跳至主要内容
临床试验/NCT05165758
NCT05165758已完成不适用

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

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Compare the levels of quality of life in diabetic subjects with and without foot ulcer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Compare the levels of quality of life in diabetic subjects with and without foot ulcer

时间窗: 6 months

The primary endpoint will be the score on the mental health dimension of the SF-36 score

次要结局

  • Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer(6 months)
  • Compare the levels of precarity in diabetic subjects with and without foot ulcer(6 months)
  • Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer(6 months)
  • Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer(6 months)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验