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 Details — Status: Completed

Administrative data

• NCT number: NCT05729334
• Other study ID #: CIP-EUCLIDES-01
• Status: Completed
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: April 2023
• Source: Skilled Skin S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 21, 2023
• Est. primary completion date: February 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Skilled Skin S.L.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Skilled Skin S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.	To assess the agreement/concordance of skin lesion area measurements between: the investigational software Clinicgram Euclides and digital planimetry using Adobe Photoshop, and; the investigational software Clinicgram Euclides and the ruler measurement using the Kundin method.	1 day
Primary	Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.	To assess the reproducibility of Clinicgram Euclides in the e of skin lesion area measurements using two different mobile devices: an iPhone and an iPad.	1 day
Primary	Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.	To assess the repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two consecutive measurements performed by the same investigator.	1 day
Secondary	Usability of the investigational software Clinicgram Euclides.	To evaluate the usability of the investigational software Clinicgram Euclides based on the completion of a usability questionnaire by each investigator who has used Clinicgram Euclides throughout the clinical investigation, and on the assessment of the time required to complete the calculation of the skin lesion area with each of the 3 methods (ruler measurement using Kundin method, investigational software Clinicgram Euclides, and digital planimetry using Adobe Photoshop).	1 day (at the end of the study)