V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds

Inclusion Criteria:

- The patient is of 18 years or older.

- Males and females - provided they are not pregnant and if of reproductive age are
using contraception.

- Patient with ulcers that:

1. Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound
tracing

2. Have been present for at least 4 weeks

3. Are confirmed to have a colony forming unit per gram of wound tissue greater than
or equal to 10 to the 5th cfu

4. Are full thicknesses through to dermal or subcutaneous tissue but not extending
to muscle or bone.

5. The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a
suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which
confirms venous disease & therefore treatment with Profore is deemed acceptable
by the clinician.

6. The patient has one or more clinical signs of infection (edema, malodor,
local/periwound erythema, spontaneous pain between dressing changes, increased
exudate, discoloration of granulation tissue, increased temperature at wound, non
progression of wound, purulent exudate and friable granulation tissue)

7. The patient is able to understand the evaluation and is willing to consent to the
evaluation.

8. Patients with a suitable wound on a different limb to any other wounds previously
eligible.

Exclusion Criteria:

1. Patients undergoing chemotherapy

2. Patients being treated with immunosuppressive drugs or corticosteroids

3. Patients with an autoimmune disease

4. Patients who have participated in an experimental drug or device study within the last
15 days

5. Patients that have been entered in this evaluation previously as an evaluable patient.