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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:
The clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinicgram Euclides | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa del Mar Martà Ejarque | Hospital University Sagrat Cor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skilled Skin S.L. | Barcelona | 08029 | Spain |
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|
| 1 day (at the end of the study) |
| ID | Term |
|---|---|
| D006406 | Hematoma |
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| D000072836 | Surgical Wound |
| D012883 | Skin Ulcer |
| D017719 | Diabetic Foot |
| D000544 | Alzheimer Disease |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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