Skip to main content
OpenTrials
Completed

NCT Number: NCT01022216

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wound Healing Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wyckoff Heights Medical Center

Brooklyn, New York, 11237, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Other names: PROCELLERA™, PROSIT™, Bioelectric

V.A.C.® Therapy

Device

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

Other names: Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,

Primary outcomes

  1. Wound healing over time

    Time frame: 3 months after enrollment

Secondary outcomes

  1. Pain reduction

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Vomaris Innovations

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2009
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.