Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
2021年6月29日 更新者：Tactile Medical
Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Derby、英国、DE22 3NE
- Royal Derby Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：pneumatic compression - 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
|
Pneumatic compression treatment once per day (1 hour)
其他名称：
|
|
实验性的：pneumatic compression - 2 hours per day
Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
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pneumatic compression treatment twice per day in the AM & PM (2 hours)
其他名称：
|
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实验性的：pneumatic compression - 4 hours per day
Pneumatic compression device - 5 consecutive days undergoing treatment twice per day consisting of 2 consecutive 1 hour treatments in the am and the pm (4 hours total)
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pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Limb Volume (ml)
大体时间：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.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
|
Limb Volume (% Change)
大体时间：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.
|
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
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Change in Skin Tone
大体时间：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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.
|
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
|
Patient Reported Outcomes - MYMOP
大体时间：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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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 |
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cellular Fluid Changes (Ohms)
大体时间：Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
|
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
|
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Cellular Fluid Changes (% Change)
大体时间：Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
|
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
|
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Incidence of Complications
大体时间：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
Number of complications experienced.
Incidence based on clinician assessment.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
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Activity Level
大体时间：Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
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Change in number of steps as accumulated each day monitored through use of a pedometer.
A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
|
Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Skin Thickness
大体时间：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
Change in skin thickness measured by ultrasound.
Ultrasound measures were collected at 5 anatomical locations.
A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).
|
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
|
Change in Local Tissue Water (LTW)
大体时间：Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD).
MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50).
A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).
|
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Vaughan Keeley, PhD, FRCP、Royal Derby Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月11日
初级完成 (实际的)
2019年3月31日
研究完成 (实际的)
2019年6月30日
研究注册日期
首次提交
2014年1月7日
首先提交符合 QC 标准的
2014年1月7日
首次发布 (估计)
2014年1月9日
研究记录更新
最后更新发布 (实际的)
2021年7月20日
上次提交的符合 QC 标准的更新
2021年6月29日
最后验证
2021年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 4010 FlexDose
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