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
- 17
- 主要终点
- Percentage 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
- •Provide informed consent
- •Age ≥ 18 years and of either sex
- •Willing to comply with protocol instructions, including allowing all study assessments
- •Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
- •Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
- •Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
- •Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
- •Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
- •Acceptable state of health and nutrition
排除标准
- •Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
- •Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
- •Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
- •Clinical evidence of target ulcer infection
- •Current systemic therapy with cytotoxic drugs.
- •Current therapy with chronic (> 10 days) oral corticosteroids.
- •Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
- •Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
研究组 & 干预措施
PICO System
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
干预措施: PICO System (Device)
tNPWT System
Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.
干预措施: tNPWT System (Device)
结局指标
主要结局
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.
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.
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)