A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 34
- 主要终点
- Change in Ulcer Area From Baseline to the End of the Treatment Period
研究概览
简要总结
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
详细描述
The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Ulcer Area From Baseline to the End of the Treatment Period
时间窗: Baseline through 12 weeks
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
时间窗: Baseline through 12 weeks
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
次要结局
- Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period(Baseline through 12 weeks)
- Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period(Baseline through 12 weeks)
- Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period(Baseline through 12 weeks)