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news.Kinetic Concepts or KCI has reported the final efficacy results of a randomized controlled clinical trial on the clinical efficacy of the company's VAC System negative pressure wound therapy compared to advanced moist wound therapy to treat diabetic patients with foot ulcers.
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The study has involved 342 patients with complex, hard-to-heal diabetic foot ulcers with 90% of therapy days occurring in the home care setting. In the study, for patients on VAC therapy, complete ulcer closure was significantly greater than for those patients on advanced moist wound therapy or AMWT (43.2% vs. 28.9%, p=0.007).
Patients treated with VAC therapy healed significantly (p=0.001) faster (Kaplan-Meier median estimate time to 100% ulcer closure = 96 days) compared to AMWT (time to 100% ulcer closure not determinable). In addition, significantly fewer amputations were observed in VAC therapy patients compared to AMWT (4.1% vs. 10.2%, p=0.035). In assessing safety, the study showed that no significant difference between the groups was observed.