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NCT Number: NCT07743385

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

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria:
  • 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.

Exclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

AI Grid Image Recognition Measurement

Diagnostic 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 Measurement

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wound measurement operation duration

    Time frame: Baseline

    To compare the time consumed for completing one pressure injury area assessment between the AI measurement group and manual measurement group

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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