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Super-Oxidized Solution (SOS) Therapy for Infected Diabetic Foot Ulcers Wounds
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Objective: This study evaluated the efficacy of a novel super-oxidized solution (SOS; Dermacyn® Wound Care, Oculus Innovative Sciences, Petaluma, Calif, USA) compared with a standard treatment (10% povidone iodine solution [PI]) in treating diabetic foot lesions.
Research and design methods: This was an open-label, nonrandomized study. Patients had type 1 or 2 diabetes mellitus and grades 2–3 infected foot ulcers according to the University of Texas classification. Patients were alternately assigned to receive treatment with either SOS (n = 110) or PI (n = 108) with daily dressing changes. Samples were taken from the lesions at baseline and during elective surgery carried out after clinical evidence of infection control. Outcome measures included reduction in bacterial load from the lesion, healing time, and incidence of skin reactions.
Results: The baseline number of bacterial strains at study entry was similar between the 2 groups. During final elective operative treatment, there were significantly more patients without bacterial strains in the SOS group compared with the PI group (P < 0.001), and patients were more likely to be successfully treated with SOS relative to PI (odds ratio 3.4 [95% confidence interval 1.7–7.0]). Patients in the SOS group had significantly shorter median healing time compared with patients in the PI group (43 days versus 55 days, P < 0.0001). No skin reactions occurred in the SOS group in contrast to 18 patients in the PI group who did experience skin reactions.
Conclusions: This study shows SOS is effective and safe in treating infected foot lesions when included within a comprehensive wound care regimen.
Superoxidized solution for infected diabetic foot ulcers
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.
Goretti C, Mazzurco S, Nobili LA, Macchiarini S, Tedeschi A, Palumbo F, Scatena A, Rizzo L, Piaggesi A. Int J Low Extrem Wounds. 2007 Mar;6(1):22-7.
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The safety and efficacy of a novel superoxidized solution (Dermacyntrade mark Wound Care [DWC], Oculus Innovative Sciences, Petaluma, Calif) was evaluated for the treatment of wide postsurgical infected ulcers of the diabetic foot. A group (group A,n = 18) of patients with diabetes mellitus who had postsurgical lesions>5 cm(2) without ischemia or infection were recruited consecutively and treated with DWC-saturated dressings. These dressings were renewed once daily and were compared with a group of patients that had been previously treated with diluted povidone iodine (group B,n = 15) using a quasi-experimental study design. Both sets of patients also received standard systemic antibiotic therapy, as per the practice in this center, and local surgical debridement. Patients had weekly assessments until wounds had re-epithelialized completely. Patients in group A had statistically significant shorter healing time and duration of antibiotic therapy and a higher healing rate at 6 months compared with those in group B (p < .01). Recurrence of infection, requirement for debridement procedures, and requirement for minor amputations were significantly less frequent during follow-up in group A patients (p < .05) when compared with those in group B. These preliminary data suggest that DWC used as a wound dressing together with other local and systemic therapies may have a role in reducing healing time as well as complications in patients with diabetes who have postsurgical lesions of the diabetic foot. These data propose the need for a robust controlled study of DWC-saturated dressings to explore its full potential.
Re: Superoxidized solution for infected diabetic foot ulcers
The role of super oxidized solution in the management of diabetic foot ulcer: our experience.Chittoria RK, Yootla M, Sampatrao LM, Raman SV. Nepal Med Coll J. 2007 Jun;9(2):125-8.
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Dressing or preparation of the diabetic foot ulcer is very essential not only to reduce or prevent infection but also for the preparation for definite surgery, if necessary. Present article is about our experience in the evaluation of effectiveness of super oxidized solution in local treatment of diabetic foot ulcers. Out of 20 cases super oxidized solution helped in total healing in 8 cases, and prepared wounds for definite cover by reducing infection and promoting granulations which are pre requisites for definitive surgery in remaining 12 cases.
Re: Superoxidized solution for infected diabetic foot ulcers
Efficacy and safety of neutral pH superoxidised solution in severe diabetic foot infections.
