Vascular DysfunctionLEDNCT07041697
LED Photobiomodulation Improves Radial Artery Vascular Function in Vitro
A study testing Light-emitting diode photobiomodulation therapy in people with Vascular Dysfunction, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
LED photobiomodulation therapy (PBMT) is widely recognized for its beneficial effects in several clinical conditions; however, its potential in modulating vascular function is not yet fully established. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Dysfunction
- What is being tested?
- Light-emitting diode photobiomodulation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jan 2023to 21 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing coronary artery bypass grafting using the radial artery
Who cannot join
- Patients with poorly compliant radial arteries or those who underwent coronary artery bypass grafting without use of the radial artery were excluded from the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Medical School in Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Application of Photobiomodulation Therapy by LED Using a Combined Red and Near-infrared Light Spectrum Improves the Vascular Function of the Radial Artery in Vitro
LED photobiomodulation therapy (PBMT) is widely recognized for its beneficial effects in several clinical conditions; however, its potential in modulating vascular function is not yet fully established. Objective: This study aimed to evaluate the application of PBMT by LED (light-emittion diode) using a combined red and near-infrared light spectrum, with a focus on improving the vascular function of the radial artery in vitro. Methodology: A total of 30 radial artery segments were studied and divided into three groups of 10 segments: the PBMT LED group combined with red and infrared light (R + IR), the red light (R) group, and the infrared light (IR) group. Prior to light irradiation at wavelengths of 650 nm and 940 nm, vascular function in these segments was pharmacologically inhibited using L-NAME. The drugs phenylephrine, acetylcholine, and sodium nitroprusside were used to determine if irradiation could restore the inhibited vascular functions. Superoxide anion levels, an important reactive oxygen specie (ROS), were measured using a chemiluminescence assay with lucigenin. The bioavailability of nitric oxide was evaluated using a Griess Reagent Kit assay, while nitric oxide production was assessed through the DAF fluorescence assay. The vascular inflammation was determined by the Intercellular Adhesion Molecule 1 (ICAM-1) expression.
- Conditions
- Vascular Dysfunction
- Being tested
- Light-emitting diode photobiomodulation therapy
- Keywords
- Photobiomodulation, Light-emitting diode, Vascular function, Radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-emitting diode photobiomodulation therapyDevice
For the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Using Red LED Light at 650 nm Wavelength | Experimental | The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. Receives: Device: Light-emitting diode photobiomodulation therapy |
| Photobiomodulation Using Red LED Light at 940 nm Wavelength | Experimental | The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. Receives: Device: Light-emitting diode photobiomodulation therapy |
| Photobiomodulation with Combined Red (650 nm) and Infrared (940 nm) LED Light | Experimental | The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. Receives: Device: Light-emitting diode photobiomodulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of Isolated Radial Artery Rings (2 mm)
Description of Primary Outcome Measure(s):
The primary outcome of this study is the evaluation of vascular compliance during vasodilation of isolated radial artery rings (2 mm in diameter), with a specific focus on the effects of LED photobiomodulation on arterial function.
Measured: 12 months
Secondary outcomes (1)
Evaluation of reactive oxygen species (ROS)
Superoxide anion (O₂--) generation, a key reactive oxygen species (ROS), will be measured in arterial tissue from the R + IR, R, and IR groups using a lucigenin-enhanced chemiluminescence assay. Lucigenin will serve as the electron acceptor, and nicotinamide adenine dinucleotide phosphate (NADPH) as the substrate. Results will be expressed as a percentage of concentration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start12 Jan 2023
- Primary completion21 Dec 2024
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DysfunctionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- To irradiate the arteries, we used a 14 cm × 14 cm LED blanket composed of 30 red-spectrum LEDs (wavelength: 650 nm), delivering a power density of 1.9 mW/cm² and an energy density of 1.7 J/cm² over an irradiation period of 83 seconds. A separate 14 cm × 14 cm infrared LED blanket, also containing 30 LEDs (wavelength: 940 nm), delivered a power density of 1.7 mW/cm² and an energy density of 1.7 J/cm² with an irradiation time of 94 seconds. Additionally, a 14 cm × 14 cm mixed LED blanket, consisting of 18 red (650 nm) and 18 infrared (940 nm) LEDs, provided a power density of 1.7 mW/cm² and an energy density of 0.16 J/cm² over an irradiation period of 73 seconds.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Timóteo Sapalo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041697
- Sponsor's protocol ID
- 4.829.712
- Acronym
- LED
- Status last verified
- Jun 2025
- First submitted
- 25 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Photobiomodulation Therapy by LED Using a Combined Red and Near-infrared Light Spectrum Improves the Vascular Function of the Radial Artery in Vitro
- ClinicalTrials.gov ID
- NCT07041697
- Acronym / sponsor ID
- LED / 4.829.712
- Conditions
- Vascular Dysfunction
- Keywords
- Photobiomodulation, Light-emitting diode, Vascular function, Radial artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 27 Jun 2025 (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.
