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

Primary Purpose

Wound Healing

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Procellera™ Wound Dressing with V.A.C.® Therapy
V.A.C.® Therapy
Sponsored by
Vomaris Innovations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wyckoff Heights Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

V.A.C.® Therapy

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

Arm Description

Vacuum Assisted Closure device that utilizes controlled negative pressure

Procellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT

Outcomes

Primary Outcome Measures

Wound healing over time

Secondary Outcome Measures

Pain reduction

Full Information

First Posted
November 24, 2009
Last Updated
February 20, 2012
Sponsor
Vomaris Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT01022216
Brief Title
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vomaris Innovations

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V.A.C.® Therapy
Arm Type
Active Comparator
Arm Description
Vacuum Assisted Closure device that utilizes controlled negative pressure
Arm Title
Procellera™ Wound Dressing with V.A.C.® Therapy
Arm Type
Experimental
Arm Description
Procellera wound dressing used as a primary contact layer on the wound bed, used in conjunction with NPWT
Intervention Type
Device
Intervention Name(s)
Procellera™ Wound Dressing with V.A.C.® Therapy
Other Intervention Name(s)
PROCELLERA™, PROSIT™, Bioelectric
Intervention Description
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
Intervention Name(s)
V.A.C.® Therapy
Other Intervention Name(s)
Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,
Intervention Description
Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.
Primary Outcome Measure Information:
Title
Wound healing over time
Time Frame
3 months after enrollment
Secondary Outcome Measure Information:
Title
Pain reduction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Guberman, DPM
Organizational Affiliation
Wyckoff Heights Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wyckoff Heights Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11237
Country
United States

12. IPD Sharing Statement

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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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