UlcerNCT00660049
Feasibility Study of a Novel Device for Chronic Wounds
A study testing SNaP Advanced Wound Care System and SNaP in people with Ulcer and Wounds and Injuries, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Wounds and Injuries
- What is being tested?
- SNaP Advanced Wound Care System and SNaP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the detailed description
This is an open label study
- Conditions
- Ulcer, Wounds and Injuries
- Being tested
- SNaP Advanced Wound Care System, SNaP
- Medical subject headings
- Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNaP Advanced Wound Care SystemDevice
Also called SNaP device (SmartNegative Pressure device)
Application of negative pressure device daily per instructions
SNaPOther
Also called SNaP device
Daily use
SNaPOther
Daily application per protocol
| Study group | Role | What they receive |
|---|---|---|
| SNaP application | Experimental | This is an "open label" pilot study of SNaP Advanced Wound Care System Receives: Device: SNaP Advanced Wound Care System; Other: SNaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use for Patients
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.
Measured: Baseline up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UlcerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Anne Chang, Stanford University
- Investigators
- Dr. Anne Lynn S. Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660049
- Sponsor's protocol ID
- SU-02252008-1026
- Other IDs
- IRB Protocol #: 11074
- Status last verified
- Nov 2017
- First submitted
- 4 Apr 2008
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No sharing
Publications
Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, Lorenz HP, Chang AL. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010 Sep;22(9):230-6.
PubMed 25901554
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Novel Device for Chronic Wounds
- ClinicalTrials.gov ID
- NCT00660049
- Acronym / sponsor ID
- SU-02252008-1026
- Conditions
- Ulcer, Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Posted 20 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNaP application | Experimental | Device: SNaP Advanced Wound Care System, Other: SNaPThis is an "open label" pilot study of SNaP Advanced Wound Care System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNaP Advanced Wound Care SystemAlso: SNaP device (SmartNegative Pressure device)Application of negative pressure device daily per instructions | Device | SNaP application |
| SNaPAlso: SNaP deviceDaily use | Other | SNaP application |
| SNaPDaily application per protocol | Other | SNaP application |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25901554Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, Lorenz HP, Chang AL. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010 Sep;22(9):230-6.
- Individual participant dataSharing planned: No. No sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Anne Lynn S. Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNaP Advanced Wound Care System and SNaP in people with Ulcer and Wounds and Injuries, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Use for Patients (time frame: Baseline up to 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.