Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Therapy adherence tracking
研究概览
简要总结
An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined:
- Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool.
- Arm volume maintenance or improvement as measured prior to and after 28 days of device use.
- Safety as assessed by reported adverse events
- Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and
- Adherence to therapy as measured with a smart phone app.
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
- •Males and females ≥ 18 years of age
- •Willing to sign the informed consent and deemed capable of following the study protocol
- •Subjects must have a diagnosis of primary or secondary unilateral or bilateral upper extremity edema
排除标准
- •Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
- •Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
- •Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
- •Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
- •Diagnosis of Acute infection (in the last two weeks)
- •Diagnosis of acute thrombophlebitis (in last 2 months)
- •Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower
- •Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
- •Diagnosis of pulmonary edema
- •Diagnosis of congestive heart failure (uncontrolled)
- •Diagnosis of chronic kidney disease
- •Diagnosis of epilepsy
- •Patients 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
结局指标
主要结局
Therapy adherence tracking
时间窗: 28 days
Therapy adherence tracked via the mobile app linked to the Dayspring™ device.
Arm Volume Maintenance or Improvement
时间窗: 28 days
Limb volume measurement was performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements were taken for both upper extremities. If both extremities exhibited edema, a study arm was designated for treatment. Measurements were taken by the same investigator throughout the study. Volume was calculated based on cylindrical segment analysis.
LYMQOL (LYMphedema Quality of Life)
时间窗: 28 days
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.
Safety/AEs
时间窗: 28 days
As assessed by reported adverse events
次要结局
- Patient survey(28 days)