The Effect of Photobiomodulation on Pressure Ulcers

NCT ID: NCT07307885

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Ulcer (PU)

Keywords

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photobiomodulation Pressure Ulcer wound care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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photobiomodulation group

photobiomodulation intervention group

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type DEVICE

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

control group

routine hospital care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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photobiomodulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fenerbahce University

OTHER

Sponsor Role collaborator

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Hülya Elmalı Şimşek

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hülya Elmalı Şimşek, PhD

Role: CONTACT

Phone: +90 533 381 1732

Email: [email protected]

Other Identifiers

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university

Identifier Type: REGISTRY

Identifier Source: secondary_id

Ankaramedipol

Identifier Type: -

Identifier Source: org_study_id