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

NCT05491291 | Unknown

• 1 other identifier: 20_RIPH23-27
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wounds

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients with chronic wound of the lower limbs

OTHER

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

Interventions

Patients with chronic wound of the lower limbs OTHER

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

Patients with chronic wound of the lower limbs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with critical ischemia of the lower limb concerned
• Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU de Martinique

Fort-de-France, 97261, Martinique

Location

Related Publications (2)

• Alvarez-Del-Rio 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.

  PMID: 31083854 RESULT

• Aragon-Sanchez J, Lipsky BA, Lazaro-Martinez 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.1464-5491.2010.03150.x.

  PMID: 21219428 RESULT

Related 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

Study Officials

• Maria CANO SANCHEZ, RN

  CHU de Martinique

  STUDY DIRECTOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

0596592698; jocelyne.craspag@chu-martinique.fr

Maria CANO SANCHEZ, RN

CONTACT

0596553545; maria.canosanchez@chu-martinque.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)