Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
研究概览
简要总结
the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy
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
- Single (Participant)
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
- •• Patients over 18 who have given written informed consent
- •Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions
- •Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
- •Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
- •Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
- •Patients who are available for monitoring for at least 10 weeks
排除标准
- •• Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment
- •Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
- •Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
- •Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
- •Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
- •Patients with unbalanced diabetes at the discretion of the investigator
- •Patients with a known allergy to one of the components in Biatain Argent® or Biatain
- •Patients who are already taking part in another clinical study
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
1
Biatain Ag dressing
干预措施: Biatain Ag (Device)
2
Biatain dressing
干预措施: Biatain (Device)
结局指标
主要结局
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
时间窗: Day 0 to Day 42
The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght \*Width \* pi \[3.142\] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.
次要结局
- Total Number of Adverse Events(Day 0 to Day 70)
- Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline(Day 0 to Day 70)