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

NCT01022216 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-02-22

No results posted yet for this study

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.

Conditions

  • Wound Healing

Interventions

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.

DEVICE

V.A.C.® Therapy

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

Sponsors & Collaborators

  • Vomaris Innovations

    lead INDUSTRY

Principal Investigators

  • Ronald M Guberman, DPM · Wyckoff Heights Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-08-31
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022216 on ClinicalTrials.gov