SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
NCT ID: NCT00951080
Last Updated: 2022-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2009-07-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SNaP Wound Care System
SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Traditional NPWT System
Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
Interventions
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Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Responsible Party
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Principal Investigators
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David G Armstrong, DPM, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Southern Arizona Limb Salvage Alliance (SALSA)
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States
Center for Clinical Research, Inc.
Castro Valley, California, United States
Jay Mukker, DPM Inc.
Fresno, California, United States
Palomar Pomerado Health Wound Care Center
Poway, California, United States
O'Connor Wound Care Clinic
San Jose, California, United States
John Muir Wound Care Center
Walnut Creek, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Bethesda Health City Wound Care Center
Boynton Beach, Florida, United States
Wound Care on Wheels, LLC
Jacksonville, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, United States
LA Cardiovascular & Limb Salvage Center
Lafayette, Louisiana, United States
University of North Carolina
Chapel Hill, North Carolina, United States
The Christ Hospital, Wound Healing Center
Cincinnati, Ohio, United States
New Bridge Medical Research Corporation
Warren, Pennsylvania, United States
Southwest Washington Medical Center Wound Healing Center
Vancouver, Washington, United States
Countries
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References
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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.
Other Identifiers
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SNP041609
Identifier Type: -
Identifier Source: org_study_id
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