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Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study

NCT07743385 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-07-14
Last updated
2026-08-04

Condition(s) studied

Pressure UlcersPressure Injuries

Investigational drug(s) / intervention(s)

AI Grid Image Recognition MeasurementTraditional Manual Grid Counting Measurement

AI Grid Image Recognition Measurement: 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 Measurement: 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 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Inclusion Criteria: 1. Aged ≥18 years old; 2. Clinically diagnosed pressure injury of stage I-IV; 3. Patients or legal guardians sign informed consent; 4. Able to complete wound image acquisition. Exclusion Criteria: 1. Wounds with severe bleeding, active infection or extensive necrotic tissue unsuitable for film attachment; 2. Patients with severe skin allergic diseases who cannot tolerate transparent grid film; 3. Patients unable to cooperate with image collection; 4. Pregnant women; 5. Patients participating in other concurrent wound intervention trials. Exclusion Criteria: \-

Primary outcome measure(s)

  • Pressure injury wound area — Baseline
    To compare pressure injury area values obtained by AI automatic grid recognition measurement and manual grid counting gold standard.

Trial sites (3)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
Affiliated Hospital of Nantong University Nantong Jiangsu
the Second Affiliated Hospital of Zhejiang University School of Medicine. Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07743385 on ClinicalTrials.gov ↗ ← All trials in China