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

NCT ID: NCT01022216

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-11-30

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

V.A.C.® Therapy

Vacuum Assisted Closure device that utilizes controlled negative pressure

Group Type: ACTIVE_COMPARATOR

V.A.C.® Therapy

Intervention Type: DEVICE

Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.

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

Group Type: EXPERIMENTAL

Procellera™ Wound Dressing with V.A.C.® Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

V.A.C.® Therapy

Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.

Intervention Type: DEVICE

Other Intervention Names

PROCELLERA™, PROSIT™, Bioelectric; Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vomaris Innovations

INDUSTRY

Sponsor Role: lead

Responsible Party

Wyckoff Heights Medical Center

Principal Investigators

Ronald M Guberman, DPM

Role: PRINCIPAL_INVESTIGATOR

Wyckoff Heights Medical Center

Locations

Wyckoff Heights Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

XSMP-013

Identifier Type: -

Identifier Source: org_study_id