Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

This is a single-blind, randomized pilot study conducted in patients with bilateral venous
stasis leg ulcers.

The aim of the study is to compare the rate of healing for venous stasis ulcers when using
the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.

The primary objective is to determine if the PICO™ NPWT system results in an increased rate
of healing when compared to standard of care for the treatment of venous stasis ulcers.

Inclusion Criteria:

- Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any
break in the skin that has either been present for longer than 6 wks or occurred in a
person with a history of venous leg ulceration).

- The ulcer is required to be venous in appearance (ie: moist, shallow, and of an
irregular shape), and judged unlikely to heal within 21 days.

- 18 years old or older

- Have an ankle brachial pressure index of at least 0.8 that was measured within the
previous 3 months.

Exclusion Criteria:

- • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).

- Patients who have a pressure index measured within the previous 3 months to be
greater than 1.20

- Patients with venous stasis ulcers greater than 17cm by 17cm.

- Gross leg edema

- Severe wound exudate

- Patients with malignancy in the wound bed or margins of the wound

- Previously confirmed and untreated osteomyelitis.

- Patients with necrotic tissue with eschar present.

- Patients with wounds that involve exposed arteries, veins, nerves, bone fragments
or sharp edges.

- Patients with wounds that requires surgical suction.