Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions (NCT05729334) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Spain65 participantsStarted 2022-11-28
Plain-language summary
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods:
* Ruler using the Kundin method,
* Investigational software Clinicgram Euclides
* Digital planimetry with Adobe Photoshop
The clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.
Who can participate
Age range
18 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
. The subject must give written informed consent prior to any procedure related to the clinical investigation.
. Adult person 18 years of age or older.
. The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
. The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
. The subject has an external skin lesion located in an area that does not include an edge or curvature of the body, and that has no parts hidden by any device or treatment.
. The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
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
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
Timeframe: 1 day
2
Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
Timeframe: 1 day
3
Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
. Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
. Subjects can hold still, or not be prevented by pain from having still, for at least 10 seconds for the taking of the skin lesion photograph.
Exclusion criteria
. The subject is currently participating in another clinical investigation.
. Pregnant or breastfeeding women. Subjects who have medical, social, or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the investigation or impact the scientific robustness of the clinical investigation results.