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

University Hospital Center of Martinique

Status: Not yet enrolling

Conditions: Chronic Wounds

Treatments: Other: Patients with chronic wound of the lower limbs

Study type: Interventional

Funder types: Other

Identifiers

NCT05491291

20_RIPH23-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Patients with chronic wound of the lower limbs

Other group

Description:

Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center

Treatment:

Other: Patients with chronic wound of the lower limbs