Status:
COMPLETED
Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Heal Wounds
Lead Sponsor:
University Hospital, Linkoeping
Conditions:
Difficult to Heal Wounds
Eligibility:
All Genders
19+ years
Brief Summary
This study aims to determine and evaluate the clinical accuracy, precision, and safety of SeeWound 2, an AI-driven wound assessment application, designed for the measurement of wound surface area (cm²...
Detailed Description
SeeWound 2 is a software-based medical device that utilises artificial intelligence to classify and quantify wound tissue types, specifically fibrin covering (slough) and necrosis, as well as to measu...
Eligibility Criteria
Inclusion
- Older than 18 years, men and women Difficult to heal wounds due to diabetes, VLU; Pressure wounds wound larger than 0.5 cm2
Exclusion
- Exclusion Criteria / Contraindications
- Use of SeeWound 2 is not intended for, or is contraindicated in, the following situations:
- Patients under 18 years of age. Wounds located in anatomical regions where the full wound surface and depth cannot be captured (e.g. deep fistulas, tunnels, or undermined areas not accessible through surface imaging).
- Wounds with excessive exudation or infection that prevents adequate visual assessment.
- Patients who are unable or unwilling to provide informed consent. Patients with a known allergy or adverse reaction to any component used in the image acquisition process (where applicable).
- Wounds with specific identifiable attributes (e.g. on the face, or containing birthmarks or tattoos) where ethical considerations regarding data handling apply.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 18 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07211295
Start Date
July 1 2025
End Date
September 18 2025
Last Update
October 7 2025
Active Locations (1)
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1
BRIVA, Intensive Care for Burns,
Linköping, Östergötland County, Sweden, 58185