Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Antimicrobial efficacy of octenisept® compared to placebo
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.
详细描述
Randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.
Primary Objectives: Antimicrobial efficacy of octenisept® compared to placebo. Secondary Objectives: Subjective tolerance of octenisept®, evaluation of wound parameters.
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
- 否
入选标准
- •Male and female patients of at least 18 years at the time of consent
- •Patients with a venous leg ulcer (Ulcus cruris)
- •Patients with a chronic leg ulcer
- •Females of childbearing potential who are willing to comply with any applicable contraceptive requirements of the protocol
- •Negative pregnancy test
- •Satisfactory medical assessment
- •Ability to provide written informed consent
- •Signed declaration of consent
- •Willingness to co-operate
排除标准
- •Pregnant or lactating women and women not using contraception
- •Known history of alcohol or drug abuse
- •Use of any antibiotic medication within the last 7 days prior to the first dose
- •Patients with serious concomitant disease
- •Patients with a coagulation disorder
- •Known history of allergic reactions attributed to octenisept® or one of its compounds
- •Participation in another clinical trial within the last 30 days before randomization
- •Concomitant treatment with other preparations that interfere with the trial preparation or the disease
- •Absence of declaration of consent
- •Doubt about willingness to co-operate
- •Non-fulfilment of the inclusion criteria
研究组 & 干预措施
verum
干预措施: octenisept® (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Antimicrobial efficacy of octenisept® compared to placebo
时间窗: 2 weeks after baseline
Decrease of bacterial load after 2 weeks of treatment
次要结局
- Subjective tolerance of octenisept®(2 weeks after baseline)
- Evaluation of wound parameters(2 weeks after baseline)