Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Heal … (NCT07211295) | Clinical Trial Compass
CompletedNot Applicable
Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Heal Wounds
Sweden25 participantsStarted 2025-07-01
Plain-language 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), wound depth (mm), and the estimation of the proportion of fibrin covering (slough) and necrosis (%) in real-world clinical settings for patients with hard-to-heal wounds. The study also seeks to validate the non-invasive method for measuring wound depth, as current standard care involves invasive probing of the wound to estimate depth - a practice that this investigational device is intended to replace with a digital, contact-free measurement approach.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Older than 18 years, men and women Difficult to heal wounds due to diabetes, VLU; Pressure wounds wound larger than 0.5 cm2
Exclusion Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy
Timeframe: During the study
2
Accurac, Precision, Mean absolute Error (MAE); Coefficient of Variation (CV); SD