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

Completed · Phase 2

Conditions studied: Wound Healing

In brief

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.

Key facts

Study ID

NCT01022216

Run by

Vomaris Innovations

People needed

30

Starts

2009-08-01

Expected to finish

2011-11-01

Last updated by the study team

2012-02-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wyckoff Heights Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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