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

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 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.