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document
Ultrasound therapy for recalcitrant diabetic foot ulcers : results of a randomized , double-blind , controlled , multicenter study . An estimated 15 % of patients with diabetes will develop a foot ulcer sometime in their life , making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population . To determine the safety and efficacy of a new , non-contact , kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized , double-blinded , sham-controlled , multicenter study was conducted in hospital-based and private wound care clinics . Patients ( 55 met criteria for efficacy analysis ) received standard of care , which included products that provide a moist environment , offloading diabetic shoes and socks , debridement , wound evaluation , and measurement . The " therapy " was either active 40 KHz ultrasound delivered by a saline mist or a " sham device " which delivered a saline mist without the use of ultrasound . After 12 weeks of care , the proportion of wounds healed ( defined as complete epithelialization without drainage ) in the active ultrasound therapy device group was significantly higher than that in the sham control group ( 40.7 % versus 14.3 % , P = 0.0366 , Fisher 's exact test ) . The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted . Of interest , wounds were debrided at baseline followed by a quantitative culture biopsy . The results of these cultures demonstrated a significant bioburden ( greater than 10 ( 5 ) ) in the majority of cases , despite a lack of clinical signs of infection . Compared to control , this therapeutic modality was found to increase the healing rate of recalcitrant , diabetic foot ulcers .
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Intervention_Physical
Ultrasound therapy
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Intervention_Physical
non-contact , kilohertz ultrasound therapy
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Intervention_Physical
active 40 KHz ultrasound delivered by a saline mist or a "
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Intervention_Control
sham device " which delivered a saline mist without the use of ultrasound
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Intervention_Physical
ultrasound treatment
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Outcome_Physical
recalcitrant diabetic foot ulcers
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Outcome_Physical
foot ulcer
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Outcome_Physical
recalcitrant diabetic foot ulcers
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Outcome_Physical
proportion of wounds healed
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Outcome_Adverse-effects
adverse events
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Outcome_Physical
bioburden
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Outcome_Other
healing rate
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Participant_Condition
recalcitrant diabetic foot ulcers
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Participant_Condition
recalcitrant diabetic foot ulcers
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Participant_Sample-size
55