An interventional study of Patients with chronic wound of the lower limbs in Chronic Wounds, sponsored by University Hospital Center of Martinique. Status unknown at 1 site in Martinique. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by University Hospital Center of Martinique · Not applicable, Interventional, and Other
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The rating scale will be passed at three different times, day 1, day 15 and day 75.
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
Time frame: 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
Time frame: 15 days post inclusion
Plan to share: No
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Center of Martinique