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

April 12, 2023 updated by: Skilled Skin S.L.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08029
        • Skilled Skin S.L.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria
Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
Time Frame: 1 day

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
Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
Time Frame: 1 day
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
Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the investigational software Clinicgram Euclides.
Time Frame: 1 day (at the end of the study)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skilled Skin S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Actual)

February 12, 2023

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-EUCLIDES-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgical Wound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe