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Comparison of Negative Pressure Wound Therapy Utilizing Vacuum-Assisted Closure to Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers– A Multicenter Randomized Controlled Trial

¹North American Center for Limb Preservation 506 Blake Street, New Haven, CT 06515
²Southern Arizona Veterans Affairs Medical Center, Surgery, Tucson, AZ
³Institute for Tissue Regeneration, Repair, and Rehabilitation, Bay Pines VA Healthcare System, Bay Pines, FL and The University of South Florida, Division of Plastic Surgery, Tampa, FL
⁴Valley Baptist Hospital, Brownsville, TX
⁵Saint Luke's Roosevelt, New York, NY

peter.b{at}snet.net

ABSTRACT

Objective: To evaluate safety and clinical efficacy of Negative Pressure Wound Therapy (NPWT) compared to Advanced Moist Wound Therapy (AMWT) to treat diabetic patients with foot ulcers.

Research Design And Methods: This multicenter randomized controlled trial enrolled 342 patients mean age 58 years; 79% male. Complete ulcer closure was defined as skin closure (100% re-epithelization) without drainage or dressing requirements. Patients were randomized 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 wound achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound exam and tracings.

Results: A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73/169, 43.2%) than AMWT (48/166, 28.9%) within the 112-day Active Treatment Phase (p=0.007). 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 9471/10579 (89.5%) and 12210/12810 (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.

This study was registered with ClinicalTrials.gov as NCT00432965.

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This article has been cited by other articles:

				L. G. Hemkens and A. Waltering 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: Response to Blume et al. Diabetes Care, October 1, 2008; 31(10): e76 - e76. [Full Text] [PDF]

				P. A Blume 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: Response to Hemkens and Waltering Diabetes Care, October 1, 2008; 31(10): e77 - e77. [Full Text] [PDF]