Acute and Chronic WoundsNCT01113658
Clinical Evaluation of the SNaP Wound Care System
A study testing SNaP Wound Care System in people with Acute and Chronic Wounds and Pressure Ulcers, run by 3M at 2 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds
- What is being tested?
- SNaP Wound Care System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Wound < 10 cm in greatest diameter
- Patient >18 years of age
- Willing and able to sign informed consent
Who cannot join
- Patients with wound-related cellulitis
- Patients with thick eschar at wound base post debridement
- Patients with wounds located in an area not amenable to forming an air- tight seal
- Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
- Patient has untreated osteomyelitis
- Patient is allergic to wound care products
Show all 9Show fewer
- Patient wounds with exposed blood vessels not suitable for negative pressure therapy
- Pregnant or pregnancy-suspected patients
- Subject actively participating in other clinical trials that conflict with the current study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Center for Advanced Wound Care
Daly City, California, 94015
The SF Center For Advanced Wound Care At
Daly City, California, 94015
About this study
Official title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers, Venous Stasis Ulcers
- Being tested
- SNaP Wound Care System
- Keywords
- negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System
- Medical subject headings
- Pressure Ulcer, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNaP Wound Care SystemDevice
Also called Spiracur SNaP Wound Care System, SNaP, The SNaP System
The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts.
The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician.
| Study group | Role | What they receive |
|---|---|---|
| SNaP | Experimental | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System Receives: Device: SNaP Wound Care System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of complaints about device use and operation
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startMar 2010 (estimated)
- Primary completionApr 2014 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic WoundsStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristine K Nemes, DPM, Principal investigator, Seton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113658
- Sponsor's protocol ID
- SNaP-113009
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2010
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
- ClinicalTrials.gov ID
- NCT01113658
- Acronym / sponsor ID
- SNaP-113009
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers, Venous Stasis Ulcers
- Keywords
- negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Mar 2010 (estimated)
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
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 assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNaP | Experimental | Device: SNaP Wound Care SystemSNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Wound < 10 cm in greatest diameter
- Patient >18 years of age
- Willing and able to sign informed consent
Key exclusion criteria (9 listed)
- Patients with wound-related cellulitis
- Patients with thick eschar at wound base post debridement
- Patients with wounds located in an area not amenable to forming an air- tight seal
- Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
- Patient has untreated osteomyelitis
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 Wound Care SystemAlso: Spiracur SNaP Wound Care System, SNaP, The SNaP SystemThe intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts. The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician. | Device | SNaP |
Primary outcome
Frequency of complaints about device use and operation
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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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.
Kristine K Nemes, DPM principal investigator
Seton Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNaP Wound Care System in people with Acute and Chronic Wounds and Pressure Ulcers, run by 3M at 2 sites 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of complaints about device use and operation (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.