Pressure Ulcer (PU)Pressure UlcerNCT07307885
The Effect of Photobiomodulation on Pressure Ulcers
A study testing photobiomodulation in people with Pressure Ulcer (PU), run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer (PU)
- What is being tested?
- photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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)
- Being tested
- photobiomodulation
- Keywords
- photobiomodulation, Pressure Ulcer, wound care
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
The effectiveness of photobiomodulation application in chronic wound healing will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| photobiomodulation group | Experimental | photobiomodulation intervention group Receives: Device: photobiomodulation |
| control group | No intervention | routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 May 2026
- Primary completion20 Mar 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer (PU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Fenerbahce University, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Responsible party
- Principal investigator, Hülya Elmalı Şimşek, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307885
- Sponsor's protocol ID
- Ankaramedipol
- Other IDs
- university
- Acronym
- Pressure Ulcer
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07307885
- Acronym / sponsor ID
- Pressure Ulcer / Ankaramedipol
- Conditions
- Pressure Ulcer (PU)
- Keywords
- photobiomodulation, Pressure Ulcer, wound care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Fenerbahce University, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| photobiomodulation group | Experimental | Device: photobiomodulationphotobiomodulation intervention group |
| control group | No intervention | –routine hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photobiomodulationThe effectiveness of photobiomodulation application in chronic wound healing will be evaluated. | Device | photobiomodulation group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation in people with Pressure Ulcer (PU), run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.