Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique (QVP-Dia)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetes; Diabetes Complications; Foot Ulcer, Diabetic
• Intervention / Treatment: Other: Self-assessment questionnaires

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• France
  • Martinique
    • Fort-de-France, Martinique, France, 97261
      • University Hospital Center of Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Diabetic subjects

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Self-assessment questionnaires; 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)	Other: Self-assessment questionnaires; Subjects will pass the SF-36 score (mental health items) and the EPICES index

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the levels of precarity in diabetic subjects with and without foot ulcer	To evaluate the level of precarity, the EPICES score will be calculated for both type of subjects.	6 months
Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer	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.	6 months
Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer	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.	6 months
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer	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.	6 months

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Investigators: Principal Investigator: Miguel BOURGADE, MD, University Hospital Center of Martinique

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2022
• Primary Completion (ACTUAL): June 17, 2022
• Study Completion (ACTUAL): June 17, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (ACTUAL): December 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Diabete; Diabete complications; socio-economic disparities
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Ulcer; Diabetes Complications
• Other Study ID Numbers: 21_RIPH3-04

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