Pressure UlcersNCT07743385
Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study
A study testing AI Grid Image Recognition Measurement and Traditional Manual Grid Counting Measurement in people with Pressure Ulcers and Pressure Injuries, run by Affiliated Hospital of Nantong University at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn if AI grid image recognition can measure pressure ulcer wound area accurately and efficiently in adult patients with pressure ulcers. The main questions it aims to answer are: Can AI grid image recognition shorten the single measurement time of pressure ulcer wound area? Is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Pressure Injuries
- What is being tested?
- AI Grid Image Recognition Measurement and Traditional Manual Grid Counting Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 14 Jul 2026to 30 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old;
- Clinically diagnosed pressure injury of stage I-IV;
- Patients or legal guardians sign informed consent;
- Able to complete wound image acquisition.
Who cannot join
- Wounds with severe bleeding, active infection or extensive necrotic tissue unsuitable for film attachment;
- Patients with severe skin allergic diseases who cannot tolerate transparent grid film;
- Patients unable to cooperate with image collection;
- Pregnant women;
- Patients participating in other concurrent wound intervention trials.
- -
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
the Second Affiliated Hospital of Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310009
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
About this study
The goal of this clinical trial is to learn if AI grid image recognition can measure pressure ulcer wound area accurately and efficiently in adult patients with pressure ulcers. The main questions it aims to answer are:
- Can AI grid image recognition shorten the single measurement time of pressure ulcer wound area?
- Is the wound area measured by AI grid image recognition consistent with the result from traditional manual grid counting? Researchers will compare AI grid image recognition measurement with traditional manual grid counting measurement on the same pressure ulcer wound image collected at a single time point to see if AI recognition achieves comparable accuracy with less operation time.
Read more
Participants will:
- Have standardized transparent grid dressing applied on their pressure ulcer wound
- Undergo one-time wound image collection
- Receive sequential wound area measurement using both methods on the captured single wound image
Read the detailed description
This is a single-arm, self-controlled clinical trial enrolling adult inpatients with pressure ulcers. All enrolled subjects receive routine standardized wound care. A sterile transparent dressing printed with uniform standard grids will be applied onto the pressure ulcer wound surface for one-time image capture. Based on the single acquired wound image, two area measurement approaches will be performed sequentially: automated measurement via the AI grid image recognition system and manual measurement using the traditional grid counting method. The primary outcomes include single measurement operation time and the consistency of wound area results obtained from the two measurement techniques. All measurement data will be collected and statistically analyzed to verify whether AI grid recognition can achieve rapid and reliable area assessment of pressure ulcers in clinical settings.
- Conditions
- Pressure Ulcers, Pressure Injuries
- Being tested
- AI Grid Image Recognition Measurement, Traditional Manual Grid Counting Measurement
- Keywords
- Wound Assessment, Wound Area Measurement, AI Image Recognition, Grid Counting, Wound Measurement Film
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Grid Image Recognition MeasurementDiagnostic test
A sterile transparent grid measurement film (single grid area 0.25 cm²) is attached to the pressure ulcer wound. After wound image acquisition, the AI system automatically identifies grids covered by the wound to calculate pressure ulcer wound area.
Traditional Manual Grid Counting MeasurementDiagnostic test
Based on the same wound photo with transparent grid film, trained clinical staff manually count grids covered by pressure ulcer; grids covered more than half are counted, grids less than half covered are excluded to calculate wound area.
| Study group | Role | What they receive |
|---|---|---|
| Single Wound Measurement Group | Experimental | All participants in this group receive standardized pressure ulcer wound measurement with a sterile transparent grid film at one single time point. After wound image capture, two measurement methods are carried out successively: AI grid intelligent recognition measurement and traditional manual grid counting measurement. The study compares the operation time and measurement consistency of the two evaluation methods on the same wound. Receives: Diagnostic Test: AI Grid Image Recognition Measurement; Diagnostic Test: Traditional Manual Grid Counting Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure injury wound area
To compare pressure injury area values obtained by AI automatic grid recognition measurement and manual grid counting gold standard.
Measured: Baseline
Secondary outcomes (1)
Wound measurement operation duration
To compare the time consumed for completing one pressure injury area assessment between the AI measurement group and manual measurement group
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start14 Jul 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm self-controlled clinical trial. All enrolled participants are assigned to one single group. On the same pressure ulcer wound at a single time point, two wound area measurement methods are performed sequentially: AI grid image recognition measurement and traditional manual grid counting measurement. This design compares the operation efficiency and measurement consistency of the two methods within the same subject, eliminating inter-subject confounding factors.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Honglei Wu, Affiliated Hospital of Nantong University
- Investigators
- Honglei Wu, postgraduate, Study director, Affiliated Hospital of Nantong UniversityYajun Li, postgraduate, Principal investigator, Hospital of Bengbu Medical UniversityMeijuan Lan, postgraduate, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743385
- Sponsor's protocol ID
- 2026-K228-01
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data contains sensitive clinical information of patients. Considering the requirements of medical privacy protection and the limited research scope of this project, we do not plan to share raw individual participant data with other researchers. Aggregated study results may be published in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study
- ClinicalTrials.gov ID
- NCT07743385
- Acronym / sponsor ID
- 2026-K228-01
- Conditions
- Pressure Ulcers, Pressure Injuries
- Keywords
- Wound Assessment, Wound Area Measurement, AI Image Recognition, Grid Counting, Wound Measurement Film
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Aug 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.
