Clinical Trials Directory

Trials / Completed

CompletedNCT00432965

Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
335 (actual)
Sponsor
KCI USA, Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers. The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.

Conditions

Interventions

TypeNameDescription
DEVICEMoist Wound TherapyMoist Wound Therapy (Standard of Care)
DEVICEVAC TherapyVAC Therapy

Timeline

Start date
2002-05-01
Primary completion
2008-03-01
Completion
2008-03-01
First posted
2007-02-08
Last updated
2024-10-16
Results posted
2017-11-13

Locations

25 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00432965. Inclusion in this directory is not an endorsement.