Pressure InjuryNCT07853534
Machine Learning-Based Pressure Injury Staging and Nursing Care in Intensive Care
A study testing Mobile Application for Pressure Injury Staging and Nursing Care Guidance and Standard Clinical Care in people with Pressure Injury, run by Ertugrul Sari at 1 site in Turkey (Türkiye).
Trial summary
This study aims to develop a mobile nursing care system that uses machine learning to support pressure injury staging and to evaluate its effect on pressure injury healing in an intensive care unit. The system will provide stage-based care guidance and support wound monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Mobile Application for Pressure Injury Staging and Nursing Care Guidance and Standard Clinical Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years.
- Diagnosed with a pressure injury.
- Hemodynamically stable, as assessed by the treating clinician.
- Remained in the intensive care unit for at least 48 hours after identification of the pressure injury.
- The patient or their legal representative provides verbal and written informed consent after receiving information about the study.
Who cannot join
- Intensive care unit stay of less than 48 hours after identification of the pressure injury.
- The wound cannot be photographed because of extensive infection or necrotic tissue in the wound area.
- The patient or their legal representative does not consent to participation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Health Application and Research Center Farabi Hospital (Intensive Care Unit 3)
Trabzon, Trabzon, 61000
About this study
Official title: Development of a Nursing Care System Based on Pressure Injurement Staging Using Machine Learning and Its Implementation in the Intensive Care Unit
This study aims to develop a mobile nursing care system that uses machine learning to support pressure injury staging and to evaluate its effect on pressure injury healing in an intensive care unit. The system will provide stage-based care guidance and support wound monitoring.
The clinical evaluation will use a quasi-experimental, pretest-posttest design with a control group. A total of 70 patients with pressure injuries are planned to be included: 35 in the intervention group and 35 in the control group. Data will be collected using a patient information and monitoring form, the Braden Scale, and the Bates-Jensen Wound Assessment Tool. Changes in wound condition and healing will be compared between the groups.
Read the detailed description
This study consists of two stages:
First, a machine learning-based system will be developed to classify pressure ulcers based on clinical images, measure wound surface area, and provide stage-specific, evidence-based nursing care guidelines.
Secondly, the system will be evaluated in an intensive care unit through a quasi-experimental study. During the control phase, pressure injury assessment and nursing care will be carried out in accordance with current practices. Subsequently, nurses will receive training on the use of the mobile system. In the intervention phase, nurses will use the system to support the developed processes for pressure injury staging, care planning, and wound monitoring.
Patient characteristics, wound characteristics, and the healing process will be recorded using study forms and assessment tools. Changes in wound status will be evaluated throughout the observation period and compared between the control and intervention groups. The study will demonstrate the effect of the developed system on the healing of pressure injuries.
- Conditions
- Pressure Injury
- Being tested
- Mobile Application for Pressure Injury Staging and Nursing Care Guidance, Standard Clinical Care
- Keywords
- Artificial intelligence, evidence-based, intensive care, machine learning
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application for Pressure Injury Staging and Nursing Care GuidanceDevice
Specially trained intensive care nurses will use a mobile application during the assessment and care of patients with pressure injuries. The application employs a machine learning model to suggest the stage of the pressure injury based on an image of the wound and provides evidence-based, stage-specific nursing care guidance. It also enables objective measurement of the wound surface area. The application is intended for use alongside standard clinical care, and clinical decision-making will remain the responsibility of the healthcare team.
