NCT05491291

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital Center of Martinique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Wounds

Interventions

Type	Name	Description
OTHER	Patients with chronic wound of the lower limbs	The rating scale will be passed at three different times, day 1, day 15 and day 75.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-05-01
• Completion: 2024-08-01
• First posted: 2022-08-08
• Last updated: 2022-08-08

Locations

1 site across 1 country: Martinique