Feasibility Study of a Novel Device for Chronic Wounds

This is an interventional treatment trial for Ulcer Read More

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