An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mobility (daily steps using a pedometer)
研究概览
简要总结
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
详细描述
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years of age
- •Capable and willing to sign the informed consent and deemed capable of following the study protocol
- •Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
- •Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
排除标准
- •Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
- •Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
- •Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
- •Non-ambulatory individuals
- •Female: BMI > 34 (5'4", 200 lbs.)
- •Male: BMI > 34 (5'9", 230 lbs.)
- •(Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
- •Diagnosis of lipedema
- •Diagnosis of active or recurrent cancer (< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
- •Diagnosis of acute infection (in the last four weeks)
- •Diagnosis of active/open wound/ulcer
- •Diagnosis of acute thrombophlebitis (in last 2 months)
- •Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
- •Diagnosis of pulmonary edema
- •Diagnosis of congestive heart failure (uncontrolled/uncompensated)
- •Diagnosis of chronic kidney disease with acute renal failure
- •Diagnosis of epilepsy
- •Subjects with poorly controlled asthma
- •Any condition where increased venous and lymphatic return is undesirable
- •Women who are pregnant, planning a pregnancy or nursing at study entry
- •Participation in any clinical trial of an investigational substance or device during the past 30 days
研究组 & 干预措施
Dayspring, Non-Pneumatic Active Compression Device (NPCD)
The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
干预措施: Dayspring (Device)
结局指标
主要结局
Mobility (daily steps using a pedometer)
时间窗: 6 months
Mobility (daily steps using a pedometer)
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
时间窗: 6 months
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Lymphedema Overall Quality of Life and Patient Survey
时间窗: 6 months
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6
Venous Clinical Severity Score (VCSS)
时间窗: 180 days
Venous Clinical Severity Score (VCSS)
次要结局
- Lower extremity edema response (limb girth reduction)(6 months)
- Venous Clinical Severity Score (VCSS)(6 months)
- LE Functional Index (LEFI)(6 months)
- Safety/Adverse Events(6 months)