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

August 4, 2022 updated by: University Hospital Center of Martinique

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with chronic wound of the lower limbs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cultural adaptation of the RESVECH 2.0 scale.
Time Frame: Before the start of recruitment
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Before the start of recruitment
Psychometric validation of the RESVECH 2.0 scale.
Time Frame: 15 days post inclusion
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies
15 days post inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

  • Study Director: Maria CANO SANCHEZ, RN, CHU de Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20_RIPH23-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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