The Effect of Photobiomodulation on Pressure Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: photobiomodulation.
- Who it may be relevant to
- Registry conditions: Pressure Ulcer (PU). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial
Overview
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.
Interventions
- Device photobiomodulation
The effectiveness of photobiomodulation application in chronic wound healing will be evaluated.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07307885 · Ankaramedipol · university