LED photobiomodulation therapy (PBMT) is widely recognized for its beneficial effects in several clinical conditions; however, its potential in modulating vascular function is not yet fully established. Objective: This study aimed to evaluate the application of PBMT by LED (light-emittion diode) using a combined red and near-infrared light spectrum, with a focus on improving the vascular function of the radial artery in vitro. Methodology: A total of 30 radial artery segments were studied and divided into three groups of 10 segments: the PBMT LED group combined with red and infrared light (R + IR), the red light (R) group, and the infrared light (IR) group. Prior to light irradiation at wavelengths of 650 nm and 940 nm, vascular function in these segments was pharmacologically inhibited using L-NAME. The drugs phenylephrine, acetylcholine, and sodium nitroprusside were used to determine if irradiation could restore the inhibited vascular functions. Superoxide anion levels, an important reactive oxygen specie (ROS), were measured using a chemiluminescence assay with lucigenin. The bioavailability of nitric oxide was evaluated using a Griess Reagent Kit assay, while nitric oxide production was assessed through the DAF fluorescence assay. The vascular inflammation was determined by the Intercellular Adhesion Molecule 1 (ICAM-1) expression.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- To irradiate the arteries, we used a 14 cm × 14 cm LED blanket composed of 30 red-spectrum LEDs (wavelength: 650 nm), delivering a power density of 1.9 mW/cm² and an energy density of 1.7 J/cm² over an irradiation period of 83 seconds. A separate 14 cm × 14 cm infrared LED blanket, also containing 30 LEDs (wavelength: 940 nm), delivered a power density of 1.7 mW/cm² and an energy density of 1.7 J/cm² with an irradiation time of 94 seconds. Additionally, a 14 cm × 14 cm mixed LED blanket, consisting of 18 red (650 nm) and 18 infrared (940 nm) LEDs, provided a power density of 1.7 mW/cm² and an energy density of 0.16 J/cm² over an irradiation period of 73 seconds.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Using Red LED Light at 650 nm Wavelength | Experimental | Device: Light-emitting diode photobiomodulation therapyThe three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. |
| Photobiomodulation Using Red LED Light at 940 nm Wavelength | Experimental | Device: Light-emitting diode photobiomodulation therapyThe three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. |
| Photobiomodulation with Combined Red (650 nm) and Infrared (940 nm) LED Light | Experimental | Device: Light-emitting diode photobiomodulation therapyThe three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary artery bypass grafting using the radial artery
Key exclusion criteria (1 listed)
- Patients with poorly compliant radial arteries or those who underwent coronary artery bypass grafting without use of the radial artery were excluded from the study
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 |
|---|---|---|
| Light-emitting diode photobiomodulation therapyFor the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds. | Device | Photobiomodulation Using Red LED Light at 650 nm Wavelength, Photobiomodulation Using Red LED Light at 940 nm Wavelength, Photobiomodulation with Combined Red (650 nm) and Infrared (940 nm) LED Light |
Primary outcome
Diameter of Isolated Radial Artery Rings (2 mm)
Time frame: 12 months
Description of Primary Outcome Measure(s): The primary outcome of this study is the evaluation of vascular compliance during vasodilation of isolated radial artery rings (2 mm in diameter), with a specific focus on the effects of LED photobiomodulation on arterial function.
1 secondary outcome
Evaluation of reactive oxygen species (ROS)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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. This study is not recruiting at the moment.
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 Light-emitting diode photobiomodulation therapy in people with Vascular Dysfunction, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jun 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diameter of Isolated Radial Artery Rings (2 mm) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.