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

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.

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