Martínez-De Jesús FR, Ramos-De la Medina A, Remes-Troche JM, Armstrong DG, Wu SC, Lázaro Martínez JL, Beneit-Montesinos JV. Int Wound J. 2007 Oct 22; [Epub ahead of print]
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The use of antiseptics in wound care is often controversial and there is definitely a need for a non toxic, highly disinfective agent. This study assessed the efficacy of a neutral pH superoxidised aqueous solution (NpHSS) for infection control, odour reduction and surrounding skin and tissue damage on infected diabetic foot ulcerations. From November 2003 to March 2004, 45 patients with type 2 diabetes were randomised into a single-blind clinical trial comparing NpHSS (intervention group; n = 21) versus conventional disinfectant (control group; n = 16). All patients received comprehensive care including surgical debridement as appropriate, moist wound care, intensive glucose control and broad spectrum antibiotics. Treatment groups were matched in terms of sex, age (61.9 +/- 11.9 versus 67.8 +/- 11.6), years of diabetes duration (16.4 +/- 8.1 versus 17 +/- 10.2), obesity, HgAlc (7.1 +/- 2 versus 6.7 +/- 1.8), initial fasting glycaemia (163 +/- 59 versus 152 +/- 65.8 mg/dl), ulcer duration/week (13.7 +/- 24 versus 15.1 +/- 16.3), B/A Index (0.9 +/- 0.5 versus 1.14 +/- 0.7), depth and extent of infection/periwound cellulitis (groups B and C of the Tampico Hospital Classification) as well as aetiology (P = 0.647). Odour reduction was achieved in all NpHSS patients (100% versus 25%; P < 0.01) and surrounding cellulitis diminished (P < 0.001) in 17 patients (80.9% versus 43.7%). Nineteen patients in the NpHSS group showed advancement to granulating tissue stage (90.4% versus 62.5%; P = 0.05) with significantly less tissue toxicity (94% versus 31.2%; P < 0.01). A non toxic, NpHSS, as part of a comprehensive care regimen, may be more efficacious in infection control, odour and erythema reduction than conventional disinfectants in treatment of diabetic foot infections.
Re: Superoxidized solution for infected diabetic foot ulcers
Press Release: Oculus Innovative Sciences Completes Patient Treatment and Follow-up in Its Phase II Clinical Trial in Mildly Infected Diabetic Foot UlcersTop line data on schedule for first calendar quarter 2008 release -- Trial endpoints of microbiologic response, safety and resolution of infection to be evaluated -- Desired outcome of trial is to obtain positive clinical response and safety sufficient to initiate Phase III trials
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Jan 03, 2008 Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) today announced that it has completed patient treatment and follow-up in its randomized and controlled Phase II clinical trial evaluating its Microcyn(R) Technology in the treatment of mildly infected diabetic foot ulcers. The final patient evaluation occurred on December 24, 2007.
Hoji Alimi, chairman and CEO of Oculus Innovative Sciences said, "We are pleased to have successfully completed the Phase II trial in December 2007 and look forward to reporting top line data in Q1 2008.
"The primary objective of the Phase II trial is to provide the clinical basis and rationale for larger Phase III trials. It is not a superiority or wound healing study. The patients enrolled in this trial have been screened to ensure that they have appropriate blood perfusion, thus enabling the antibiotic levofloxacin the opportunity to access and impact the infected ulcer. Our intent is to use the various data points in the Phase II trial as the foundation for moving the company's clinical program forward."
About the Study
The Phase II randomized, controlled open-label study enrolled a total of 67 patients with mildly infected diabetic foot ulcers at 15 U.S. sites. Three treatment arms were evaluated: 1) topical Microcyn alone 2) topical Microcyn in combination with oral levofloxacin; and 3) topical saline in combination with oral levofloxacin. Patient enrollment criteria in all three arms of the study included appropriate blood perfusion as well as mildly infected ulcers based on the IDSA classification of "mild" and University of Texas wound classification of "1B." Patients were randomized and treated for a total of 10 days in all three arms. Designed into the trial were three assessment time points: day 3, day 10, and day 24. This design allows the most flexibility for an optimal design of a Phase III trial based on a number of potential positive signals at various time points.
Levofloxacin was chosen for the control group because it is one of the more potent, broad-spectrum oral antibiotics indicated for the treatment of complicated skin and skin structure infections (including diabetic foot infections) and is recommended by the Infectious Diseases Society of America in its guidelines for treatment of diabetic foot infections.
The company expects to provide preliminary top line Phase II clinical trial results in Q1 of 2008. More detailed results will be submitted for publication and/or presentation in various medical journals and conferences. Further information on this Phase II trial can be found at www.clinicaltrials.gov.
About Oculus
Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn(R) Technology platform, which is intended to help prevent and treat infections in chronic and acute wounds. The Microcyn Technology platform is a biocompatible solution containing active oxychlorine compounds. The solutions derived from the Microcyn Technology platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores. The technology has also demonstrated wound healing in chronic and acute wounds in clinical investigational studies. It has been commercialized outside of the U.S. for the treatment of infected wounds.
Re: Superoxidized solution for infected diabetic foot ulcers
Press Release: Oculus reaches primary endpoint in Phase II trial of Microcyn for foot ulcers
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Oculus Innovative Sciences Inc. (NASDAQ:OCLS) Wednesday said it recorded positive results from a Phase II study evaluating Microcyn Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers.
The study, which evaluated Microcyn as a monotherapy and in combination with systemic antibiotic levofloxacin after 10 days, demonstrated that 75% of patients treated with Microcyn showed a positive clinical result - defined as the clinical cure or improvement of infection - and 64% of patients on the combination therapy showed a positive result.
