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临床试验/NCT05133570
NCT05133570Unknown不适用

Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年10月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
1
主要终点
Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.

研究概览

简要总结

The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

详细描述

Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

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

  • -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days.
  • Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh
  • Agreement of the study no-objection form
  • Age greater than or equal to 18 years
  • Patient affiliated to a social security scheme

排除标准

  • -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent

结局指标

主要结局

Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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