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NCT05491291 Clinical Trial

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

Chronic Wounds Clinical Trial

— VALRESCIC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05491291
Other study ID # 20_RIPH23-27
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date August 2024

Study information
Verified date August 2022
Source University Hospital Center of Martinique
Contact Jocelyne CRASPAG, MSc
Phone 0596592698
Email jocelyne.craspag@chu-martinique.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date August 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Martinique CHU de Martinique Fort-de-France

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

References & Publications (2)

Álvarez-Del-Río 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. — View Citation

Aragón-Sánchez J, Lipsky BA, Lázaro-Martínez 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.1464-5491.2010.03 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Before the start of recruitment
Primary Psychometric validation of the RESVECH 2.0 scale. Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies 15 days post inclusion
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