Abstract | OBJECTIVE: 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.
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Authors | Peter A Blume, Jodi Walters, Wyatt Payne, Jose Ayala, John Lantis |
Journal | Diabetes care
(Diabetes Care)
Vol. 31
Issue 4
Pg. 631-6
(Apr 2008)
ISSN: 1935-5548 [Electronic] United States |
PMID | 18162494
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Alginates
- Debridement
- Diabetic Foot
(therapy)
- Female
- Foot Ulcer
(therapy)
- Home Care Services
- Humans
- Hydrogels
- Male
- Middle Aged
- Negative-Pressure Wound Therapy
(methods)
- Wound Healing
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