Comparison of Negative Pressure Wound Therapy Using Vac...

Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted Closure With Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers

Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted Closure With Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers
Published online December 27, 2007
Peter A. Blume, DPM1, Jodi Walters, DPM2, Wyatt Payne, MD3, Jose Ayala, DPM4 and John Lantis, MD5
Diabetes Care
© 2008 by the American Diabetes Association

Clinical Care/Education/Nutrition/Psychosocial Research
Original Research

A multicenter randomized controlled trial

1 North American Center for Limb Preservation, New Haven, Connecticut
2 Southern Arizona Veterans Affairs Medical Center, Surgery, Tucson, Arizona
3 Institute for Tissue Regeneration, Repair, and Rehabilitation, Bay Pines VA Healthcare System, Bay Pines, Florida, and the University of South Florida, Division of Plastic Surgery, Tampa, Florida
4 Valley Baptist Hospital, Brownsville, Texas
5 Saint Luke's Roosevelt Hospital, New York, New York

Address correspondence and reprint requests to Dr. Peter A. Blume, North American Center for Limb Preservation, 506 Blake St., New Haven, CT 06515. E-mail: peter.b@snet.net

ABSTRACT

OBJECTIVE—The purpose of this study was to evaluate safety and clinical efficacy of negative pressure wound therapy (NPWT) compared with advanced moist wound therapy (AMWT) to treat foot ulcers in diabetic patients.

RESEARCH DESIGN AND METHODS—This multicenter randomized controlled trial enrolled 342 patients with a mean age of 58 years; 79% were male. Complete ulcer closure was defined as skin closure (100% reepithelization) without drainage or dressing requirements. Patients were randomly assigned to either NPWT (vacuum-assisted closure) or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. The trial evaluated treatment until day 112 or ulcer closure by any means. Patients whose wounds achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound examination and tracings.

RESULTS—A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of 169, 43.2%) than with AMWT (48 of 166, 28.9%) within the 112-day active treatment phase (P = 0.007). The Kaplan-Meier median estimate for 100% ulcer closure was 96 days (95% CI 75.0–114.0) for NPWT and not determinable for AMWT (P = 0.001). NPWT patients experienced significantly (P = 0.035) fewer secondary amputations. The proportion of home care therapy days to total therapy days for NPWT was 9,471 of 10,579 (89.5%) and 12,210 of 12,810 (95.3%) for AMWT. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months.

CONCLUSIONS—NPWT appears to be as safe as and more efficacious than AMWT for the treatment of diabetic foot ulcers.

Abbreviations: AMWT, advanced moist wound therapy • ATP, active treatment phase • DFU, diabetic foot ulcer • ITT, intention-to-treat • NPWT, negative pressure wound therapy • RCT, randomized controlled trial

INTRODUCTION

In 2005, the Centers for Disease Control and Prevention estimated the prevalence of diabetes in the U.S. to be 20.8 million people (1). A disabling complication with this disease is foot ulcer development (2,3), which leads to nonhealing chronic wounds that are difficult to treat. Moreover, diabetic foot ulcers (DFUs) are a significant risk factor for nontraumatic foot amputations in individuals with diabetes (4).

Various DFU treatments have been reported in the literature, including advanced moist wound therapy (AMWT) (5,6), bioengineered tissue or skin substitutes (7,8), growth factors (9,10), electric stimulation (11), and negative pressure wound therapy (NPWT) (12). Treatment success depends on ulcer chronicity, patient compliance, appropriate off-loading of the appendage, and the mechanisms of action of the therapy.

NPWT is a noninvasive system that creates a localized controlled subatmospheric (negative) pressure environment. In this study, NPWT was provided by the V.A.C. Therapy system (KCI USA, San Antonio, TX), which promotes wound healing by delayed primary or secondary intention through creating a moist wound environment, preparing the wound bed for closure, reducing edema, and promoting formation and perfusion of granulation tissue. Vacuum-assisted closure therapy is indicated for use in all care settings and for a variety of wound types including diabetic foot ulcers.

This multicenter randomized controlled trial (RCT) evaluated the safety and efficacy of NPWT compared with AMWT (predominately hydrogels and alginates) for the treatment of DFUs. The cost-benefit analysis will be reported in a future publication.

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