A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.
试验速览
- 阶段
- 3 期
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of ulcerated area re-epithelialised
研究概览
简要总结
Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.
The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 60
- •REBD clinically evident with immunohistological confirmation and / or genetic
- •REBD with at least two chronic ulcers (> 3 months) comparable
- •Signing the informed consent of the patient and / or (children) of parents holding parental authority
- •Affiliation to a social security scheme (beneficiary or legal)
排除标准
- •Epidermoid carcinoma on the target or chronic ulcers
- •Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
- •Skin bacterial superinfection clinically overt requiring oral antibiotics
- •Herpes simplex virus superinfection
- •major evolutionary and malnutrition defined as a BMI <12 or more than 2 variant between screening and randomization OR a serum albumin <20 g / l or more ranging from 5 g / l between screening and randomization
- •major and progressive anemia defined by a Hb <6 g / liter or variant more than 4 g / l between screening and randomization
- •Life expectancy estimated at less than 3 months
- •Pregnancy
- •Inability to understand or observance of the rules of protocol
- •Participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in Mabul
结局指标
主要结局
Percentage of ulcerated area re-epithelialised
时间窗: at 12 weeks from the start of treatment
次要结局
未报告次要终点