The Effect of Photobiomodulation on Pressure Ulcers

NCT07307885 | Not Yet Recruiting

• 2 other identifiers: Ankaramedipoluniversity
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pressure Ulcer (PU)

Keywords

photobiomodulation; Pressure Ulcer; wound care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

photobiomodulation group

EXPERIMENTAL

photobiomodulation intervention group

Device: photobiomodulation

control group

NO INTERVENTION

routine hospital care

Interventions

photobiomodulation DEVICE

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

photobiomodulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: collaborator
• Ankara Medipol University: lead
• Dr. Lutfi Kirdar Kartal Training and Research Hospital: collaborator

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Hülya Elmalı Şimşek, PhD

CONTACT

+90 533 381 1732; hulya.elmali34@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03