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

NCT07743385 | Active Not Recruiting

• 1 other identifier: 2026-K228-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Pressure Ulcers; Pressure Injuries

Keywords

Wound Assessment; Wound Area Measurement; AI Image Recognition; Grid Counting; Wound Measurement Film

Outcome Measures

Primary Outcomes (1)

• Pressure injury wound area

  To compare pressure injury area values obtained by AI automatic grid recognition measurement and manual grid counting gold standard.

  Baseline

Secondary Outcomes (1)

• Wound measurement operation duration

  Baseline

Study Arms (1)

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.

Diagnostic Test: AI Grid Image Recognition Measurement; Diagnostic Test: Traditional Manual Grid Counting Measurement

Interventions

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.

Single Wound Measurement Group

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.

Single Wound Measurement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (3)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

the Second Affiliated Hospital of Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Honglei Wu, postgraduate

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

• Yajun Li, postgraduate

  Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Meijuan Lan, postgraduate

  Second Affiliated Hospital, Zhejiang University, School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study adopts an open-label design. All participants, care providers, investigators and outcome assessors are aware of the measurement method being used. Blinding is not feasible due to the obvious differences in the operation procedures and implementation modes between the AI grid image recognition measurement and the traditional manual grid counting measurement.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nurse

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 3, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)