NCT02045199已完成不适用
Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 20
- 主要终点
- Complete healing of target fissure on the heel
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus with neuropathy,
- •Cracked open heel with at least one fissure Grade 2,
排除标准
- •Open wound, skin infection, haemorrhagic crack on feet,
- •Major static disorder ,
- •Ulceration and history of ulceration,
- •Active haemorrhagic crack,
- •Hyperkeratotic disease
- •Diabetic arteriopathy,
结局指标
主要结局
Complete healing of target fissure on the heel
时间窗: Day 28
Comparison of the two treatment groups (verum versus placebo)
次要结局
未报告次要终点
研究者
研究点 (20)
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