Clinical trial NCT05165758: Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique
Official title: Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus
Foot Ulcer, Diabetic
Diabetes Complications
Keywords: Diabete
Diabete complications
Diabetic foot ulcer
socio-economic disparities
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic subjects

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.

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.

Primary outcomes:
measure: Compare the levels of quality of life in diabetic subjects with and without foot ulcer
timeFrame: 6 months
Secondary outcomes:
measure: Compare the levels of precarity in diabetic subjects with and without foot ulcer
timeFrame: 6 months
measure: Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer
timeFrame: 6 months
measure: Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer
timeFrame: 6 months
measure: Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: University Hospital Center of Martinique
state: Martinique
Study officials:
affiliation: University Hospital Center of Martinique
name: Miguel BOURGADE, MD
role: PRINCIPAL_INVESTIGATOR
References: