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)

Wound Healing Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05846152
• Other study ID #: 2022-A01546-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2023
• Source: Central Hospital, Nancy, France
• Contact: Guillaume Maxant, Dr
• Phone: 0033388063096
• Email: guillaume.maxant[@]ch-haguenau.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: May 31, 2025
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WoundCare (AKA WoundTrack) the principal investigator	Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator	During the study inclusion visit
Primary	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	Eye by the principal investigator	Surface (cm2) is evaluated by the eye of the principal investigator	During the study inclusion visit
Secondary	Ruler by the principal investigator	Surface (cm2) is evaluated using a ruler by the principal investigator	During the study inclusion visit
Secondary	Eye by the second investigator	Surface (cm2) is evaluated by the eye of the second investigator	During the study inclusion visit
Secondary	Ruler by the second investigator	Surface (cm2) is evaluated using a ruler by the second investigator	During the study inclusion visit
Secondary	WoundCare (AKA WoundTrack) the second investigator	Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator	During the study inclusion visit
Secondary	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