MedTrace Logo

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

NCT00432965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2024-10-16

Study results available
· View outcomes & findings →

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

  • Diabetic Foot Ulcers

Interventions

DEVICE

Moist Wound Therapy

Moist Wound Therapy (Standard of Care)

DEVICE

VAC Therapy

VAC Therapy

Sponsors & Collaborators

  • KCI USA, Inc

    lead INDUSTRY

Principal Investigators

  • Peter Blume, DPM · North American Center for Limb Preservation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432965 on ClinicalTrials.gov