Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006.

OBJECTIVE

To evaluate the clinical role of a novel, noncontact, low-intensity, low-frequency ultrasound therapy (MIST Therapy) in the treatment of nonhealing leg and foot ulcers associated with chronic critical limb ischemia.

DESIGN

Prospective, parallel-group, randomized, controlled trial.

SETTING

A multidisciplinary, vascular wound-healing clinic.

PATIENTS

Thirty-five patients who received MIST Therapy plus the standard of wound care (treatment group) and 35 patients who received the standard of wound care alone (control group).

INTERVENTIONS

Standard of wound care alone or standard of wound care plus MIST Therapy for 12 weeks or until fully healed. MIST Therapy was administered 3 times per week for 5 minutes per treatment.

MAIN OUTCOME MEASURE

Percentage of patients with greater than 50% reduction in wound size from the index measurement after 12 weeks of treatment. The relationship of transcutaneous oximetry pressure in the supine and dependent position was evaluated as a factor in assessing the potential to heal ischemic ulcerations of the foot and leg.

MAIN RESULTS

A significantly higher percentage of patients treated with the standard of care plus MIST Therapy achieved greater than 50% wound healing at 12 weeks than those treated with the standard of care alone (63% vs 29%; P < .001). Thus, failure to achieve the minimum wound healing requirement occurred in 37% of patients in the treatment group and 71% of patients in the control group. The predictive value of baseline transcutaneous oxygen pressure may benefit the clinician when assessing the potential to heal ischemic wounds.

CONCLUSION

The rate of healing of cutaneous foot and leg ulcerations in patients with chronic critical limb ischemia improved significantly when MIST Therapy was combined with the standard of wound care.