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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Wound Healing

Intervention / Treatment
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* Device: Procellera™ Wound Dressing with V.A.C.® Therapy
* Device: V.A.C.® Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: V.A.C.® Therapy<br>Vacuum Assisted Closure device that utilizes controlled negative pressure | Device: V.A.C.® Therapy<br>* Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.<br>* Other names: Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,;|
| Experimental: Procellera™ Wound Dressing with V.A.C.® Therapy<br>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<br>* 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.<br>* Other names: PROCELLERA™, PROSIT™, Bioelectric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing over time |  | 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer