Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Stanford, California 94305


Purpose:

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


Criteria:

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


NCT ID:

NCT00660049


Primary Contact:

Principal Investigator
Dr. Anne Lynn S. Chang
Stanford University


Backup Contact:

N/A


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: January 21, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.