Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Measure of the diameter of the ulcer
研究概览
简要总结
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.
To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.
To evaluate rate of amputations and recurrence at one year after complete cicatrisation
详细描述
Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.
Main criterias:
Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).
Secondary criterias:
Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Obtained informed consent
- •Leg or foot arterial or mixed ulcer older than at least 3 months
排除标准
- •No obtained informed consent
- •Possibility for surgical treatment (revascularisation)
- •Age less than 18
- •Pregnancy
- •Indication for major amputation (below /above the knee)
- •Venous ulcer
- •Ulcer with infection and / or necrosis
- •Mycotic ulcer
结局指标
主要结局
Measure of the diameter of the ulcer
时间窗: Every week
次要结局
未报告次要终点