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Medicine: Evidence-Based Research: Plenary Session
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Moderator: George T. Rodeheaver, PhD Abstract This session will present new evidence-based data from recently performed clinical trails to be chosen before the meeting. Dr. Rodeheaver will moderate the session and provide introductions where appropriate. (Presentation 23.3) MIST ultrasound: the results of a multi-center, randomized, double-blind, sham-controlled trial of the healing of diabetic foot ulcers William J. Ennis, DO, MBA, FACOS; Patricio Meneses, PhD, Advocate Christ Medical Center Wound Treatment Program, Oaklawn, Ill Study design: A prospective, randomized, sham-controlled, double-blinded study of diabetic foot ulcers was conducted to answer questions of safety and impact on wound healing of a non-contact ultrasound device. Standard of care included moist dressings, debridement, offloading, and adequacy of vascular supply for both groups. Patients were randomized to receive a saline mist or 40 KHz ultrasound therapy delivered to the wound bed using the spray as the coupler. The study was 12 weeks in duration or until the wound closed. Results: Sixty three patients were entered with intent to treat. Fifty five patients were evaluable and constitute the outcomes of the study. MIST therapy resulted in 41% rate of healing vs. 14.3% for sham treated, significant at p 0.028 Chi-square. Kaplan Meier survival plots resulted in p<0.0087 Log Rank and p<0.011 Wilcoxon. Rate of wound closure was 22% faster with MIST compared to sham-treated patients. There was no statistically significant difference with regard to adverse events in any category (mild, moderate, or severe). Conclusions: MIST ultrasound therapy is a new, safe, novel FDA cleared device that improves diabetic foot ulcer healing compared to standard of care. Details of the study will be presented. This study was supported by a grant from Celleration Inc., Eden Prairie, Minn. |
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