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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05491291
Acronym
VALRESCIC
Enrollment
120
Registered
2022-08-08
Start date
2022-11-30
Completion date
2024-08-31
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Wounds

Keywords

Chronic wounds, RESVECH 2.0, Wound assesment tool, cross-cultural validation,

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.

Interventions

OTHERPatients with chronic wound of the lower limbs

The rating scale will be passed at three different times, day 1, day 15 and day 75.

Sponsors

University Hospital Center of Martinique
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

The rating scale will be passed at three different times, day 1, day 15 and day 75.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cultural adaptation of the RESVECH 2.0 scale.Before the start of recruitmentValidation 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 inclusionScientific validation of the french version of the scale RESVECH 2.0 in French West Indies

Countries

Martinique

Contacts

Primary ContactJocelyne CRASPAG, MSc
jocelyne.craspag@chu-martinique.fr0596592698
Backup ContactMaria CANO SANCHEZ, RN
maria.canosanchez@chu-martinque.fr0596553545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026