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

Phase 2

Completed

• Conditions: Wound Healing
• Interventions: Device: Procellera™ Wound Dressing with V.A.C.® Therapy; Device: V.A.C.® Therapy

• Registration Number: NCT01022216
• Lead Sponsor: Vomaris Innovations

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-12-01
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Wound size greater than 1x1 cm
• Wounds must be ≥5 cm away from all other wounds
• Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
• Participant must be candidate for negative pressure wound therapy
• Participant agrees to participate in follow-up evaluations
• Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria

• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
• Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
• Participant is to receive Silver granufoam for their wound
• Participant with sensitivity or adverse reactions to silver or zinc
• Pregnancy or nursing an infant or child
• Immunosuppression
• Active or systemic infection
• Participant undergoing active cancer chemotherapy
• Chronic steroid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procellera™ Wound Dressing with V.A.C.® Therapy	Procellera™ Wound Dressing with V.A.C.® Therapy	Procellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT
V.A.C.® Therapy	V.A.C.® Therapy	Vacuum Assisted Closure device that utilizes controlled negative pressure

Primary Outcome Measures

Name	Time	Method
Wound healing over time	3 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Pain reduction	3 months

Trial Locations

Locations (1)

Wyckoff Heights Medical Center; 🇺🇸 Brooklyn, New York, United States