Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

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.

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
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