Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
Stopped early
Conditions studied: Lymphedema
In brief
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.
Key facts
- Study ID
- NCT02661646
- Run by
- Tactile Medical
- People needed
- 249
- Starts
- 2015-12-01
- Expected to finish
- 2023-02-01
- Last updated by the study team
- 2023-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- VA Maryland Healthcare System — Baltimore, Maryland, United States
- VA New Jersey Health Care System (VANJHCS) — East Orange, New Jersey, United States
- VA NY Harbor Healthcare System - Brooklyn — Brooklyn, New York, United States
- VA Western New York Healthcare System — Buffalo, New York, United States
- VA NY Harbor Healthcare System - St. Albans — Jamaica, New York, United States
- VA NY Harbor Healthcare System - Manhattan — New York, New York, United States
Full record on ClinicalTrials.gov
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