A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds

Summary

The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation. To determine this, measures of healing, quality of life, and utilization costs associated with this approach will be analyzed. KCI believes that information obtained from this study will show V.A.C. NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective, cost-efficient healthcare solution.

Conditions

• Diabetic Amputation Foot Wound

Interventions

DEVICE

V.A.C. Therapy

Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.

DEVICE

Moist wound therapy (MWT)

Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial

Sponsors & Collaborators

• KCI USA, Inc

  lead INDUSTRY

Principal Investigators

• Peter Blume, DPM, F.A.C.F.A.S · North American Center for Limb Preservation

• Brent Bernstein, DPM, F.A.C.F.A.S · St. Lukes Allentown & Bethlehem

• Marc Corriveau, M.D. · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Vickie Driver, M.D. · Boston University

• Stephan Elkouri, MD, MSc, FRCSC, FAC · Centre Hospitalierde l'Universite' de Montreal (CHUM)

• Luis Esquerdo, DPM · Esquerdo Podiatric Center

• Christopher Gauland, MD · Eastern Carolina Foot and Ankle

• Vivian Halpern, MD · North Shore University Hospital

• Jason Hanft, DPM · Doctor's Research Network

• Adam Landsman, DPM, PhD. · Beth Israel Deaconess Medical Center Division of Podiatry, Baker 3

• John Lantus, MD · St. Lukes-Roosevelt Hospital Center

• James Mahoney, MD, FRCS · Division of Plastic Surgery- St. Michael's Hospital

• Jose Mattei, MD, DPM · CTI Network Inc

• Kenneth McIntyre, MD · Mike O'Callaghan Military Hospital

• Christopher Moore, DPM · Moore Foot & Ankle Specialists, PA

• Lili Moore, DPM · Moore Foot & Ankle Specialists, PA

• Wyatt Payne, MD · Bay Pines VAHCS

• Rodney Stuck, DPM · Hines VA Hospital

• Jodi Walters, DPM · Southern Arizona VA Healthe Care System

• Joseph Whitlark, MD · Comprehensive Wound Care, Inc

• Thomas Zgonis, MD · University of Texas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2008-04-30

Completion

2008-04-30