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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) (PIXAIRE_I)

Primary Purpose

Wound Healing

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wound Healing focused on measuring Wound, Healing, Surface, Tissue content

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    WoundCare medical device

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    WoundCare (AKA WoundTrack) the principal investigator
    Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator
    Transparent sheet by principal investigator
    Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator

    Secondary Outcome Measures

    Eye by the principal investigator
    Surface (cm2) is evaluated by the eye of the principal investigator
    Ruler by the principal investigator
    Surface (cm2) is evaluated using a ruler by the principal investigator
    Eye by the second investigator
    Surface (cm2) is evaluated by the eye of the second investigator
    Ruler by the second investigator
    Surface (cm2) is evaluated using a ruler by the second investigator
    WoundCare (AKA WoundTrack) the second investigator
    Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator
    Transparent sheet by second investigator
    Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the second investigator

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05846152
    Brief Title
    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)
    Acronym
    PIXAIRE_I
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 30, 2023 (Anticipated)
    Primary Completion Date
    May 2, 2023 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Healing
    Keywords
    Wound, Healing, Surface, Tissue content

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WoundCare medical device
    Arm Type
    Experimental
    Arm Description
    Unique arm. The patients undergo all interventions planned in the study.
    Intervention Type
    Device
    Intervention Name(s)
    Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    WoundCare (AKA WoundTrack) the principal investigator
    Description
    Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator
    Time Frame
    During the study inclusion visit
    Title
    Transparent sheet by principal investigator
    Description
    Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator
    Time Frame
    During the study inclusion visit
    Secondary Outcome Measure Information:
    Title
    Eye by the principal investigator
    Description
    Surface (cm2) is evaluated by the eye of the principal investigator
    Time Frame
    During the study inclusion visit
    Title
    Ruler by the principal investigator
    Description
    Surface (cm2) is evaluated using a ruler by the principal investigator
    Time Frame
    During the study inclusion visit
    Title
    Eye by the second investigator
    Description
    Surface (cm2) is evaluated by the eye of the second investigator
    Time Frame
    During the study inclusion visit
    Title
    Ruler by the second investigator
    Description
    Surface (cm2) is evaluated using a ruler by the second investigator
    Time Frame
    During the study inclusion visit
    Title
    WoundCare (AKA WoundTrack) the second investigator
    Description
    Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator
    Time Frame
    During the study inclusion visit
    Title
    Transparent sheet by second investigator
    Description
    Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the second investigator
    Time Frame
    During the study inclusion visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guillaume Maxant, Dr
    Phone
    0033388063096
    Email
    guillaume.maxant@ch-haguenau.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guillaume Maxant, Dr
    Organizational Affiliation
    HAGUENAU Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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)

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