Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
tNPWT System	tNPWT System	Traditional NPWT (tNPWT) 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.
PICO System	PICO System	Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

Primary Outcome Measures

Name	Time	Method
Change in Ulcer Area From Baseline to the End of the Treatment Period	Baseline through 12 weeks	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.
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period	Baseline through 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Baseline through 12 weeks	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.
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Baseline through 12 weeks	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.
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Baseline through 12 weeks	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.

Locations (17): Valley Foot & Ankle Specialty Providers
🇺🇸
Fresno, California, United States
The Sun Healthcare & Surgery Group
🇺🇸
Martinez, California, United States
NW University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
University of Miami
🇺🇸
Miami, Florida, United States
Rubin Institute for Advanced Orthopedics
🇺🇸
Baltimore, Maryland, United States
Advanced Foot & Ankle
🇺🇸
Las Vegas, Nevada, United States
Center for Clincial Research
🇺🇸
San Francisco, California, United States
ILD Consulting, Inc.
🇺🇸
Carlsbad, California, United States
Olive View - UCLA Medical Center
🇺🇸
Sylmar, California, United States
Rosalind Franklin University of Med & Science
🇺🇸
North Chicago, Illinois, United States
Ochsner Health System
🇺🇸
New Orleans, Louisiana, United States
Futuro Clinical Trials, LLC
🇺🇸
McAllen, Texas, United States
Acclaim Bone & Joint
🇺🇸
Fort Worth, Texas, United States
Center for Advanced Wound Care
🇺🇸
Wyomissing, Pennsylvania, United States
The Mayer Institute
🇨🇦
Hamilton, Ontario, Canada
Centre podiatrique et soins des plaies
🇨🇦
Boucherville, Quebec, Canada
Carilion Clinic
🇺🇸
Roanoke, Virginia, United States