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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05165758
Acronym
QVP-Dia
Enrollment
81
Registered
2021-12-21
Start date
2022-01-21
Completion date
2022-06-17
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Diabete, Diabete complications, Diabetic foot ulcer, socio-economic disparities

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.

Interventions

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

Sponsors

University Hospital Center of Martinique
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compare the levels of quality of life in diabetic subjects with and without foot ulcer6 monthsThe primary endpoint will be the score on the mental health dimension of the SF-36 score

Secondary

MeasureTime frameDescription
Compare the levels of precarity in diabetic subjects with and without foot ulcer6 monthsTo evaluate the level of precarity, the EPICES score will be calculated for both type of subjects.
Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer6 monthsTo 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 quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer6 monthsTo 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.
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer6 monthsTo 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026