Clinical trial NCT05729334: Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Official title: Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Traumatic Ulcer
Hematoma
Pressure Ulcer
Venous Ulcer
Arterial Ulcer
Diabetic Neuropathic Ulcer
Ischemic Ulcer
Surgical Wound
Ulcer, Skin
Diabetic Foot Ulcer
Keywords: lesion skin
skin lesion
skin ulcer
wound area measurement
access
app
assessment
availability
correlation
mobile app
pressure ulcer
reliability
reproducibility
validity
wound
wound assessment
skin lesion area
measurement
calculation
Moisture Associated Skin Damage (MASD)
Lead sponsor: Skilled Skin S.L.
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. The subject must give written informed consent prior to any procedure related to the clinical investigation.
2. Adult person 18 years of age or older.
3. The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
4. The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
5. 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.
6. The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
7. Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
8. 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:

1. The subject is currently participating in another clinical investigation.
2. 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.

Primary outcomes:
measure: Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
timeFrame: 1 day
measure: Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
timeFrame: 1 day
measure: Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
timeFrame: 1 day
Secondary outcomes:
measure: Usability of the investigational software Clinicgram Euclides.
timeFrame: 1 day (at the end of the study)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Skilled Skin S.L.
Study officials:
affiliation: Hospital University Sagrat Cor
name: María del Mar Martí Ejarque
role: PRINCIPAL_INVESTIGATOR
References: