Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:November 2010
End Date:July 2020
Contact:Christine J Moffatt, RGN PhD
Phone:01332 340131

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At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)

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.

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

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

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.

Inclusion Criteria:

- 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 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.

- 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

- 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
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Columbus, OH
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Greenville, South Carolina 29605
Greenville, SC
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Phoenix, Arizona 85050
Phoenix, AZ
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Pittsburgh, PA
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
Stony Brook, NY
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