Last updated on February 2016

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema


Brief description of study

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.

Detailed Study 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 PCD compared to a simple PCD in patients with lower limb lymphoedema. The main outcome is the percentage volume reduction of the affected limb at end of treatment compared to baseline. Secondary objectives of the study are Assessment of safety Quality of life Health economic parameters In total 262 patients with leg lymphoedema will be enrolled into the study. Patients eligible for the study are those who suffer from late stage II and stage III according to the International Society of Lymphology lymphoedema staging. Lymphoedematous legs can be of primary or secondary origin and uni or bilaterally affected. Medical history will be taken at baseline. Patients will be taught how to use the device they have been randomised to. Visits will then take place at weeks 1,4,8,12 and 24 weeks. The device will be used for up to 60 minutes each day on the trial limb. At each visit sequential circumferences of the affected and unaffected limbs will be measured with a tape measure. All adverse events will be documented. At beginning and end of study quality of life questionnaires and health economic information will be completed by the patients. At the Derby site assessment of tissue quality will be made using ultrasound and moisture meter to assess tissue fluid.

Clinical Study Identifier: NCT01239160

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Christine J Moffatt, RGN PhD

Hope Research Institute
Phoenix, AZ United States
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Christine J Moffatt, RGN PhD

Northwestern University
Chicago, IL United States
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Christine J Moffatt, RGN PhD

Prairie Education & Research Cooperative
Springfield, IL United States
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Christine J Moffatt, RGN PhD

University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic
Columbia, MO United States
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Christine J Moffatt, RGN PhD

Stony Brook University Medical Center
Stony Brook, NY United States
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Christine J Moffatt, RGN PhD

Carolinas Rehabilitation
Charlotte, NC United States
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Christine J Moffatt, RGN PhD

Ohio State University Medical Center
Columbus, OH United States
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Christine J Moffatt, RGN PhD

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Christine J Moffatt, RGN PhD

Greenville Hospital Systems
Greenville, SC United States
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Christine J Moffatt, RGN PhD

Fletcher Allen Health Care, Inc., University of Vermont
Colchester, VT United States
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Neil Pillar, PhD

Flinders Medical Center
Adelaide, Australia
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Christine J Moffatt, RGN PhD

LOROS Hospice
Leicester, United Kingdom
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Christine J Moffatt, RGN PhD

University of Glasgow
Glasgow, United Kingdom
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Christine Moffatt, RN PhD

Royal Derby Hospital
Derby, United Kingdom
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Christine J Moffatt, RGN PhD

St Oswalds Hospice
Gosforth, United Kingdom
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Christine J Moffatt, RGN PhD

Kendal Lymphology Centre
Kendal, United Kingdom
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Christine J Moffatt, RGN PhD

Lymphoedema Clinic, Singleton Hospital
Swansea, United Kingdom
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Christine J Moffatt, RGN PhD

St Giles Hospice
Whittington, United Kingdom
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