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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Wounds
• Wounds and Injuries

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

External Links

•   A Coefficient of Agreement for Nominal Scales
•   Validation des échelles d'évaluation en médecine physique et de réadaptation : comment apprécier correctement leurs qualités psychométriques