Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.
- 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
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||October 2005|