NCT01022216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

November 24, 2009

Last Update Submit

February 20, 2012

Conditions

Wound Healing

Keywords

WoundSkin lesionAntimicrobialBioelectricDiabetic footPressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Wound healing over time

    3 months after enrollment

Secondary Outcomes (1)

  • Pain reduction

    3 months

Study Arms (2)

V.A.C.® Therapy

ACTIVE COMPARATOR

Vacuum Assisted Closure device that utilizes controlled negative pressure

Device: V.A.C.® Therapy

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

EXPERIMENTAL

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

Interventions

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

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.

Also known as: PROCELLERA™, PROSIT™, Bioelectric
Procellera™ Wound Dressing with V.A.C.® Therapy
V.A.C.® TherapyDEVICE

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

Also known as: Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,
V.A.C.® Therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wyckoff Heights Medical Center

Brooklyn, New York, 11237, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesDiabetic FootPressure Ulcer

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Ronald M Guberman, DPM

    Wyckoff Heights Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2009

First Posted

December 1, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

US(1)