• 1.

    Lipsky, BA, AR Berendt, HG Deery, et al. :Diagnosis and treatment of diabetic foot infections. .Clin Infect Dis 39::885. ,2004. .

  • 2.

    Nelson, EA, S O’Meara, S Golder, et al. :Systematic review of antimicrobial treatments for diabetic foot ulcers. .Diabet Med 23::348. ,2006. .

  • 3.

    Goldenheim, PD . :An appraisal of povidone-iodine and wound healing. .Postgrad Med J 69 ( suppl 3:):S97. ,1993. .

  • 4.

    Gutierrez, AA . :The science behind stable, super-oxidized water: exploring the various applications of super-oxidized solutions. .Wounds Compend Clin Res Pract 18 ( suppl:):7. ,2006. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Nagamatsu, Y, KK Chen, K Tajima, et al. :Durability of bactericidal activity in electrolyzed neutral water by storage. .Dent Mater J 21::93. ,2002. .

  • 6.

    Chittoria, RK, M Yootla, LM Sampatrao, et al. :The role of super oxidized solution in the management of diabetic food ulcer: our experience. .Nepal Med Coll J 9::125. ,2007. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Nakae, H and H Inaba. :Effectiveness of hydrolyzed water irrigation in a burn-wound infection model. .J Trauma 49::511. ,2000. .

  • 8.

    Tanaka, H, Y Hirakata, M Kaku, et al. :Antimicrobial activity of superoxidized water. .J Hosp Infect 34::43. ,1996. .

  • 9.

    Ohno, H, M Higashidate, and T Yokosuka. :Mediastinal irrigation with superoxidized water after open-heart surgery: the safety and pitfalls of cardiovascular surgical application. .Surg Today 30::1055. ,2000. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    Wolvos, TA . :Advanced wound care with stable super-oxidized water: a look at how combination therapy can optimize wound healing. .Wounds Compend Clin Res Pract 18 ( suppl:):11. ,2006. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11.

    Allie, DE . :Super-oxidized Microcyn technology in lower-extremity wounds. .Wounds Compend Clin Res Pract 18 ( suppl:):3. ,2006. .

  • 12.

    Dalla-Paola, L, E Brocco, A Senesi, et al. :Use of Microcyn Rx, a new antiseptic agent for the treatment of diabetic foot ulcers. .J Wound Healing 2::201. ,2005. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Goretti, C, S Mazzurco, L Ambrosini-Nobili, et al. :Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. .Lower Extrem Wounds 6::22. ,2007. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14.

    Hadi, SF, T Khaliq, N Bilal, et al. :Treating infected diabetic wounds with superoxidized water as anti-septic agent: a preliminary experience. .J Coll Phys Surg Pak 17::740. ,2007. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15.

    Martinez-de, Jesus, FR Ramos-de, A la Medina, JM Remes-Troche, et al. :Efficacy and safety of neutral pH superoxidised solution in severe diabetic foot infections. .Int Would J 4::353. ,2007. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16.

    Dalla-Paola, L, E Brocco, A Senesi, et al. :Super-oxidized solution (SOS) therapy for infected diabetic foot ulcers. .Wounds Compend Clin Res Pract 18::262. ,2006. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17.

    Ricci, E, S Astolfi, and R Cassino. :Clinical results about an antimicrobial solution (Microcyn Rx® Wound Care) in the treatment of infected chronic wounds. .Paper presented at: European Wound Management Association,May 3, 2007;Glasgow, England.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18.

    Armstrong, DG, LA Lavery, and LB Harkless. :Validation of a diabetic wound classification system: the contribution of depth, infection, and ischemia to risk of amputation. .Diabet Care 21::855. ,1998. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation

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

Adam Landsman Podiatric Surgery, Harvard Medical School/Cambridge Health Alliance, Cambridge, MA

Search for other papers by Adam Landsman in
Current site
Google Scholar
PubMed
Close
 DPM, PhD
,
Peter A. Blume Surgery, Orthopedics, and Rehabilitation, Yale School of Medicine, New Haven, CT

Search for other papers by Peter A. Blume in
Current site
Google Scholar
PubMed
Close
 DPM
,
Douglas A. Jordan Jr. Clinical Research of Tampa Bay, Port Richey, FL

Search for other papers by Douglas A. Jordan Jr. in
Current site
Google Scholar
PubMed
Close
 DPM
,
Dean Vayser Scripps, San Diego, CA

Search for other papers by Dean Vayser in
Current site
Google Scholar
PubMed
Close
 DPM
, and
Andres Gutierrez Oculus Innovative Sciences, Petaluma, CA

Search for other papers by Andres Gutierrez in
Current site
Google Scholar
PubMed
Close
 MD, PhD

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. (J Am Podiatr Med Assoc 101(6): 484–496, 2011)

Corresponding author: Adam Landsman, DPM, PhD, Podiatric Surgery, Harvard Medical School/Cambridge Health Alliance, 1493 Cambridge St, Cambridge, MA 02139. (E-mail: adamlandsman@aol.com)
Save