Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment
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
One arm receive standard dressing procedure according to the wound
干预措施: Standard dressing procedure (Other)
Flammacerium
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)
