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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Device: Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Maxant, Dr; Phone Number: 0033388063096; Email: guillaume.maxant@ch-haguenau.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WoundCare medical device; Unique arm. The patients undergo all interventions planned in the study.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WoundCare (AKA WoundTrack) the principal investigator	Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator	During the study inclusion visit
Transparent sheet by principal investigator	Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator	During the study inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye by the principal investigator	Surface (cm2) is evaluated by the eye of the principal investigator	During the study inclusion visit
Ruler by the principal investigator	Surface (cm2) is evaluated using a ruler by the principal investigator	During the study inclusion visit
Eye by the second investigator	Surface (cm2) is evaluated by the eye of the second investigator	During the study inclusion visit
Ruler by the second investigator	Surface (cm2) is evaluated using a ruler by the second investigator	During the study inclusion visit
WoundCare (AKA WoundTrack) the second investigator	Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator	During the study inclusion visit
Transparent sheet by second investigator	Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the second investigator	During the study inclusion visit

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Guillaume Maxant, Dr, HAGUENAU Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2023
• Primary Completion (Anticipated): May 2, 2023
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Wound; Healing; Surface; Tissue content
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2022-A01546-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No