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NCT Number: NCT07619430

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

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.

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Key information

Conditions

Hard-to-heal Wounds AI (Artificial Intelligence) Pressure Injuries Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital Yunlin branch

Douliu, Yunlin, 640, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Marker-free wound image registration technology

Other

Marker-free longitudinal wound image registration and wound progression assessment using serial wound photographs.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsiu Chang

CONTACT

[email protected]

886-972655406

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Industrial Technology Research Institute, Taiwan

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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