Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique

NCT ID: NCT05165758

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2022-06-17

Brief Summary

The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.

Detailed Description

Diabetes is one of the most frequent pathologies in Martinique (French West Indies) in terms of prevalence, as are its complications. The diabetic foot ulcer is a real public health problem considering its impact on the island.

It has already been shown that diabetic patients have a lower quality of life than the overall population. It is now time to compare the quality of life of diabetics with and without foot ulcer in Martinique.

Such a complication has a social impact that should not be overlooked in primary, secondary and tertiary prevention.

Conditions

Diabetes; Diabetes Mellitus; Foot Ulcer, Diabetic; Diabetes Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic subjects without foot ulcer

27 diabetic subjects without foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)

Self-assessment questionnaires

Intervention Type: OTHER

Subjects will pass the SF-36 score (mental health items) and the EPICES index

Diabetic subjects with foot ulcer

54 diabetic subjects presenting foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)

Self-assessment questionnaires

Intervention Type: OTHER

Subjects will pass the SF-36 score (mental health items) and the EPICES index

Interventions

Self-assessment questionnaires

Subjects will pass the SF-36 score (mental health items) and the EPICES index

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• People of 18 years old and over,
• Diabetics living in Martinique,
• Patient having been informed of the research,
• Patient agreeing to participate in the study.

Exclusion Criteria

• Minor patient,
• Hospitalized patients during inclusion phase,
• Patients with confusional syndrome,
• Patient presenting a cognitive state making it difficult to complete the questionnaire,
• Patient under legal protection, under guardianship or under curatorship,
• Patient who refused to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel BOURGADE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Martinique

Locations

University Hospital Center of Martinique

Fort-de-France, Martinique, France

Countries

France

Other Identifiers

21_RIPH3-04

Identifier Type: -

Identifier Source: org_study_id