In the group of patients taking Microcyn only, 30% were cured and 45% showed improvement. In the combination group, 36% of patients were cured and 28% showed improvement.
The company plans to request an end-of-Phase-II meeting with the Food and Drug Administration to discuss the results and define the parameters for advancing the clinical program.
Re: Superoxidized solution for infected diabetic foot ulcers
Press Release: Oculus Innovative Sciences Launches Microcyn® Wound Care for U.S. Podiatry Market
Initial Commercialization Targets Ten Key Metropolitan Regions
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PETALUMA, Calif., Oct 22, 2008 (BUSINESS WIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) today announced that it has launched its Microcyn Wound Care product into the U.S. podiatry market. The product, which has received three FDA 510(k) clearances for use in moistening, lubricating, cleaning and debriding wounds, is available to podiatrists for treatment of, and distribution to, their patients.
"We have begun marketing Microcyn Technology for the U.S. wound care market with an initial focus on the podiatry opportunity," said Hoji Alimi, CEO and founder of Oculus. "Based upon our clinical trial success and positive feedback from our sampling program to U.S. physicians over the past year, we have generated valuable insights into how medical professionals use Microcyn to treat patients. Podiatry was one of the areas in which we witnessed significant patient benefits and positive physician response. By using the services of a contract sales organization, we're able to effectively launch Microcyn in the United States while continuing to reduce our overall expenses."
Results of market analysis and positive product trial of Microcyn Wound Care among U.S. podiatrists have led Oculus to focus its launch initially in New York City/Long Island, Northern New Jersey, Miami, Tampa Bay/St. Petersburg, Chicago, Detroit, Dallas/Ft. Worth, Phoenix, San Jose/San Francisco, and Orange County/Los Angeles. The company contracted a professional marketing and sales management group to spearhead a 10-member sales force in this initial sales effort. Each sales representative's efforts will be supported by advisory boards consisting of practicing podiatrists in their respective sales territory. Upon successful completion of this multi-region introduction, the company plans to expand marketing efforts into other U.S. regions, reaching the more than 15,000 podiatrists in the United States.
Oculus is also pursuing a U.S. drug approval using a different formulation of the Microcyn Technology. The company intends to secure a partner that will assume clinical, regulatory, and commercial responsibilities along with costs for the drug formulation approval.
Re: Superoxidized solution for infected diabetic foot ulcers
A Randomized Controlled Trial to Examine the Efficacy and Safety of a New Super-Oxidized Solution for the Management of Wide Postsurgical Lesions of the Diabetic Foot.
Piaggesi A, Goretti C, Mazzurco S, Tascini C, Leonildi A, Rizzo L, Tedeschi A, Gemignani G, Menichetti F, Del Prato S. Int J Low Extrem Wounds. 2010 Mar;9(1):10-15.
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This randomized trial was done to test the effectiveness and safety of using a novel antiseptic solution (Dermacyn(R) Wound Care [DWC], Oculus Innovative Sciences, Petaluma, CA) in the management of the postoperative lesions on the infected diabetic foot. 40 patients with postsurgical lesions wider than 5 cm2 left open to heal by secondary intention were randomized into 2 groups. Group A was locally treated with DWC, whereas group B received povidone iodine as local medication, both in adjunct to systemic antibiotic therapy and surgical debridement if needed. Ischemia, renal failure, bilateral lesions, or immunodepression were considered as exclusion criteria. Patients were followed up weekly for 6 months. The primary endpoint was healing rate at 6 months, while secondary endpoints were healing time, time to achieve negative cultures, duration of antibiotic therapy, number of reinterventions, and adverse events. Healing rates at 6 months were significantly shorter in group A (90%) than in group B (55%; P < .01). The time taken for cultures to become negative and duration of antibiotic therapy were also significantly (P < .05) shorter in group A than in group B, whereas the number of reinterventions was significantly higher in group B (P < .05). No difference was noted in the adverse events except that for reinfections, which were more frequent in group B than in group A (P < .01). DWC is as safe as and more effective than standard local antiseptics in the management of wide postsurgical lesions in the infected diabetic foot.
Re: Superoxidized solution for infected diabetic foot ulcers
Is anyone else currently using this product? Have just started using this, so am interested on what people make of this 'magic' water. So far i'm impressed......
Re: Superoxidized solution for infected diabetic foot ulcers
This is the product I just spoke of in my Introduction. It is amazing, and has dramatic results. You will find more data under the new name Microcyn, as Dermacyn is the old name (which information may still exist under). Would love to hear more feedback about what you have accomplished in your patient's care with the product!
Super-Oxidized Solution (SOS) Therapy for Infected Diabetic Foot Ulcers
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