Feasibility Study of a Novel Device for Chronic Wounds
November 15, 2017 updated by: Anne Chang, Stanford University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open label study
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SNaP application
This is an "open label" pilot study of SNaP Advanced Wound Care System
|
Application of negative pressure device daily per instructions
Other Names:
Daily use
Other Names:
Daily application per protocol
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of Use for Patients
Time Frame: Baseline up to 31 days
|
Participants were given instructions to use the SNaP device home.
Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again.
Numbers responding positively to each question are presented.
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Baseline up to 31 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Anne Lynn S. Chang, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
April 4, 2008
First Submitted That Met QC Criteria
April 15, 2008
First Posted (Estimate)
April 17, 2008
Study Record Updates
Last Update Posted (Actual)
December 13, 2017
Last Update Submitted That Met QC Criteria
November 15, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-02252008-1026
- IRB Protocol #: 11074 (Other Identifier: Stanford University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No sharing
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.