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)

NCT05846152 | Unknown DMC

• 1 other identifier: 2022-A01546-37
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Wound Healing

Keywords

Wound; Healing; Surface; Tissue content

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Eye by the principal investigator

  During the study inclusion visit

• Ruler by the principal investigator

  During the study inclusion visit

• Eye by the second investigator

  During the study inclusion visit

• Ruler by the second investigator

  During the study inclusion visit

• WoundCare (AKA WoundTrack) the second investigator

  During the study inclusion visit

Study Arms (1)

WoundCare medical device

EXPERIMENTAL

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

Device: Intervention

Interventions

Intervention 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.

WoundCare medical device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Guillaume Maxant, Dr

  HAGUENAU Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Maxant, Dr

CONTACT

0033388063096; guillaume.maxant@ch-haguenau.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: April 30, 2023
• Primary Completion: May 2, 2023
• Study Completion: May 31, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share