Back to resultsClinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
Primary Purpose
Skin Lesion, Traumatic Ulcer, Hematoma
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clinicgram Euclides
Sponsored by
About this trial
This is an interventional device feasibility trial for Skin Lesion focused on measuring 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)
Eligibility Criteria
Inclusion Criteria: The subject must give written informed consent prior to any procedure related to the clinical investigation. Adult person 18 years of age or older. The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler. The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees). 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. The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion. Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located. 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: The subject is currently participating in another clinical investigation. 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.
Sites / Locations
- Skilled Skin S.L.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria
Arm Description
Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05729334
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
February 12, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skilled Skin S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria
Arm Type
Experimental
Arm Description
Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria.
Intervention Type
Device
Intervention Name(s)
Clinicgram Euclides
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
Description
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.
Time Frame
1 day
Title
Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
Description
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.
Time Frame
1 day
Title
Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
Description
To assess the repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two consecutive measurements performed by the same investigator.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Usability of the investigational software Clinicgram Euclides.
Description
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).
Time Frame
1 day (at the end of the study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must give written informed consent prior to any procedure related to the clinical investigation.
Adult person 18 years of age or older.
The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
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.
The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
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:
The subject is currently participating in another clinical investigation.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María del Mar Martí Ejarque
Organizational Affiliation
Hospital University Sagrat Cor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skilled Skin S.L.
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
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