← Back to all trials
Recruiting
NCT05729334
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Conditions: Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer, Venous Ulcer, Arterial Ulcer, Diabetic Neuropathic Ulcer, Ischemic Ulcer, Surgical Wound, Ulcer, Skin, Diabetic Foot Ulcer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 65
Sponsor: Skilled Skin S.L.
Location: Spain
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 EuclidesDigital planimetry with Adobe PhotoshopThe clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.
Eligibility Criteria
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.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.4. Subjects who have neoplastic, tumor, or pre-cancerous skin lesions. 5. Subjects presenting skin carcinomas or other skin lesions of confirmed malignancy (after differential diagnosis and screening of the potentially malignant lesion by clinical gross dermatology, dermatoscopy, microscopic dermatopathology, biopsy, or similar).6. Subjects presenting skin lesions with excessive exudate that may obscure part of the skin lesion and its outline.7. Subjects who suffer from movement disorders in the area where the skin lesion is located.8. Subjects who may have allergies to the plastic of the external caliper or other skin irritations.
Source: ClinicalTrials.gov (NCT05729334). StuddyBuddy aggregates publicly available trial information.