Status:
TERMINATED
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Lead Sponsor:
Tactile Medical
Conditions:
Lymphedema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and...
Detailed Description
This is a Multicentre, prospective, single (assessor) blind randomised study. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs with an advanced...
Eligibility Criteria
Inclusion
- Subjects must be ≥ 18 years old or legal age in host country.
- Subjects must have a diagnosis of primary or secondary late Stage 2 or 3 unilateral or bilateral lower extremity lymphoedema.
- At time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable.
- If subjects were treated in a clinic setting for lymphoedema (Phase 1 treatment) they must be at least 3 months post completion of their acute care.
Exclusion
- 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.
- Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.
- Diagnosis of acute thrombophlebitis (in last 2 months)
- Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower.
- Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
- Diagnosis of pulmonary edema
- Diagnosis of congestive heart failure (uncontrolled)
- Diagnosis of chronic kidney disease with a Glomerular Filtration Rate (GFR) of less than 30 mls per minute.
- Patients with poorly controlled asthma (i.e. those with severe persistent symptoms throughout the day, night time awakenings several times per week, use of a beta2 agonist inhaler several times per day and those whose normal activity is extremely limited).
- Pregnancy
- Any condition where increased venous and lymphatic return is undesirable
- Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
- Currently participating in another clinical trial
Key Trial Info
Start Date :
November 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2012
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01239160
Start Date
November 2 2010
End Date
June 27 2012
Last Update
November 6 2020
Active Locations (22)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85050
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62701
4
University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
Columbia, Missouri, United States, 65203