Clinical trial NCT05491291: Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Wounds
Keywords: Chronic wounds
RESVECH 2.0
Wound assesment tool
cross-cultural validation,
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The rating scale will be passed at three different times, day 1, day 15 and day 75.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Cultural adaptation of the RESVECH 2.0 scale.
timeFrame: Before the start of recruitment
measure: Psychometric validation of the RESVECH 2.0 scale.
timeFrame: 15 days post inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU de Martinique
name: Maria CANO SANCHEZ, RN
role: STUDY_DIRECTOR
References:
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.
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.