Clinical Trial: Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot
Brief Summary: The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.
Detailed Summary:
Sponsor: KCI USA, Inc.
Current Primary Outcome: To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure
- To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study
- To determine the change in wound area over time
- To determine the incidence of complications
- To determine the effect of V.A.C. ® Therapy on the quality of life
Original Secondary Outcome: Same as current
Information By: KCI USA, Inc.
Dates:
Date Received: September 21, 2005
Date Started: May 2002
Date Completion: October 2005
Last Updated: July 19, 2006
Last Verified: September 2005
