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

Diabetes Clinical Trial

— QVP-Dia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165758
• Other study ID #: 21_RIPH3-04
• Status: Completed
• Start date: January 21, 2022
• Est. completion date: June 17, 2022

Study information

• Verified date: September 2022
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Self-assessment questionnaires
Subjects will pass the SF-36 score (mental health items) and the EPICES index

Locations

Country	Name	City	State
France	University Hospital Center of Martinique	Fort-de-France	Martinique

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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