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NCT07743385

Overview

NCT ID: NCT07743385
Lead Sponsor: Affiliated Hospital of Nantong UniversityOTHER
Official Title: Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study
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

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 14, 2026Actual
Primary Completion Date: Sep 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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:

-

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: The First Affiliated Hospital of Bengbu Medical University

Similar Studies

Participant Group/Arms

Single Wound Measurement GroupExperimental

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