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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cross-cultural and Psychometric Validation of the RESVECH 2.0 Scale for the Assessment of Chronic Wounds in the French West Indies.

Conditions
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Chronic Wounds

Intervention / Treatment
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* Other: Patients with chronic wound of the lower limbs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The rating scale will be passed at three different times, day 1, day 15 and day 75.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with chronic wound of the lower limbs<br>Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center | Other: Patients with chronic wound of the lower limbs<br>* The rating scale will be passed at three different times, day 1, day 15 and day 75.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Before the start of recruitment | 
| Psychometric validation of the RESVECH 2.0 scale. | Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies | 15 days post inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,