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

September 12, 2022 updated by: University Hospital Center of Martinique
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 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.
6 months
Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer
Time Frame: 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.
6 months
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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