The purpose of this study is to evaluate the feasibility and usability of a new portable and
compact wound dressing device for the treatment of small chronic skin 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
- 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
- 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
- Incapable of giving informed consent
- Inability to comply with study procedures including lack of telephone access for week
8 telephone survey