An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds, Covered With Devitalised Tissue, During Six Weeks Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RLS Global
- 入组人数
- 59
- 试验地点
- 17
- 主要终点
- The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.
研究概览
简要总结
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
详细描述
Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.
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
- •Full skin ulcer at lower leg covered with devitalised tissue ≥50%
- •Candidate for cleansing, debridement/desloughing
- •Wound area ≥2 cm²
- •Male or female, 18 years of age and above
- •Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent
- •Able and willing to follow the Protocol requirements
排除标准
- •Clinical signs of system progression infection with or without ostemyelitis
- •Wound located where treatment is not possible
- •Subjects not suitable for the investigation according to the investigator's judgment
- •Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- •Known allergy/hypersensitivity to any of the components of the investigational device
- •Pregnant or breast feeding women
- •Other significant medical condition that the investigator determines could interfere with compliance or study assessments
- •Subjects with wounds of duration less than one month
- •Wound area greater than approximately 60 cm²
结局指标
主要结局
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.
时间窗: 6 weeks
The debriding effect of ChloraSolv® will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor.
次要结局
- The secondary objectives are to evaluate change of devitalised tissue, change in wound area, pain during treatment, condition of the wound, need for sharp debridement and overall evaluation of the product and safety parameters.(12 weeks)