Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compre… (NCT02661646) | Clinical Trial Compass
TerminatedNot Applicable
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
Stopped: Due to slow enrollment during COVID
United States249 participantsStarted 2015-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
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 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life changes: Questionnaires
Timeframe: 12 weeks
2
Lymphedema symptom changes
Timeframe: 12 weeks
3
Number of lymphedema and venous related healthcare visits