ISSN:
1524-475X
Source:
Blackwell Publishing Journal Backfiles 1879-2005
Topics:
Medicine
Notes:
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.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1111/j.1067-1927.2005.130215aj.x
