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.
Author(s): Blume PA, Walters J, Payne W, Ayala J, Lantis J
Affiliation(s): North American Center for Limb Preservation 506 Blake Street, New Haven, CT 06515.
Publication date & source: 2007-12-27, Diabetes Care., [Epub ahead of print]
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.