The goal of this clinical trial is to learn if AI grid image recognition can measure pressure ulcer wound area accurately and efficiently in adult patients with pressure ulcers. The main questions it aims to answer are:
- Can AI grid image recognition shorten the single measurement time of pressure ulcer wound area?
- Is the wound area measured by AI grid image recognition consistent with the result from traditional manual grid counting? Researchers will compare AI grid image recognition measurement with traditional manual grid counting measurement on the same pressure ulcer wound image collected at a single time point to see if AI recognition achieves comparable accuracy with less operation time.
Participants will:
- Have standardized transparent grid dressing applied on their pressure ulcer wound
- Undergo one-time wound image collection
- Receive sequential wound area measurement using both methods on the captured single wound image
Detailed description
This is a single-arm, self-controlled clinical trial enrolling adult inpatients with pressure ulcers. All enrolled subjects receive routine standardized wound care. A sterile transparent dressing printed with uniform standard grids will be applied onto the pressure ulcer wound surface for one-time image capture. Based on the single acquired wound image, two area measurement approaches will be performed sequentially: automated measurement via the AI grid image recognition system and manual measurement using the traditional grid counting method. The primary outcomes include single measurement operation time and the consistency of wound area results obtained from the two measurement techniques. All measurement data will be collected and statistically analyzed to verify whether AI grid recognition can achieve rapid and reliable area assessment of pressure ulcers in clinical settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm self-controlled clinical trial. All enrolled participants are assigned to one single group. On the same pressure ulcer wound at a single time point, two wound area measurement methods are performed sequentially: AI grid image recognition measurement and traditional manual grid counting measurement. This design compares the operation efficiency and measurement consistency of the two methods within the same subject, eliminating inter-subject confounding factors.
| Arm | Type | Receives |
|---|---|---|
| Single Wound Measurement Group | Experimental | Diagnostic Test: AI Grid Image Recognition Measurement, Diagnostic Test: Traditional Manual Grid Counting MeasurementAll participants in this group receive standardized pressure ulcer wound measurement with a sterile transparent grid film at one single time point. After wound image capture, two measurement methods are carried out successively: AI grid intelligent recognition measurement and traditional manual grid counting measurement. The study compares the operation time and measurement consistency of the two evaluation methods on the same wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- Wounds with severe bleeding, active infection or extensive necrotic tissue unsuitable for film attachment;
- Patients with severe skin allergic diseases who cannot tolerate transparent grid film;
- Patients unable to cooperate with image collection;
- Pregnant women;
- Patients participating in other concurrent wound intervention trials.
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 |
|---|---|---|
| AI Grid Image Recognition MeasurementA sterile transparent grid measurement film (single grid area 0.25 cm²) is attached to the pressure ulcer wound. After wound image acquisition, the AI system automatically identifies grids covered by the wound to calculate pressure ulcer wound area. | Diagnostic test | Single Wound Measurement Group |
| Traditional Manual Grid Counting MeasurementBased on the same wound photo with transparent grid film, trained clinical staff manually count grids covered by pressure ulcer; grids covered more than half are counted, grids less than half covered are excluded to calculate wound area. | Diagnostic test | Single Wound Measurement Group |
Primary outcome
Pressure injury wound area
Time frame: Baseline
To compare pressure injury area values obtained by AI automatic grid recognition measurement and manual grid counting gold standard.
1 secondary outcome
Wound measurement operation duration
Time frame: Baseline
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 4 Aug 2026.
- Individual participant dataSharing planned: No. The individual participant data contains sensitive clinical information of patients. Considering the requirements of medical privacy protection and the limited research scope of this project, we do not plan to share raw individual participant data with other researchers. Aggregated study results may be published in academic journals.
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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.
Honglei Wu, postgraduate study director
Affiliated Hospital of Nantong University
Yajun Li, postgraduate principal investigator
Hospital of Bengbu Medical University
Meijuan Lan, postgraduate study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Grid Image Recognition Measurement and Traditional Manual Grid Counting Measurement in people with Pressure Ulcers and Pressure Injuries, run by Affiliated Hospital of Nantong University at 3 sites in China.
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 4 inclusion and 6 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Pressure injury wound area (time frame: Baseline). 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 4 Aug 2026.