NCT01111695已完成2 期
Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Granulation and /or epithelial tissue progression
研究概览
简要总结
In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data.
The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.
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
- •Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and
- •Written informed consent
排除标准
- •Refuse to give written informed consent.
- •Patient suffering from mental disorder that may interfere with the treatment.
- •Known allergy or intolerance to any of the products used in the formulation.
- •Having received systemic antibiotics within 7 days of starting treatment with honey based formulation.
- •Arterial insufficiency stage IV of the lower limbs.
结局指标
主要结局
Granulation and /or epithelial tissue progression
时间窗: 8 weeks
Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
次要结局
- Tolerance(8 weeks)
研究者
研究点 (1)
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