Blume PA, Walters J, Payne W, Ayala J, Lantis J.
North American Center for Limb Preservation 506 Blake Street,
New Haven, CT 06515.
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.
PMID: 18162494 [PubMed - as supplied by publisher]
This abstract has been taken from the PubMed
website