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

NCT05729334 | Completed

• 1 other identifier: CIP-EUCLIDES-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (1)

• Usability of the investigational software Clinicgram Euclides.

  1 day (at the end of the study)

Study Arms (1)

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.

Device: Clinicgram Euclides

Interventions

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: * 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.

Subjects with skin lesions who meet all inclusion criteria and none of the exclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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).
• \. Subjects presenting skin lesions with excessive exudate that may obscure part of the skin lesion and its outline.
• \. Subjects who suffer from movement disorders in the area where the skin lesion is located.
• \. Subjects who may have allergies to the plastic of the external caliper or other skin irritations.

Sponsors & Collaborators

• Skilled Skin S.L.: lead

Study Sites (1)

Skilled Skin S.L.

Barcelona, 08029, Spain

Location

MeSH Terms

Conditions

Hematoma; Pressure Ulcer; Varicose Ulcer; Surgical Wound; Skin Ulcer; Diabetic Foot; Alzheimer Disease; Wounds and Injuries

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• María del Mar Martí Ejarque

  Hospital University Sagrat Cor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: November 28, 2022
• Primary Completion: February 12, 2023
• Study Completion: March 21, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

ES (1)