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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022216
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : February 22, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Wound Healing Device: Procellera™ Wound Dressing with V.A.C.® Therapy Device: V.A.C.® Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: V.A.C.® Therapy
Vacuum Assisted Closure device that utilizes controlled negative pressure
Device: V.A.C.® Therapy
Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.
Other Name: Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,

Experimental: 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
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.
Other Name: PROCELLERA™, PROSIT™, Bioelectric

Primary Outcome Measures :
  1. Wound healing over time [ Time Frame: 3 months after enrollment ]

Secondary Outcome Measures :
  1. Pain reduction [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022216

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United States, New York
Wyckoff Heights Medical Center
Brooklyn, New York, United States, 11237
Sponsors and Collaborators
Vomaris Innovations
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Principal Investigator: Ronald M Guberman, DPM Wyckoff Heights Medical Center

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Responsible Party: Ronald Guberman, DPM, Director, Podiatric Medical Education, Wyckoff Heights Medical Center Identifier: NCT01022216    
Other Study ID Numbers: XSMP-013
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Vomaris Innovations:
Skin lesion
Diabetic foot
Pressure Ulcer
Additional relevant MeSH terms:
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Pressure Ulcer
Wounds and Injuries
Skin Ulcer
Skin Diseases