Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

Stopped early · Not applicable

Conditions studied: Lymphedema

In brief

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 therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition. The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression. This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.

Key facts

Study ID

NCT01239160

Run by

Tactile Medical

People needed

238

Starts

2010-11-02

Expected to finish

2012-06-27

Last updated by the study team

2020-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.
• 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

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• Northwestern University — Chicago, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic — Columbia, Missouri, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Carolinas Rehabilitation — Charlotte, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Greenville Hospital Systems — Greenville, South Carolina, United States
• Fletcher Allen Health Care, Inc., University of Vermont — Colchester, Vermont, United States
• Flinders Medical Center — Adelaide, Australia
• LOROS Hospice — Leicester, Leics, United Kingdom
• King's Mill Hospital — Mansfield, Nottinghamshire, United Kingdom
• University of Glasgow — Glasgow, Scotland, United Kingdom
• Abertawe Bro Morgannwg University — Swansea, West Glamorgan, United Kingdom
• Royal Derby Hospital — Derby, United Kingdom
• St Oswalds Hospice — Gosforth, United Kingdom
• Kendal Lymphology Centre — Kendal, United Kingdom
• Norfolk and Norwich University — Norwich, United Kingdom
• Queens Medical Center — Nottingham, United Kingdom
• Lymphoedema Clinic, Singleton Hospital — Swansea, United Kingdom
• St Giles Hospice — Whittington, United Kingdom

Full record on ClinicalTrials.gov

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