NCT05729334

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Skilled Skin S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Skin Lesion
• Traumatic Ulcer
• Hematoma
• Pressure Ulcer
• Venous Ulcer
• Arterial Ulcer
• Diabetic Neuropathic Ulcer
• Ischemic Ulcer
• Surgical Wound
• Ulcer, Skin
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Clinicgram Euclides	Clinicgram Euclides is a software that allows automated calculation of the area of skin lesions using a mobile device. Three different photographs will be taken of the subject's skin lesion. The area of the skin lesion will be calculated using the photograph of the skin lesion, and: * for EUCLIDES 2D, an external marker. The investigator will outline the skin lesion and the external marker in the photograph prior to the calculation of the skin lesion area. * for EUCLIDES 3D, a two reference points selected by the investigator.

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-02-12
• Completion: 2023-03-21
• First posted: 2023-02-15
• Last updated: 2023-04-14

Locations

1 site across 1 country: Spain