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Feasibility Study of a Novel Device for Chronic Wounds
This study is currently recruiting participants
Study NCT00660049. Last updated on January 14, 2009.
Information provided by Stanford University
| 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. |
| Study Type |
Interventional |
| Study Design |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Primary Outcome Measure |
Ease of use for patients and clinicians |
| Secondary Outcome Measure |
Suggestions for improvement |
| Condition |
Ulcer,
n Ulcer,
Wounds and Injuries |
| Intervention |
Device: SNaP Advanced Wound Care System |
| Recruitment Information |
| Recruitment Status |
Recruiting |
| Enrollment |
30 |
| Start Date |
March 2008 |
| Eligibility Criteria |
Inclusion Criteria: Venous stasis ulcer or other chronic wound on the lower extremity that is <6 cm in widest diameter.
- 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.
- Chronic wound with prior graft placement will be allowed in the study.
- Patient is >18 years old and <90 years old.
- Willing and able to sign informed consent.
 Exclusion Criteria:- Active wound infection.
- 2+ 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, 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
- Ankle brachial index less than lower limit of normal (<0.60)
- Pregnancy
- Incapable of giving informed consent
- Inability to comply with study procedures including lack of telephone access
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| Gender |
Both |
| Ages |
18 Years to 90 Years |
| Contact |
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| Location Countries |
United States |
| Administrative Information |
| NCT ID |
NCT00660049 |
| Organization ID |
SU-02252008-1026 |
| Secondary IDs |
IRB Protocol #: 11074 |
| Study Sponsor |
Stanford University |
| Collaborators |
Spiracur, Inc. |
| Investigators |
Principal Investigator:
Dr. Anne Lynn S. Chang
Stanford University |
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| Information Provided By |
Stanford University |
| Verification Date |
January 2009 |
| First Received Date |
April 4, 2008 |
| Last Updated Date |
January 14, 2009 |
Source
Added February 17, 2009
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