Feasibility Study of a Novel Device for Chronic Wounds

This is an open label study

Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that
is >1.5cm and <10cm at widest point

- The wound must have at least 2 cm of intact epithelium surrounding it.

- A wound such as a pressure ulcer or chronic ulcer on a location other than the lower
extremity may also be included in the study if it meets the size requirements and a
reliable seal can be achieved.

- Ulcer must not have healed for >14 days under standard treatment.

- Chronic wound with prior graft placement will be allowed in the study.

- Patient is >18 years old.

- Willing and able to sign informed consent.

Exclusion Criteria:- Active wound infection.

- 3+ or greater pitting edema of lower extremity

- History of malignancy at wound site. However, wounds that are closing by secondary
intent after surgical clearance of prior tumor will be allowed in the study.

- Thick eschar at wound base after debridement.

- Wound location is not amenable to forming an airtight seal and placement of device.

- Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid
arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or
pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's
syndrome.

- Current smoker (must have quit for >3 weeks)

- Wound with exposed bone, blood vessels, tendon

- Significant immunosuppression (as determined by the investigator and sponsor) such as
high dose prednisone

- Fasting blood sugar >200 by study personnel administered bedside fingerstick blood
glucose

- Ankle brachial index less than lower limit of normal (<0.60) as performed and
determined by licensed physician (necessary only for patients with lower extremity
wounds).

- Pregnancy

- Incapable of giving informed consent

- Inability to comply with study procedures including lack of telephone access for week
8 telephone survey