036 MIST Ultrasound: The results of a multicenter, randomized, double-blind, sham-controlled trial of the healing of diabetic foot ulcers

Abstract

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 noncontact ultrasound device. Standard of care included moist dressings, debridement, offloading, and adequacy 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. Sixty-six patients were entered with intent to treat. Fifty-five patients were evaluable and constitute the outcomes of the study. MIST therapy resulted in 42.3% rate of healing versus 14.3% for sham treated significant at 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) 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. Acknowledgments: This study was funded by Celleration Inc. Eden Prairie, MN.