The Effect of Photobiomodulation on Pressure Ulcers

Photobiomodulation Group (Intervention Group):

Before the intervention, the patient's skin sensitivity to light will be tested by applying light for 3 minutes to one-fourth of the forearm skin. If redness occurs and persists for more than 2 hours, this indicates photosensitivity, and the intervention will not be performed.

The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, vital signs will be measured, and then the intervention will begin. After routine wound care/cleaning procedures in the intensive care unit, without applying any medication, cream, or lotion to the wound area, red light (660 nm wavelength) will be applied to the wound area for 5 minutes at a distance of 55 cm during the first 3 days, and for 10 minutes at the same distance on the following days. This application will continue once daily for 14 days. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14 (Baracho et al., 2021; Viecelli et al., 2024; Lima et al., 2020).

Control Group:

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Key information

Conditions

Pressure Ulcer (PU) Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with Stage II pressure ulcers
Patients without any skin disease
Patients with albumin, platelet, and blood glucose levels within normal ranges
Patients who will stay in the intensive care unit for 14 days or longer
Patients with a BMI of 35 or below
Patients with vital signs within normal limits
Patients with an oxygen saturation level of 90% or above

Exclusion criteria

Patients who do not consent to participate in the study
Patients with severe nutritional problems and those who are cachectic
Patients with severe edema (+4 or above)
Patients with diabetes mellitus
Patients who show photosensitivity in the light sensitivity test
Patients with metastatic tumors, high fever, thromboangiitis obliterans, vascular insufficiency, active tuberculosis, acute soft tissue infection, pregnancy, bleeding tendency, skin sensory disorders, or skin allergies
Patients with acute injuries within the past 72 hours
Patients with a pacemaker, defibrillator, or other electronic implants
Patients taking medications known to cause photosensitivity

Treatment and study plan

Photobiomodulation

Device

The effectiveness of photobiomodulation application in chronic wound healing will be evaluated.

Primary outcomes

The healing of pressure sores in the patients in the experimental group will be faster and more effective than in the control group.

Time frame: 14 days

This application will be continued once a day for 14 days and wound evaluation will be made and wound photographs will be taken on days 1, 4, 7 and 14. Wound assessment will be based on Pressure Ulcer Scale for Healing-PUSH and wound measurement(diameter).

Study contacts

Contact information is provided by the study sponsor or research team.

Hülya Elmalı Şimşek, PhD

CONTACT

[email protected]

+90 533 381 1732

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Collaborators

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Fenerbahce University

Registry information

Official study title

The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial

Acronym: Pressure Ulcer

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 29, 2025
Registry last updated: Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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