SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
1 other identifier
interventional
132
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2009
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 31, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedAugust 1, 2022
July 1, 2022
1.7 years
July 31, 2009
September 21, 2020
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and 16 weeks
Study Arms (2)
SNaP Wound Care System
EXPERIMENTALTraditional NPWT System
ACTIVE COMPARATORInterventions
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 3Mlead
Study Sites (17)
Hope Research Institute
Phoenix, Arizona, 85050, United States
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, 85724, United States
Center for Clinical Research, Inc.
Castro Valley, California, 94546, United States
Jay Mukker, DPM Inc.
Fresno, California, 93726, United States
Palomar Pomerado Health Wound Care Center
Poway, California, 92078, United States
O'Connor Wound Care Clinic
San Jose, California, 95128, United States
John Muir Wound Care Center
Walnut Creek, California, 94598, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Bethesda Health City Wound Care Center
Boynton Beach, Florida, 33437, United States
Wound Care on Wheels, LLC
Jacksonville, Florida, 32216, United States
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
LA Cardiovascular & Limb Salvage Center
Lafayette, Louisiana, 70506, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
The Christ Hospital, Wound Healing Center
Cincinnati, Ohio, 45219, United States
New Bridge Medical Research Corporation
Warren, Pennsylvania, 16365, United States
Southwest Washington Medical Center Wound Healing Center
Vancouver, Washington, 98664, United States
Related Publications (1)
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.
PMID: 21362084RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Global Clinical Development
- Organization
- KCI
Study Officials
- PRINCIPAL INVESTIGATOR
David G Armstrong, DPM, Ph.D.
Southern Arizona Limb Salvage Alliance (SALSA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 4, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
August 1, 2022
Results First Posted
October 19, 2020
Record last verified: 2022-07