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

Completed

• Conditions: Foot Ulcer, Diabetic; Diabetes; Diabetes Mellitus; Diabetes Complications
• Interventions: Other: Self-assessment questionnaires

• Registration Number: NCT05165758
• Lead Sponsor: University Hospital Center of Martinique

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.

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-01-21
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic subjects without foot ulcer	Self-assessment questionnaires	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)
Diabetic subjects with foot ulcer	Self-assessment questionnaires	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)

Primary Outcome Measures

Name	Time	Method
Compare the levels of quality of life in diabetic subjects with and without foot ulcer	6 months	The primary endpoint will be the score on the mental health dimension of the SF-36 score

Secondary Outcome Measures

Name	Time	Method
Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer	6 months	To evaluate the level of quality of life according to HbA1c, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.
Compare the levels of precarity in diabetic subjects with and without foot ulcer	6 months	To evaluate the level of precarity, the EPICES score will be calculated for both type of subjects.
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer	6 months	To evaluate the level of quality of life according to the antidiabetic treatment, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.
Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer	6 months	To evaluate the level of quality of life according to the duration of diabetes, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.

Trial Locations

Locations (1)

University Hospital Center of Martinique; 🇫🇷 Fort-de-France, Martinique, France