AFK
- Other IDs
- PBM&MBF01
- Acronym
- PBM&MBF01
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32064652Ovadia-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.
PubMed 37817983
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Changes in Peripheral Microcirculation in Response to Photobiomodulation Using Non-Invasive Optical and Thermal Technologies
- ClinicalTrials.gov ID
- NCT07338695
- Acronym / sponsor ID
- PBM&MBF01 / 09-12-2024-AFK
- Conditions
- Microcirculation
- Keywords
- Photoniomodulation, low-level laser, microcirculatory blood flow
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of EngineeringUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blue → Near-Infrared PBM | Experimental | Device: Photobiomodulation - Blue Wavelength, Device: Photobiomodulation - Near InfraredParticipants receive photobiomodulation at a blue wavelength in the first session and at a near-infrared wavelength in the second session. |
| Near-Infrared → Blue PBM | Experimental | Device: Photobiomodulation - Blue Wavelength, Device: Photobiomodulation - Near InfraredParticipants receive photobiomodulation at a near-infrared wavelength in the first session and at a blue wavelength in the second session. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation - Blue WavelengthPhotobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design. | Device | Blue → Near-Infrared PBM, Near-Infrared → Blue PBM |
| Photobiomodulation - Near InfraredPhotobiomodulation delivered at a near-infrared wavelength (780-1100 nm) to the hands during a single study session as part of a randomized crossover design. | Device | Blue → Near-Infrared PBM, Near-Infrared → Blue PBM |
Primary outcome
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.
1 secondary outcome
Temperature distribution over hands measured by thermography
Time frame: Up to 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 32064652Gavish 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.
- Background: PubMed 37817983Ovadia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation - Blue Wavelength and Photobiomodulation - Near Infrared in people with Microcirculation, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood flow (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.