NCT01022216

Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers

A Randomized, Controlled Trial of the Procellera™ Wound Dressing Used With Negative Pressure Wound Therapy (NPWT) in the Healing of Diabetic and Pressure Ulcers of the Foot

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vomaris Innovations · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.

Conditions

• Wound Healing

Interventions

Type	Name	Description
DEVICE	Procellera™ Wound Dressing with V.A.C.® Therapy	Dressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT.
DEVICE	V.A.C.® Therapy	Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2011-11-01
• First posted: 2009-12-01
• Last updated: 2012-02-22

Locations

1 site across 1 country: United States