An open-label, three-arm pilot study of the safety and efficacy of topical Microcyn Rx wound care versus oral levofloxacin versus combined therapy for mild diabetic foot infections

J Am Podiatr Med Assoc. Nov-Dec 2011;101(6):484-96. doi: 10.7547/1010484.

Abstract

Background: This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers.

Methods: Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4).

Results: In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline-treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx-treated patients.

Conclusions: Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage
  • Diabetic Foot / complications*
  • Diabetic Foot / diagnosis
  • Diabetic Foot / drug therapy
  • Disinfectants
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Hydrogen Peroxide / administration & dosage*
  • Levofloxacin*
  • Male
  • Middle Aged
  • Ofloxacin / administration & dosage*
  • Pilot Projects
  • Prospective Studies
  • Therapeutic Irrigation
  • Treatment Outcome
  • Wound Healing
  • Wound Infection / drug therapy*
  • Wound Infection / etiology
  • Wound Infection / pathology

Substances

  • Anti-Bacterial Agents
  • Disinfectants
  • superoxidized water
  • Levofloxacin
  • Ofloxacin
  • Hydrogen Peroxide