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临床试验/NCT02385903
NCT02385903终止2 期

Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
55
试验地点
1
主要终点
Amputation rate

研究概览

简要总结

Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Ischemic wound of the lower limb
  • •Minimum 50% necrosis
  • •Arteriopathy with ABI<0.7 or >1.3 with radiographic examinations
  • •No revascularisation procedure possible for any reasons
  • •No urgent amputation need
  • •Amputation considered in a short term
  • •Non life-threatened patients

排除标准

  • •Sulphonamide hypersensibility
  • •Propyleneglycols hypersensibility
  • •Enzyme glucose deshydrogenase deficiencies
  • •Others studies participation
  • •Tutorship or curatoship

研究组 & 干预措施

Standard dressing procedure

Other

One arm receive standard dressing procedure according to the wound

干预措施: Standard dressing procedure (Other)

Flammacerium

Active Comparator

Necrosis covering with Flammacerium 3 mm thick each day during one week then one day on two.

On each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears.

Cover Flammacerium by compress.

干预措施: Flammacerium (Other)

结局指标

主要结局

Amputation rate

时间窗: 6 months

Level of amputation

次要结局

  • Infection rate(6 months)
  • Wound size(6 months)
  • Pain during dressing (VAS)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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