The Effect of Photobiomodulation on Pressure Ulcers (Pressure Ulcer)

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

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:

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, and vital signs will be measured. No intervention will be performed other than the routine wound care procedure carried out in the intensive care unit. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14, in the same manner as in the intervention group.

Study Overview

• Status: Not yet recruiting
• Conditions: Pressure Ulcer (PU)
• Intervention / Treatment: Device: photobiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hülya Elmalı Şimşek, PhD; Phone Number: +90 533 381 1732; Email: hulya.elmali34@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: photobiomodulation group; photobiomodulation intervention group	Device: photobiomodulation; The effectiveness of photobiomodulation application in chronic wound healing will be evaluated.
No Intervention: control group; routine hospital care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healing of pressure sores in the patients in the experimental group will be faster and more effective than in the control group.	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).	14 days

Collaborators and Investigators

• Sponsor: Ankara Medipol University
• Collaborators: Dr. Lutfi Kirdar Kartal Training and Research Hospital; Fenerbahce University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: photobiomodulation; Pressure Ulcer; wound care
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: Ankaramedipol; University (Other Identifier: Kahramanmaras Sutcu Imam University, SCIENTIFIC RESEARCH PROJECTS COORDINATION UNIT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No