Study of the Concordance of the Measurements Between the Evaluation of the Area of a Wound by the Technique of Transparent (Gold Standard) Compared to the Evaluation of the Area by the Algorithm of a Decision Support System (Wound-size)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2025-05-31

Brief Summary

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The goal of this clinical trial is to compare the evaluation of a wound area and wound tissue content made by different methods on patient population with need for directed wound healing.

The main question test of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (Gold standard) compared to the evaluation of the area by the algorithm of a decision support system (WoundSize)

Patient wounds will be examined:

* by eye by the principal investigator
* using a ruler by the principal investigator
* by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator
* tracing the outline of the wound using a transparent sheet by the principal investigator
* by eye by a second investigator
* using a ruler by a second investigator
* by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.
* tracing the outline of the wound using a transparent sheet by the second investigator

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Detailed Description

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Conditions

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Wound Healing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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WoundCare medical device

Unique arm. The patients undergo all interventions planned in the study.

Group Type EXPERIMENTAL

Intervention

Intervention Type DEVICE

Patient wounds will be examined:

* by eye by the principal investigator
* using a ruler by the principal investigator
* by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator
* by eye by a second investigator
* using a ruler by a second investigator
* by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.

Interventions

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Intervention

Patient wounds will be examined:

* by eye by the principal investigator
* using a ruler by the principal investigator
* by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator
* by eye by a second investigator
* using a ruler by a second investigator
* by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient suffering from a wound requiring controlled healing ranging from 4 to 150 cm²
* Age greater than or equal to 18 years old
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Person having received complete information on the organization of the research and having signed informed consent.
* Wound that can be taken in one photo in its entirety.

Exclusion Criteria

* Person with a medical condition which, in the judgment of the investigator, is not compatible with participation in the study
* Wound on a part of the body that would make the person participating in the photos of the wound identifiable (tattoo, piercing, birthmark, etc.).
* Several wounds are in the photo.
* Pregnant, parturient or breastfeeding women
* Person deprived of liberty by a judicial or administrative decision
* Adult subject to a measure of legal protection (guardianship, curatorship, safeguard of justice) or unable to express their consent, persons subject to psychiatric care.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No