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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07619430
Enrollment
1000
Registered
2026-06-02
Start date
2026-06-08
Completion date
2027-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AI (Artificial Intelligence), Hard-to-heal Wounds, Pressure Injuries, Wound Care

Keywords

chronic wounds, wound assessment, medical AI, semantic segmentation, longitudinal image registration, marker-free, wound progression index, home-based care, telemedicine, clinical validation

Brief summary

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.

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.

Interventions

OTHERMarker-free wound image registration technology

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER
Industrial Technology Research Institute, Taiwan
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Agreement between marker-free and marker-based wound progression indicesUp to 6 monthsTo 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

MeasureTime frameDescription
Minimum image overlap threshold for reliable analysisUp to 6 monthsTo determine the minimum overlap ratio required to achieve statistically acceptable agreement.

Countries

Taiwan

Contacts

CONTACTHui-Hsiu Chang
huihsiu@gmail.com886-972655406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026