Blume PA, Walters J, Payne W, Ayala J, Lantis J, et al.
Diabetes care. Date of publication 2008 Apr 1;volume 31(4):631-6.
1. Diabetes Care. 2008 Apr;31(4):631-6. Epub 2007 Dec 27.
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.
Blume PA(1), Walters J, Payne W, Ayala J, Lantis J.
Author information:
(1)North American Center for Limb Preservation, 506 Blake St., New Haven, CT
06515, USA. peter.b@snet.net
Comment in
Diabetes Care. 2008 Oct;31(10):e76; author reply e77.
Evid Based Nurs. 2008 Oct;11(4):116.
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.
DOI: 10.2337/dc07-2196
PMID: 18162494 [Indexed for MEDLINE]
