AI-Based Wound Monitoring: Automated Wound Progression Assessment Via Marker-Free Image Sequence

May 27, 2026 updated by: National Taiwan University Hospital
This study aims to develop a low-cost, marker-free intelligent wound assessment system that can analyze wound photos taken with a standard smartphone. By comparing wound images over time, the system will generate a quantifiable Wound Progression Index (WPI) to provide objective feedback on whether a wound is improving, stable, or worsening. The long-term goal is to support early detection of wound deterioration and improve wound care in both clinical and home settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants receiving routine wound care will undergo standardized wound photography during dressing changes. Longitudinal wound images will be analyzed to develop and validate a marker-free wound progression assessment method. No treatment assignment or modification of standard clinical care will occur.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Yunlin
      • Douliu, Yunlin, Taiwan, 640
        • National Taiwan University Hospital Yunlin Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with hard-to-heal wounds located on body sites that can be fully captured within a single standardized image.

Description

Inclusion Criteria:

  • (1) Presence of a hard-to-heal wound that has remained unhealed for more than one month. (2)The wound can be photographed according to the standardized imaging protocol. (3)The participant was aged 18 years or older and provided informed consent personally or via a legally authorized representative, with a signed informed consent form.

Exclusion Criteria:

  • Wounds whose margins could not be fully included within the imaging field.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with hard-to-heal wounds
Other: Marker-free wound image registration technology
Marker-free longitudinal wound image registration and wound progression assessment using serial wound photographs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between marker-free and marker-based wound progression indices
Time Frame: Up to 6 months
To evaluate the agreement between the Marker-Free Wound Progression Index (WPI_MF) and the gold-standard marker-based Wound Progression Index (WPI_GS) derived from longitudinal wound photographs.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum image overlap threshold for reliable analysis
Time Frame: Up to 6 months
To determine the minimum overlap ratio required to achieve statistically acceptable agreement.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Industrial Technology Research Institute, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202603061RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

wound images

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

Requests must include a structured research proposal specifying the objectives, analysis plan, and data required. All requests will be reviewed by the corresponding investigator and the study's principal research team to ensure scientific validity, ethical compliance, and protection of participant confidentiality. Additional approval from an institutional review board or ethics committee may be required depending on the nature of the proposed analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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