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

Not Applicable

• Conditions: Chronic Wounds

• Registration Number: NCT05491291
• Lead Sponsor: University Hospital Center of Martinique

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Study Start: 2022-11
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cultural adaptation of the RESVECH 2.0 scale.	Before the start of recruitment	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.	15 days post inclusion	Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies

Trial Locations

Locations (1)

CHU de Martinique; 🇲🇶 Fort-de-France, Martinique