A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers

Status: Completed
Location: See all (17) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provide informed consent

• Age ≥ 18 years and of either sex

• Willing to comply with protocol instructions, including allowing all study assessments

• Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2

• Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)

• Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2

• Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone

• Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)

• Acceptable state of health and nutrition

Locations
United States
California
ILD Consulting, Inc.
Carlsbad
Valley Foot & Ankle Specialty Providers
Fresno
The Sun Healthcare & Surgery Group
Martinez
Center for Clincial Research
San Francisco
Olive View - UCLA Medical Center
Sylmar
Florida
University of Miami
Miami
Illinois
NW University Feinberg School of Medicine
Chicago
Rosalind Franklin University of Med & Science
North Chicago
Louisiana
Ochsner Health System
New Orleans
Maryland
Rubin Institute for Advanced Orthopedics
Baltimore
Nevada
Advanced Foot & Ankle
Las Vegas
Pennsylvania
Center for Advanced Wound Care
Wyomissing
Texas
Acclaim Bone & Joint
Fort Worth
Futuro Clinical Trials, LLC
Mcallen
Virginia
Carilion Clinic
Roanoke
Other Locations
Canada
Centre podiatrique et soins des plaies
Boucherville
The Mayer Institute
Hamilton
Time Frame
Start Date: 2015-07-02
Completion Date: 2017-11-14
Participants
Target number of participants: 164
Treatments
Experimental: PICO System
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Smith & Nephew, Inc.

This content was sourced from clinicaltrials.gov