Standard Clinical CareOther
Patients in this arm will receive standard pressure injury care provided in the intensive care unit according to existing clinical practice. Nurses will assess and document the wounds without using the study's mobile application. Pressure injury outcomes will be measured using the same study assessment procedures as in the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinical Care | Active comparator | Patients in this arm will receive standard pressure injury care provided in the intensive care unit according to existing clinical practice. Nurses will assess and document the wounds without using the study's mobile application. Pressure injury outcomes will be measured using the same study assessment procedures as in the intervention arm. Receives: Other: Standard Clinical Care |
| Mobile Application-Supported Nursing Care | Experimental | Patients in this group will receive standard intensive care unit treatment and pressure ulcer care supported by the study's mobile application. Trained nurses will use this application to record assessments regarding pressure ulcer staging, evidence-based and stage-specific nursing care guidelines, and objective wound surface area measurements. Pressure ulcer outcomes will be measured using the same study assessment procedures as those used for the control group. Receives: Device: Mobile Application for Pressure Injury Staging and Nursing Care Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bates-Jensen Wound Assessment Tool Score
Pressure injury status will be assessed using the Bates-Jensen Wound Assessment Tool. Scores range from 13 to 65, with lower scores indicating better wound status. Change from Day 1 to Day 13 and scores at each assessment will be compared between groups.
Measured: Days 1, 3, 5, 7, 9, 11, and 13
Change in Pressure Injury Surface Area
Pressure injury surface area will be recorded in cm² on Days 1, 3, 5, 7, 9, 11, and 13. In the intervention group, the mobile application will calculate the wound area. Changes from Day 1 to Day 13 and trends over time will be compared between groups. A decrease in surface area will indicate wound healing.
Measured: Days 1, 3, 5, 7, 9, 11, and 13
Secondary outcomes (1)
Change in Braden Scale Score
Risk of pressure injury will be assessed using the Braden Scale at each assessment. Scores range from 6 to 23, with lower scores indicating greater risk. Change from Day 1 to Day 13 and scores over time will be compared between groups.
Measured: Days 1, 3, 5, 7, 9, 11, and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients with pressure injuries will be compared. The control group will receive standard clinical care. The intervention group will receive care supported by a mobile application that provides pressure injury staging and evidence-based, stage-specific nursing care guidance. Control group data will be collected before implementation of the mobile application, followed by intervention group data collection.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ertugrul Sari
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Ertugrul Sari, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853534
- Sponsor's protocol ID
- E-13562490-050.01.04-635562
- Other IDs
- 126S980
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including wound assessment scores, wound surface area measurements, and relevant clinical variables, will be available to qualified researchers upon reasonable request. A data dictionary may also be provided. Cropped pressure injury images without faces or direct identifiers may be shared when permitted by participant consent and ethics approval. Data and image requests will be reviewed for scientific purpose and data security before access is granted.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Nursing Care System Based on Pressure Injurement Staging Using Machine Learning and Its Implementation in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07853534
- Acronym / sponsor ID
- E-13562490-050.01.04-635562
- Conditions
- Pressure Injury
- Keywords
- Artificial intelligence, evidence-based, intensive care, machine learning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ertugrul SariUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 1 Oct 2026 (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.
This study aims to develop a mobile nursing care system that uses machine learning to support pressure injury staging and to evaluate its effect on pressure injury healing in an intensive care unit. The system will provide stage-based care guidance and support wound monitoring.
The clinical evaluation will use a quasi-experimental, pretest-posttest design with a control group. A total of 70 patients with pressure injuries are planned to be included: 35 in the intervention group and 35 in the control group. Data will be collected using a patient information and monitoring form, the Braden Scale, and the Bates-Jensen Wound Assessment Tool. Changes in wound condition and healing will be compared between the groups.
Detailed description
This study consists of two stages:
First, a machine learning-based system will be developed to classify pressure ulcers based on clinical images, measure wound surface area, and provide stage-specific, evidence-based nursing care guidelines.
Secondly, the system will be evaluated in an intensive care unit through a quasi-experimental study. During the control phase, pressure injury assessment and nursing care will be carried out in accordance with current practices. Subsequently, nurses will receive training on the use of the mobile system. In the intervention phase, nurses will use the system to support the developed processes for pressure injury staging, care planning, and wound monitoring.
