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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)

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05846152
Acronym
PIXAIRE_I
Enrollment
42
Registered
2023-05-06
Start date
2023-04-30
Completion date
2025-05-31
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Keywords

Wound, Healing, Surface, Tissue content

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

Interventions

DEVICEIntervention

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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
WoundCare (AKA WoundTrack) the principal investigatorDuring the study inclusion visitSurface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator
Transparent sheet by principal investigatorDuring the study inclusion visitSurface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator

Secondary

MeasureTime frameDescription
Eye by the second investigatorDuring the study inclusion visitSurface (cm2) is evaluated by the eye of the second investigator
Ruler by the second investigatorDuring the study inclusion visitSurface (cm2) is evaluated using a ruler by the second investigator
Eye by the principal investigatorDuring the study inclusion visitSurface (cm2) is evaluated by the eye of the principal investigator
Transparent sheet by second investigatorDuring the study inclusion visitSurface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the second investigator
WoundCare (AKA WoundTrack) the second investigatorDuring the study inclusion visitSurface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator
Ruler by the principal investigatorDuring the study inclusion visitSurface (cm2) is evaluated using a ruler by the principal investigator

Contacts

Primary ContactGuillaume Maxant, Dr
guillaume.maxant@ch-haguenau.fr0033388063096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026