跳至主要内容
临床试验/NCT03782129
NCT03782129已完成不适用

Five-year Mortality Rate in People With Diabetic Foot Ulcer

Groupe Hospitalier Pitie-Salpetriere1 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
347
试验地点
1
主要终点
Mortality rate 5 years after DFU diagnosis

研究概览

简要总结

As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).

This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

详细描述

Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure.

Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.

But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010.

Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.

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

  • type 1 or 2 diabetes
  • consultation for new diabetic foot ulcer during the year 2010

排除标准

  • 未提供

结局指标

主要结局

Mortality rate 5 years after DFU diagnosis

时间窗: 5 years

Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.

次要结局

  • Risks factors correlated to mortality rate among DFU patients diagnosed in 2010(5 years)

研究者

发起方
Groupe Hospitalier Pitie-Salpetriere
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Groupe Hospitalier Pitie-Salpetriere

研究点 (1)

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