Status:
COMPLETED
Feasibility Study of a Novel Device for Chronic Wounds
Lead Sponsor:
Stanford University
Collaborating Sponsors:
3M
Conditions:
Ulcer
Wounds and Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This is an open label study
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00660049
Start Date
March 1 2008
End Date
August 1 2010
Last Update
December 13 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305