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

NACompletedINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

July 2, 2015

Primary Completion Date

November 14, 2017

Study Completion Date

November 14, 2017

Conditions
Venous Leg UlcersDiabetic Foot Ulcers
Interventions
DEVICE

PICO System

Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

DEVICE

tNPWT System

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.

Trial Locations (17)

19610

Center for Advanced Wound Care, Wyomissing

21215

Rubin Institute for Advanced Orthopedics, Baltimore

24013

Carilion Clinic, Roanoke

33125

University of Miami, Miami

60064

Rosalind Franklin University of Med & Science, North Chicago

60611

NW University Feinberg School of Medicine, Chicago

70121

Ochsner Health System, New Orleans

76104

Acclaim Bone & Joint, Fort Worth

78501

Futuro Clinical Trials, LLC, McAllen

89119

Advanced Foot & Ankle, Las Vegas

91342

Olive View - UCLA Medical Center, Sylmar

92009

ILD Consulting, Inc., Carlsbad

93720

Valley Foot & Ankle Specialty Providers, Fresno

94115

Center for Clincial Research, San Francisco

94553

The Sun Healthcare & Surgery Group, Martinez

L8R 2R3

The Mayer Institute, Hamilton

J4B 5E4

Centre podiatrique et soins des plaies, Boucherville

All Listed Sponsors
lead

Smith & Nephew, Inc.

INDUSTRY

NCT02470806 - Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT) | Biotech Hunter | Biotech Hunter