Pressure InjuryNCT07891689
Explainable AI for Prospective Pressure Injury Staging
An observational study of Pressure Injury, run by hatice akaltun at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational mixed-methods study aims to develop and evaluate an explainable artificial intelligence model for staging pressure injuries using standardized clinical photographs and expert panel-labeled images from adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- How many people
- 415 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to Oct 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults aged 18 years or older with at least one pressure injury who are receiving care in the participating clinical units. Standardized clinical photographs and clinical data will be collected prospectively. In addition, approximately 10-15 nurses working in intensive care or surgical units and involved in pressure injury care will be invited to participate in individual semi-structured interviews. Patients and nurses will participate voluntarily after providing informed consent.
Who may be able to join
- Adults aged 18 years or older.
- Patients with at least one pressure injury.
- Patients whose pressure injury can be photographed according to the study protocol.
- Patients or legally authorized representatives who provide informed consent.
- For the qualitative component:
- Nurses working in intensive care or surgical units.
- Nurses involved in pressure injury care.
- Nurses who provide informed consent and agree to participate in an individual semi-structured interview.
Who cannot join
- Patients who do not provide informed consent.
- Patients whose clinical condition does not allow the photography procedure.
- Images that are technically inadequate or do not meet the study quality criteria.
- Nurses who do not provide informed consent.
- Nurses who are unable to complete the interview.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sbu. Van Education and Research Hospital
Van, 65000
Hatice Akaltun, lecturer dr, 0 (432) 444 50 65 ext. 21242, haticeakaltun@yyu.edu.tr
About this study
Official title: Staging of Pressure Injuries Using Explainable Artificial Intelligence: A Prospective Clinical Decision Support Study With Expert Panel-Labeled Images
This prospective observational mixed-methods study aims to develop and evaluate an explainable artificial intelligence model for staging pressure injuries using standardized clinical photographs and expert panel-labeled images from adult patients. The study will also explore nurses' views on the clinical acceptability and usability of the decision-support system through semi-structured interviews.
- Conditions
- Pressure Injury
- Keywords
- Pressure injury staging, Explainable artificial intelligence, Machine learning, Clinical decision support, nurses
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients with Pressure Injuries | Adult patients with pressure injuries whose standardized clinical photographs and clinical data will be collected prospectively. Pressure injuries will be independently staged by an expert panel, and the images will be used to develop and evaluate an explainable artificial intelligence model. No intervention will be administered. | |
| Nurses Participating in Interviews | Approximately 10-15 nurses working in intensive care and surgical units who provide pressure injury care will participate in individual semi-structured interviews. The interviews will explore their views on the clinical acceptability, usability, interpretability, and potential use of the explainable artificial intelligence decision-support system. No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Explainable Artificial Intelligence Model in Pressure Injury Staging
The proportion of pressure injury images correctly staged by the explainable artificial intelligence model compared with the reference staging determined by the expert panel. Accuracy will be calculated as the number of correctly classified images divided by the total number of evaluable images.
Measured: From completion of image collection through completion of data analysis, approximately 8 months
Secondary outcomes (1)
Nurses' Views on the Clinical Acceptability and Usability of the Explainable Artificial Intelligence Decision-Support System
Nurses' views will be explored through individual semi-structured interviews. The interviews will be analyzed using thematic analysis to identify perceptions of clinical acceptability, usability, interpretability, potential benefits, concerns, and barriers to using the system.
Measured: From completion of nurse interviews through completion of qualitative data analysis, approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hatice akaltun
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Sponsor-investigator, hatice akaltun, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891689
- Sponsor's protocol ID
- VYYU-SBF-HAKALTUN-004
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared because the dataset includes sensitive clinical photographs and interview data. Although the data will be de-identified, sharing may pose a risk of re-identification. Only aggregated and anonymized results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging of Pressure Injuries Using Explainable Artificial Intelligence: A Prospective Clinical Decision Support Study With Expert Panel-Labeled Images
- ClinicalTrials.gov ID
- NCT07891689
- Acronym / sponsor ID
- VYYU-SBF-HAKALTUN-004
- Conditions
- Pressure Injury
- Keywords
- Pressure injury staging, Explainable artificial intelligence, Machine learning, Clinical decision support, nurses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- hatice akaltunUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 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 prospective observational mixed-methods study aims to develop and evaluate an explainable artificial intelligence model for staging pressure injuries using standardized clinical photographs and expert panel-labeled images from adult patients. The study will also explore nurses' views on the clinical acceptability and usability of the decision-support system through semi-structured interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Patients with Pressure Injuries | – | –Adult patients with pressure injuries whose standardized clinical photographs and clinical data will be collected prospectively. Pressure injuries will be independently staged by an expert panel, and the images will be used to develop and evaluate an explainable artificial intelligence model. No intervention will be administered. |
| Nurses Participating in Interviews | – | –Approximately 10-15 nurses working in intensive care and surgical units who provide pressure injury care will participate in individual semi-structured interviews. The interviews will explore their views on the clinical acceptability, usability, interpretability, and potential use of the explainable artificial intelligence decision-support system. No intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18 years or older with at least one pressure injury who are receiving care in the participating clinical units. Standardized clinical photographs and clinical data will be collected prospectively. In addition, approximately 10-15 nurses working in intensive care or surgical units and involved in pressure injury care will be invited to participate in individual semi-structured interviews. Patients and nurses will participate voluntarily after providing informed consent.
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Patients with at least one pressure injury.
- Patients whose pressure injury can be photographed according to the study protocol.
- Patients or legally authorized representatives who provide informed consent.
- Nurses working in intensive care or surgical units.
Key exclusion criteria (5 listed)
- Patients who do not provide informed consent.
- Patients whose clinical condition does not allow the photography procedure.
- Images that are technically inadequate or do not meet the study quality criteria.
- Nurses who do not provide informed consent.
- Nurses who are unable to complete the interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the Explainable Artificial Intelligence Model in Pressure Injury Staging
Time frame: From completion of image collection through completion of data analysis, approximately 8 months
The proportion of pressure injury images correctly staged by the explainable artificial intelligence model compared with the reference staging determined by the expert panel. Accuracy will be calculated as the number of correctly classified images divided by the total number of evaluable images.
1 secondary outcome
Nurses' Views on the Clinical Acceptability and Usability of the Explainable Artificial Intelligence Decision-Support System
Time frame: From completion of nurse interviews through completion of qualitative data analysis, approximately 4 months
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 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared because the dataset includes sensitive clinical photographs and interview data. Although the data will be de-identified, sharing may pose a risk of re-identification. Only aggregated and anonymized results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury, run by hatice akaltun 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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 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?
Contact Hatice Akaltun, lecturer dr (0 (432) 444 50 65 ext. 21242, haticeakaltun@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Explainable Artificial Intelligence Model in Pressure Injury Staging (time frame: From completion of image collection through completion of data analysis, approximately 8 months). 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 23 Oct 2026.