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Completed

NCT Number: NCT05165758

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

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Foot Ulcer, Diabetic Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Center of Martinique

Fort-de-France, Martinique, 97261, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

self-assessment questionnaires

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: QVP-Dia

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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