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

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