Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers

Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using
standard of care multi-layer bandaging before receiving 4 weeks of treatment using a
pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation,
complete symptom and quality of life questionnaires.

Inclusion Criteria:

- Subject must be ≥ 18 years of age or legal age at the time of enrollment.

- Chronic venous insufficiency confirmed by ultrasound within previous 12 months.

- Active ulceration (CEAP classification of C6)

- Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with
conservative treatment.

- Ulcer size ≥ 2cm2 ≤ 50cm2

- Leg circumferences within the following range:Ankle - 12 to 44cm;Calf - 22 to 60cm;
Below knee - 22 to 68cm

Exclusion Criteria:

- Target ulcer or any other ulcer on the study limb involves exposure of tendon,
muscle, or bone.

- Greater than 3 separate full thickness ulcers on the study limb

- Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica
diabeticorum, pyoderma, malignancy).

- Treatment of the target ulcer with living cellular therapy within 30 days of the time
of enrollment.

- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the
last 3 months.

- Either the dorsalis pedis (DP) or posterior tibial (PT) systolic pressure < 80mmHg
for diabetic patients or < 60mmHg for non-diabetic patients on study limb or
transcutaneous partial pressure oxygen (Tcp02) ≤ 30mmHg or great toe systolic
pressure ≤ 40mmHg.

- Acute thrombophlebitis.

- History of pulmonary edema or decompensated congestive heart failure.

- Currently has an active infection of the skin such as cellulitis requiring
antibiotics.

- History of cancer within the last 5 years with the exception of treated non-melanoma
skin cancer or cervical carcinoma in situ.

- Poorly controlled diabetes with an HbA1c value of >12%.

- Changes to medications that affect edema within the last 30 days

- Need for current and ongoing therapy with corticosteroids (exception for continued
low dose usage) or cytotoxic drugs or the current use of Daflon 500.

- Currently pregnant or trying to become pregnant.

- Inability or unwillingness to participate in all aspects of study protocol.

- Currently participating in another clinical trial.