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

Wound Healing Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022216
• Other study ID #: XSMP-013
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2009
• Last updated: February 20, 2012
• Start date: August 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Vomaris Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Wound Healing

Intervention

Device:
• Procellera™ 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.
• V.A.C.® Therapy
Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.

Locations

Country	Name	City	State
United States	Wyckoff Heights Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vomaris Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing over time		3 months after enrollment	Yes
Secondary	Pain reduction		3 months	No