Patient characteristics, wound characteristics, and the healing process will be recorded using study forms and assessment tools. Changes in wound status will be evaluated throughout the observation period and compared between the control and intervention groups. The study will demonstrate the effect of the developed system on the healing of pressure injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients with pressure injuries will be compared. The control group will receive standard clinical care. The intervention group will receive care supported by a mobile application that provides pressure injury staging and evidence-based, stage-specific nursing care guidance. Control group data will be collected before implementation of the mobile application, followed by intervention group data collection.
| Arm | Type | Receives |
|---|---|---|
| Standard Clinical Care | Active comparator | Other: Standard Clinical CarePatients in this arm will receive standard pressure injury care provided in the intensive care unit according to existing clinical practice. Nurses will assess and document the wounds without using the study's mobile application. Pressure injury outcomes will be measured using the same study assessment procedures as in the intervention arm. |
| Mobile Application-Supported Nursing Care | Experimental | Device: Mobile Application for Pressure Injury Staging and Nursing Care GuidancePatients in this group will receive standard intensive care unit treatment and pressure ulcer care supported by the study's mobile application. Trained nurses will use this application to record assessments regarding pressure ulcer staging, evidence-based and stage-specific nursing care guidelines, and objective wound surface area measurements. Pressure ulcer outcomes will be measured using the same study assessment procedures as those used for the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 65 years.
- Diagnosed with a pressure injury.
- Hemodynamically stable, as assessed by the treating clinician.
- Remained in the intensive care unit for at least 48 hours after identification of the pressure injury.
- The patient or their legal representative provides verbal and written informed consent after receiving information about the study.
Key exclusion criteria (3 listed)
- Intensive care unit stay of less than 48 hours after identification of the pressure injury.
- The wound cannot be photographed because of extensive infection or necrotic tissue in the wound area.
- The patient or their legal representative does not consent to participation.
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 |
|---|---|---|
| Mobile Application for Pressure Injury Staging and Nursing Care GuidanceSpecially trained intensive care nurses will use a mobile application during the assessment and care of patients with pressure injuries. The application employs a machine learning model to suggest the stage of the pressure injury based on an image of the wound and provides evidence-based, stage-specific nursing care guidance. It also enables objective measurement of the wound surface area. The application is intended for use alongside standard clinical care, and clinical decision-making will remain the responsibility of the healthcare team. | Device | Mobile Application-Supported Nursing Care |
| Standard Clinical CarePatients in this arm will receive standard pressure injury care provided in the intensive care unit according to existing clinical practice. Nurses will assess and document the wounds without using the study's mobile application. Pressure injury outcomes will be measured using the same study assessment procedures as in the intervention arm. | Other | Standard Clinical Care |
Primary outcome
Change in Bates-Jensen Wound Assessment Tool Score
Time frame: Days 1, 3, 5, 7, 9, 11, and 13
Pressure injury status will be assessed using the Bates-Jensen Wound Assessment Tool. Scores range from 13 to 65, with lower scores indicating better wound status. Change from Day 1 to Day 13 and scores at each assessment will be compared between groups.
Change in Pressure Injury Surface Area
Time frame: Days 1, 3, 5, 7, 9, 11, and 13
Pressure injury surface area will be recorded in cm² on Days 1, 3, 5, 7, 9, 11, and 13. In the intervention group, the mobile application will calculate the wound area. Changes from Day 1 to Day 13 and trends over time will be compared between groups. A decrease in surface area will indicate wound healing.
1 secondary outcome
Change in Braden Scale Score
Time frame: Days 1, 3, 5, 7, 9, 11, and 13
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 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including wound assessment scores, wound surface area measurements, and relevant clinical variables, will be available to qualified researchers upon reasonable request. A data dictionary may also be provided. Cropped pressure injury images without faces or direct identifiers may be shared when permitted by participant consent and ethics approval. Data and image requests will be reviewed for scientific purpose and data security before access is granted.
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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. This study is not recruiting at the moment.
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 Mobile Application for Pressure Injury Staging and Nursing Care Guidance and Standard Clinical Care in people with Pressure Injury, run by Ertugrul Sari 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 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?
Change in Bates-Jensen Wound Assessment Tool Score (time frame: Days 1, 3, 5, 7, 9, 11, and 13). The study lists 2 primary outcomes in all. 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 1 Oct 2026.