The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
164
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.
ILD Consulting, Inc.
Carlsbad, California, United States
Valley Foot & Ankle Specialty Providers
Fresno, California, United States
Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Time frame: Baseline through 12 weeks
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
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The Sun Healthcare & Surgery Group
Martinez, California, United States
Center for Clincial Research
San Francisco, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
University of Miami
Miami, Florida, United States
NW University Feinberg School of Medicine
Chicago, Illinois, United States
Rosalind Franklin University of Med & Science
North Chicago, Illinois, United States
Ochsner Health System
New Orleans, Louisiana, United States
Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States
...and 7 more locations
Time frame: Baseline through 12 weeks