UlcersNCT00951080
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
A study testing Traditional NPWT System and SNaP Wound Care System in people with Ulcers and Wounds, run by 3M at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Traditional NPWT System and SNaP Wound Care System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2009to Mar 2011
- 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
- Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
- Subject has wound present for >30 days despite appropriate wound care
- Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2)
- Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
- Subject is able to understand and provide written consent
- Subject able to understand and provide written consent
- Male or non-pregnant female willing to have urine pregnancy test
Who cannot join
- Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
- Subject has Untreated Osteomyelitis
- Subject has Allergy to Wound Care Products used in the study
- Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
- Subject has Active Charcot Arthropathy of the Foot
- Subject has study wound location on toes or plantar surface of foot
Show all 14Show fewer
- Subject has uncontrolled hyperglycemia (HbA1C >12%)
- Subject has end stage renal disease requiring dialysis
- Subject is undergoing active chemotherapy treatment that inhibits wound healing
- Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment
- Subject has a >30% wound surface area reduction in size at 1 week after screening visit
- Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
- Subject is unwilling or unable to comply with protocol requirements
- Subject is pregnant
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bethesda Health City Wound Care Center
Boynton Beach, Florida, 33437
Center for Clinical Research, Inc.
Castro Valley, California, 94546
University of North Carolina
Chapel Hill, North Carolina, 27599
The Christ Hospital, Wound Healing Center
Cincinnati, Ohio, 45219
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016
Jay Mukker, DPM Inc.
Fresno, California, 93726
Wound Care on Wheels, LLC
Jacksonville, Florida, 32216
Osceola Regional Medical Center
Kissimmee, Florida, 34741
LA Cardiovascular & Limb Salvage Center
Lafayette, Louisiana, 70506
Hope Research Institute
Phoenix, Arizona, 85050
Palomar Pomerado Health Wound Care Center
Poway, California, 92078
O'Connor Wound Care Clinic
San Jose, California, 95128
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, 85724
Southwest Washington Medical Center Wound Healing Center
Vancouver, Washington, 98664
John Muir Wound Care Center
Walnut Creek, California, 94598
New Bridge Medical Research Corporation
Warren, Pennsylvania, 16365
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
Read the detailed description
This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.
- Being tested
- Traditional NPWT System, SNaP Wound Care System
- Keywords
- ulcer, venous, diabetic, wounds and injuries
- 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.
Traditional NPWT SystemDevice
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
SNaP Wound Care SystemDevice
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
| Study group | Role | What they receive |
|---|---|---|
| SNaP Wound Care System | Experimental | Not described Receives: Device: SNaP Wound Care System |
| Traditional NPWT System | Active comparator | Not described Receives: Device: Traditional NPWT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Wound Area
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2011
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 UlcersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, DPM, Ph.D., Principal investigator, Southern Arizona Limb Salvage Alliance (SALSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951080
- Sponsor's protocol ID
- SNP041609
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2009
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011 Mar-Apr;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.
PubMed 21362084
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
- Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
- ClinicalTrials.gov ID
- NCT00951080
- Acronym / sponsor ID
- SNP041609
- Keywords
- ulcer, venous, diabetic, wounds and injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 19 Oct 2020
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 a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
Detailed description
This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNaP Wound Care System | Experimental | Device: SNaP Wound Care System |
| Traditional NPWT System | Active comparator | Device: Traditional NPWT System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
- Subject has wound present for >30 days despite appropriate wound care
- Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2)
- Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
- Subject is able to understand and provide written consent
Key exclusion criteria (14 listed)
- Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
- Subject has Untreated Osteomyelitis
- Subject has Allergy to Wound Care Products used in the study
- Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
- Subject has Active Charcot Arthropathy of the Foot
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 |
|---|---|---|
| Traditional NPWT SystemStandard wound dressing applications followed by negative pressure system application per manufacturer recommendations. | Device | Traditional NPWT System |
| SNaP Wound Care SystemWound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | Device | SNaP Wound Care System |
Primary outcome
Percent Change in Wound Area
Time frame: Baseline and 16 weeks
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21362084Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011 Mar-Apr;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.
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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.
David G Armstrong, DPM, Ph.D. principal investigator
Southern Arizona Limb Salvage Alliance (SALSA)
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional NPWT System and SNaP Wound Care System in people with Ulcers and Wounds, run by 3M at 17 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 7 inclusion and 14 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 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 17 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). 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?
Percent Change in Wound Area (time frame: Baseline and 16 weeks). 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 NCT00951080, 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 1 Aug 2022.