NCT03450616

Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.

Detailed description

This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers. The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care. The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	PICO Negative Pressure Wound Therapy	Negative Pressure Wound Therapy Device
PROCEDURE	Compression Dressing	Standard of Care Compression Dressing

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-03-01
• Last updated: 2019-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study