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

This study has been completed.
Sponsor:
Information provided by:
Vomaris Innovations
ClinicalTrials.gov Identifier:
NCT01022216
First received: November 24, 2009
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Wound Healing
Device: Procellera™ Wound Dressing with V.A.C.® Therapy
Device: V.A.C.® Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vomaris Innovations:

Primary Outcome Measures:
  • Wound healing over time [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022216

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

No publications provided

Responsible Party: Ronald Guberman, DPM, Director, Podiatric Medical Education, Wyckoff Heights Medical Center
ClinicalTrials.gov Identifier: NCT01022216     History of Changes
Other Study ID Numbers: XSMP-013
Study First Received: November 24, 2009
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vomaris Innovations:
Wound
Skin lesion
Antimicrobial
Bioelectric
Diabetic foot
Pressure Ulcer

Additional relevant MeSH terms:
Pressure Ulcer
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 25, 2014