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
- Peter A. Blume, DPM (peter.b{at}snet.net)1,
- Jodi Walters, DPM2,
- Wyatt Payne, MD3,
- Jose Ayala, MD4 and
- John Lantis, MD5
- 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
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.
Conclusions: This study was registered with ClinicalTrials.gov as NCT00432965.
Footnotes
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- Received November 19, 2007.
- Accepted December 18, 2007.
- Copyright © American Diabetes Association
