Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted Closure With Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers
A multicenter randomized controlled trial
- Peter A. Blume, DPM1,
- Jodi Walters, DPM2,
- Wyatt Payne, MD3,
- Jose Ayala, DPM4 and
- John Lantis, MD5
- 1North American Center for Limb Preservation, New Haven, Connecticut
- 2Southern Arizona Veterans Affairs Medical Center, Surgery, Tucson, Arizona
- 3Institute 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
- 4Valley Baptist Hospital, Brownsville, Texas
- 5Saint 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{at}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.
- 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
Footnotes
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Published ahead of print at http://care.diabetesjournals.org on 27 December 2007. DOI: 10.2337/dc07-2196. Clinical trial reg. no. NCT00432965, clinicaltrials.gov.
J.C.L. has received honoraria as a speaker for KCI USA.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
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- Accepted December 18, 2007.
- Received November 19, 2007.
- DIABETES CARE
