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Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions

Diabetic Foot Ulcer Clinical Trial

Official title:
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions

Clinical Trial 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.

Clinical Trial Description

The aim of the clinical investigation EUCLIDES-01 is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three skin lesion area measurement methods: - Ruler using the Kundin method, - Investigational software Clinicgram Euclides - Digital planimetry with Adobe Photoshop Clinicgram Euclides is a software that allows automatic calculation of skin lesion areas using a mobile device. It has two modes of operation (Euclides 2D and Euclides 3D). The sample size is 65 subjects. Up to three skin lesions can be included from the same subject. For this reason, the number of subjects may be smaller if more than one skin lesion is measured in certain subjects. EUCLIDES-01 is a pre-market, prospective, single-center, non-randomized clinical investigation with one arm of subjects intended to collect skin lesion area data for the comparison of the agreement among the results obtained between the three above-mentioned skin lesion area measurement methods. No patient follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05729334
Study type Interventional
Source Skilled Skin S.L.
Contact
Status Completed
Phase N/A
Start date November 28, 2022
Completion date March 21, 2023
View Details
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