Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events.
研究概览
简要总结
Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes.
Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes aged over 18 years
- •people with skin ulcers of the lower limbs for at least 3 months
排除标准
- •Lesion with a diameter larger than 12 cm ²
- •injury over 2 years of evolution; injury infected
- •neoplastic lesions in activity
- •poorly controlled diabetes mellitus
- •HAS poorly controlled
- •signs of ischemia in the limb
- •not offset any disease
- •allergic to components of formula
- •urticaria
- •pregnancy
- •breastfeeding
- •emotional disturbance
结局指标
主要结局
Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events.
时间窗: healing
次要结局
未报告次要终点