NCT07041697

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

April 25, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

PhotobiomodulationLight-emitting diodeVascular functionRadial artery

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Evaluation of reactive oxygen species (ROS)

    12 months

Study Arms (3)

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.

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.

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.

Device: Light-emitting diode photobiomodulation therapy

Interventions

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.

Photobiomodulation Using Red LED Light at 650 nm WavelengthPhotobiomodulation Using Red LED Light at 940 nm WavelengthPhotobiomodulation with Combined Red (650 nm) and Infrared (940 nm) LED Light

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing coronary artery bypass grafting using the radial artery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo Medical School in Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 25, 2025

First Posted

June 27, 2025

Study Start

January 12, 2023

Primary Completion

December 21, 2024

Study Completion

February 21, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations