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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
Hope Research Institute
Phoenix, Arizona, United States
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States
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)
Time frame: Baseline and 16 weeks
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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
...and 7 more locations