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

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ClinicalTrials.gov Identifier: NCT01022216
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : February 22, 2012
Sponsor:
Information provided by:
Vomaris Innovations

Tracking Information
First Submitted Date  ICMJE November 24, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Wound healing over time [ Time Frame: 3 months after enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01022216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Pain reduction [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wound Healing
Intervention  ICMJE
  • 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
  • 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,
Study Arms  ICMJE
  • Active Comparator: V.A.C.® Therapy
    Vacuum Assisted Closure device that utilizes controlled negative pressure
    Intervention: Device: 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
    Intervention: Device: Procellera™ Wound Dressing with V.A.C.® Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 25, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022216
Other Study ID Numbers  ICMJE XSMP-013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald Guberman, DPM, Director, Podiatric Medical Education, Wyckoff Heights Medical Center
Study Sponsor  ICMJE Vomaris Innovations
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald M Guberman, DPM Wyckoff Heights Medical Center
PRS Account Vomaris Innovations
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP