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

Vomaris Innovations

Status and phase: Completed; Phase 2

Conditions: Wound Healing

Treatments: Device: Procellera™ Wound Dressing with V.A.C.® Therapy; Device: V.A.C.® Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022216

XSMP-013

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

V.A.C.® Therapy

Active Comparator group

Description:

Vacuum Assisted Closure device that utilizes controlled negative pressure

Treatment:

Device: V.A.C.® Therapy

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

Experimental group

Description:

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

Treatment:

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