CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
PICO System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02470806
NCT02470806N/ACompleted
CompareCT.gov

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

Smith & Nephew, Inc.·interventional·Posted Jun 12, 2015·Updated Apr 6, 2020

In Brief

A clinical study evaluating PICO System and tNPWT System for Venous Leg Ulcers and Diabetic Foot Ulcers. Completed, enrolled 164 participants across 17 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Leg Ulcers, Diabetic Foot Ulcers
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartJul 2, 2015
Primary CompletionNov 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.1 years ago

Interventions

PICO Systemdevice

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

tNPWT Systemdevice

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.