ClinicalTrials.gg
Enrolling by invitationNCT07307885Pressure UlcerUpdated Sep 21, 2026

The Effect of Photobiomodulation on Pressure Ulcers

An interventional study of photobiomodulation in Pressure Ulcer (PU), sponsored by Ankara Medipol University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Ankara Medipol University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pressure Ulcer (PU)

Browse trials for

Keywords

  • photobiomodulation
  • Pressure Ulcer
  • wound care
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 46 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Ankara Medipol University is the lead sponsor of 56 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Stage II pressure ulcers
  • Patients without any skin disease
  • Patients with albumin, , and blood glucose levels within normal ranges
  • Patients who will stay in the intensive care unit for 14 days or longer
  • Patients with a of 35 or below
  • Patients with vital signs within normal limits
  • Patients with an oxygen saturation level of 90% or above

Exclusion criteria

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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    photobiomodulation group

    photobiomodulation intervention group

    Device: photobiomodulation

  • No intervention
    control group

    routine hospital care

Interventions

  • Devicephotobiomodulation

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

06

What researchers measure

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).

    Time frame: 14 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.

Of 179 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 10 months is close to that.

Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2025
First posted
Dec 29, 2025
StartActual
May 1, 2026
Primary completionEst.
Mar 20, 2027
CompletionEst.
May 20, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07307885
Lead sponsor
Ankara Medipol University
Collaborators
Fenerbahce University, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Hülya Elmalı Şimşek (Asst Prof, Ankara Medipol University) — Principal investigator
First posted
Dec 29, 2025
Start date
May 1, 2026
Primary completion
Mar 20, 2027 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Sep 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion