Expired Study
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Stanford, California 94305


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.

Study summary:

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



Primary Contact:

Principal Investigator
Dr. Anne Lynn S. Chang
Stanford University

Backup Contact:


Location Contact:

Stanford, California 94305
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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