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Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique (VALRESCIC)

Primary Purpose

Chronic Wounds

Status
Not yet recruiting
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Patients with chronic wound of the lower limbs
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Wounds focused on measuring Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre.
  • Patients agreeing to participate in the study
  • Patients affiliated to a social security scheme

Exclusion Criteria:

  • Patients with critical ischemia of the lower limb concerned
  • Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty

Sites / Locations

  • CHU de Martinique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with chronic wound of the lower limbs

Arm Description

Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center

Outcomes

Primary Outcome Measures

Cultural adaptation of the RESVECH 2.0 scale.
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Psychometric validation of the RESVECH 2.0 scale.
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
August 4, 2022
Sponsor
University Hospital Center of Martinique
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1. Study Identification

Unique Protocol Identification Number
NCT05491291
Brief Title
Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique
Acronym
VALRESCIC
Official Title
Cross-cultural and Psychometric Validation of the RESVECH 2.0 Scale for the Assessment of Chronic Wounds in the French West Indies.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

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

5. Study Description

Brief Summary
Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.
Detailed Description
The VALRESCIC study aims to perform a cross-cultural and psychometric validation of the RESVECH 2.0 scale in order to be able to use it for monitoring wounds in both hospital and primary care settings in the French West Indies. The RESVECH 2.0 scale is a heterogeneous scale to monitor the evolution of a chronic wound. This scale was created in 2010 and consists of 6 items with response modalities ranging from 5 to 14. The interpretation of the scale parameters may differ depending on the cultural context. The RESVECH 2.0 scale has been validated in the Spanish language (in Spain and Colombia) to assess the progress towards healing of pressure ulcers and chronic wounds of the lower limbs. For the cross-cultural evaluation we will follow Beaton's methodology, which includes: translation, synthesis, retro-translation, expert committee review and pre-testing. For the psychometric validation, the following parameters will be measured: Feasibility and acceptability, validity, reliability, and sensitivity to change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds
Keywords
Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The rating scale will be passed at three different times, day 1, day 15 and day 75.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic wound of the lower limbs
Arm Type
Other
Arm Description
Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center
Intervention Type
Other
Intervention Name(s)
Patients with chronic wound of the lower limbs
Intervention Description
The rating scale will be passed at three different times, day 1, day 15 and day 75.
Primary Outcome Measure Information:
Title
Cultural adaptation of the RESVECH 2.0 scale.
Description
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Time Frame
Before the start of recruitment
Title
Psychometric validation of the RESVECH 2.0 scale.
Description
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies
Time Frame
15 days post inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre. Patients agreeing to participate in the study Patients affiliated to a social security scheme Exclusion Criteria: Patients with critical ischemia of the lower limb concerned Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne CRASPAG, MSc
Phone
0596592698
Ext
+596
Email
jocelyne.craspag@chu-martinique.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maria CANO SANCHEZ, RN
Phone
0596553545
Ext
+596
Email
maria.canosanchez@chu-martinque.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria CANO SANCHEZ, RN
Organizational Affiliation
CHU de Martinique
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria CANO SANCHEZ, RN
Phone
0596553545
Ext
+596
Email
maria.canosanchez@chu-martinique.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31083854
Citation
Alvarez-Del-Rio RF. Factors Associated to the Cicatrization Success of Lower-Limb Ulcer of Venous Etiology. Invest Educ Enferm. 2018 Sep;36(3). doi: 10.17533/udea.iee.v36n3e08.
Results Reference
result
PubMed Identifier
21219428
Citation
Aragon-Sanchez J, Lipsky BA, Lazaro-Martinez JL. Diagnosing diabetic foot osteomyelitis: is the combination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet Med. 2011 Feb;28(2):191-4. doi: 10.1111/j.1464-5491.2010.03150.x.
Results Reference
result
Links:
URL
https://www.semanticscholar.org/paper/A-Coefficient-of-Agreement-for-Nominal-Scales-Cohen/9e463eefadbcd336c69270a299666e4104d50159
Description
A Coefficient of Agreement for Nominal Scales
URL
https://www.em-consulte.com/article/34264/validation-des-echelles-d-evaluation-en-medecine-p
Description
Validation des échelles d'évaluation en médecine physique et de réadaptation : comment apprécier correctement leurs qualités psychométriques

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Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique

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