Skin LesionNCT05729334
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
A study testing Clinicgram Euclides in people with Skin Lesion and Traumatic Ulcer, run by Skilled Skin S.L. at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Lesion, Traumatic Ulcer, Hematoma
- What is being tested?
- Clinicgram Euclides
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 28 Nov 2022to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Clinicgram Euclides
- 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)
- Medical subject headings
- Hematoma, Pressure Ulcer, Varicose Ulcer, Surgical Wound, Skin Ulcer, Diabetic Foot, Alzheimer Disease, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinicgram EuclidesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria | Experimental | Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria. Receives: Device: Clinicgram Euclides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 1 day (at the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start28 Nov 2022
- Primary completion12 Feb 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skilled Skin S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María del Mar Martí Ejarque, Principal investigator, Hospital University Sagrat Cor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729334
- Sponsor's protocol ID
- CIP-EUCLIDES-01
- Status last verified
- Apr 2023
- First submitted
- 6 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
- ClinicalTrials.gov ID
- NCT05729334
- Acronym / sponsor ID
- CIP-EUCLIDES-01
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer, Venous Ulcer, Arterial Ulcer
- Keywords
- lesion skin, skin lesion, skin ulcer, wound area measurement, access, app, assessment, availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Skilled Skin S.L.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria | Experimental | Device: Clinicgram EuclidesSubjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinicgram EuclidesClinicgram 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. | Device | Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria |
Primary outcome
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.
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.
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 secondary outcome
Usability of the investigational software Clinicgram Euclides.
Time frame: 1 day (at the end of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María del Mar Martí Ejarque principal investigator
Hospital University Sagrat Cor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinicgram Euclides in people with Skin Lesion and Traumatic Ulcer, run by Skilled Skin S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides. (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.