Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 249
- 试验地点
- 6
- 主要终点
- Quality of life changes: Questionnaires
研究概览
简要总结
Assessment of quality of life and symptoms changes in primary or secondary, unilateral or bilateral lower extremity lymphedema patients using an advanced pneumatic compression system.
详细描述
Post-market, on label, multi-center, single arm, observational clinical trial of a prospective cohort of 300 subjects with primary or secondary, unilateral or bilateral, lower extremity lymphedema in the United States. All subjects will receive pneumatic compression treatment for 52 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 or older
- •Diagnosis of primary or secondary, unilateral or bilateral, lower extremity lymphedema
- •Ability and willingness to participate in all aspects of the study including following prescribed care
- •Ability to provide informed consent
- •Must have a prescription for the Flexitouch (Flexitouch system or Flexitouch Plus)
排除标准
- •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.
- •Active skin or limb infection/inflammatory disease (acute cellulitis, or other uncontrolled skin or untreated inflammatory skin disease)
- •Acute thrombophlebitis (in last 2 months)
- •Pulmonary embolism within the previous 6 months
- •Deep Vein Thrombosis (DVT) within the previous 3 months
- •Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
- •Pulmonary edema
- •Heart failure (acute pulmonary edema, decompensated acute heart failure)
- •Patients with poorly controlled asthma
- •Previous use of the study pneumatic compression device (PCD)
- •Currently using multi-layer bandaging (MLB) unless bandages can be removed for limb circumference measurements
- •Pregnant women or women of childbearing potential not on contraception
- •Any condition where increased venous and lymphatic return is undesirable
- •Currently participating in another medical device or drug clinical trial
- •Signs of noncompliance at the week 4 visit including: using the device less than 3 times per week and/or not attending the scheduled visit.
结局指标
主要结局
Quality of life changes: Questionnaires
时间窗: 12 weeks
Questionnaires to assess quality of life changes after 12 weeks of treatment
Number of lymphedema and venous related healthcare visits
时间窗: 52 weeks
Comparison of the number of lymphedema and venous related health care visits the year preceding treatment and the during the 52 weeks while receiving treatment (or until study exit)
Lymphedema symptom changes
时间窗: 12 weeks
Questionnaires \[Lymphedema Quality of Life Tool (LYMQOL)\] to assess lymphedema. symptom changes after 12 weeks of treatment. LYMQOL includes sub-scores for Function (range 8-32), Appearance (range 7-28), Symptoms (range 5-20), and Mood (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.
次要结局
- Limb circumference changes after 12 weeks and 52 weeks of treatment(12 weeks and 52 weeks)
- Assessment of skin changes after 12 weeks and 52 weeks of treatment(12 weeks and 52 weeks)
- Lymphedema staging changes after 12 weeks and 52 weeks of treatment(12 weeks and 52 weeks)
- Fibrosis grading changes after 12 weeks and 52 weeks of treatment(12 weeks and 52 weeks)
- Quality of life changes: Questionnaires(24 weeks and 52 weeks)