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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01022216

Enrollment

Registered

2009-12-01

Start date

2009-08-31

Completion date

2011-11-30

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Keywords

Wound, Skin lesion, Antimicrobial, Bioelectric, Diabetic foot, Pressure Ulcer

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.

Interventions

DEVICEProcellera™ 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.

DEVICEV.A.C.® Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Wound healing over time	3 months after enrollment

Secondary

Measure	Time frame
Pain reduction	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026