Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Limb Volume (% Change)
研究概览
简要总结
Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.
详细描述
This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects must be ≥ 18 years old
- •Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema
- •Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime)
- •Subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test"
- •Must be able to attend all required in-clinic treatment visits
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 infection or inflammation
- •Active thrombophlebitis (within the last 2 months)
- •History of pulmonary embolism (within the last 2 months)
- •Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of > 2 second in the deep system or any history of deep vein thrombosis (DVT)
- •History of pulmonary edema
- •History of congestive heart failure
- •History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute
- •Poorly controlled asthma
- •Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia)
- •Presence of an open wound or ulcer of any etiology
- •Diagnosis of lipoedema and lipolymphoedema
- •Currently using an in-home pneumatic compression device
- •Metal implant(s) that would interfere with bioimpedance equipment
- •Pacemaker or other implanted electronic device(s)
- •Unable or unwilling to remove bandaging from treatment regimen while participating in the study
- •Any condition where increased venous and lymphatic return is undesirable
- •Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent
- •Currently participating in another clinical trial
- •Currently using diuretics
- •BMI > 40
结局指标
主要结局
Limb Volume (% Change)
时间窗: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Limb Volume (ml)
时间窗: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Change in Skin Tone
时间窗: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone.
Patient Reported Outcomes - MYMOP
时间窗: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Changes in patient-determined symptoms\* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). \*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing
次要结局
- Incidence of Complications(Change baseline to final day (day 12 for Group A and day 5 for Groups B and C))
- Cellular Fluid Changes (Ohms)(Change after initial treatment on day 1 and change baseline to end of day 5 for all groups)
- Activity Level(Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C))
- Cellular Fluid Changes (% Change)(Change after initial treatment on day 1 and change baseline to end of day 5 for all groups)