VLU Non-inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-layer Bandaging

Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using
standard of care multi-layer bandaging before being randomly assigned to either treatment
using a dual action pneumatic compression device or multi-layer bandaging for up to 16 weeks.
Participants will be seen in clinic for treatment, 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 or
prior to randomization.

- Must have at least one of the following within the past six (6) months: Dorsalis Pedis
(DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic
patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic
patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial
pressure oxygen (TcP02) > 30mmHg; Great toe systolic pressure > 40mmHg

- Active ulceration (CEAP classification of C6)

- Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.

- Ulcer size ≥ 2cm2 ≤ 50cm2

- Three or fewer separate full thickness ulcers on the study limb.

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

- Must be able and willing to provide informed consent prior to study participation.

Exclusion Criteria:

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

- 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 projected randomization.

- Endovenous ablation or other venous surgery within one week of enrollment

- History of skin sensitivity to any of the components of AT, multi-layer bandages or
compression garments.

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

- Acute thrombophlebitis within the last six (6) weeks.

- History of pulmonary edema or decompensated congestive heart failure within six (6)
weeks of screening.

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

- History of target limb cancer within the last two years with the exception of treated
non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for
neoplasia.

- Active cancer receiving chemotherapy and/or radiation therapy.

- Poorly controlled diabetes with an HbA1c value of > 12% within the past three (3)
months.

- Changes to medications that affect edema within the last 30 days prior to enrollment
(e.g. diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone,
cox-1 inhibitors, pregabalin, and gabapentin, diltiazem or fluctuating doses of
systemic steroids).

- Use of systemic corticosteroids requiring daily administration at doses greater than
5mg of Prednisone per day or equivalent for greater than two weeks.

- Currently pregnant or trying to become pregnant.

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

- Exhibit any condition which, according to the Investigator, justifies the subject's
exclusion from the study, such as a medical condition where an increase in venous or
lymphatic return is undesirable.

- Currently participating in another clinical trial.

Additional Exclusion Criteria after two week run-in:

- If ulcer area has decreased by greater than 30% compared to baseline area.

- Ulcers measuring less than 1.5cm² after the run in will be excluded.

- Any ulcer appearing to have evidence of infection.

- Ulcers increasing in size greater than 50% after run in also excluded.

- If the sum of the ulcer areas on the study limb is > 50cm2 the subject is excluded.