At a glance
ClinicalIndex Comparison RecordN/ACompleted· 335 enrolled
Drug / intervention
Moist Wound Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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"
In Brief
A clinical study evaluating Moist Wound Therapy and VAC Therapy for Diabetic Foot Ulcers. Completed, enrolled 335 participants across 25 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcers
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2002
First PostedFeb 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedFeb 8, 2007
Enrollment StartMay 1, 2002
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.4 years ago
Interventions
Moist Wound Therapydevice
Moist Wound Therapy (Standard of Care)
VAC Therapydevice
VAC Therapy