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Every chronic disease brings with it fears and concerns, and people with diabetes face an especially daunting possibility: infections that never heal, potentially ending in the loss of a lower limb.
"Every year there are 240,000 amputations in America and Europe," says Dr. David Allie, chief of cardiothoracic and endovascular surgery at Louisiana's Cardiovascular Institute of the South.
"Worldwide, there's an amputation every thirty seconds. The common denominator is a foot infection. It's likely that the overall costs of infection in the global healthcare picture exceed $100 billion a year."
Allie's institution comprises a dozen clinics that treat 200,000 patients every year, many of them with diabetic ulcers. To avert amputations stemming from those ulcers, he has become an early adopter of a new technology that he considers "as important as anything that's come along." Called Microcyn, it consists of a souped-up water molecule with special properties that knock out single-cell organisms, including the antibiotic-resistant bacteria now proving lethal to many hospital patients.
It also flattens viruses, spores and fungi. Causing no harm to multi-cellular organisms - all critters large and small - it is the first nontoxic anti-infective.
In Mexico, the first country to obtain the technology and give it regulatory approval, physicians at diabetic foot treatment centers were initially skeptical. Soon, however, says Dr. Andres Gutierrez of the National Institute of Rehabilitation in Mexico City (and now medical director for Oculus), "doctors using the product noticed the horrific smell of diabetic wounds was gone." The stench of decaying flesh had been caused by bacteria, which the Microcyn solution destroyed. The physicians' next discovery was that infected wounds that had resisted healing for a decade or more were rapidly closing with the creation of new skin tissue.
Similar results have been achieved in Italy and in India, which leads the world in diabetes with over 37 million patients. Dr. Amar Pal Singh Suri, who owns the Diabetic Foot Care Clinic in Delhi, India, says, "Every year, diabetics in my country suffer a million foot or lower leg amputations." Personal tragedy aside, "saving a foot is a fourth the cost of amputation and an artificial limb." Dr. Suri began experimenting with Microcyn after learning of it at a conference in Germany. Trying it on a severe necrotic wound of a patient whose only remaining option was amputation, Dr. Suri was surprised to see rapid improvement and the growth of healthy skin tissue. "I shifted my other patients onto Microcyn treatment," says Dr. Suri, "with very good results."
The California biotech company that created the solution, Oculus Innovative Sciences, was founded and remains led by Hoji Alimi. He has shepherded the technology a long way since its rudiments were born in a Japanese physicist's efforts to decontaminate cooling pipes in nuclear reactors. The solution is created by adding salt to purified water and then using a multi-chamber electrolysis process that bumps an oxygen electron out of its orbit. The result is a form of highly oxygenated water that looks and smells like water, but is electrically imbalanced, or ionized.
When single-celled organisms are bathed in the ionized solution, the oxygen atoms act as electron thieves: in an attempt to balance themselves electrically, they enter the cell to raid it for electrons. This fractures the cell membrane, allowing the organism's innards to leak out. "What the solution does," says Alimi, "is surround the single-celled organism…and basically shock the cell's membrane…Because multi-cellular organisms are tightly bound, preventing the solution from surrounding the cells, there is no shock to the cell membrane and no negative impact.
The technology is as safe as saline [for multi-celled organisms], but makes short work of antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), with record kill times." Because bacteria cannot develop resistance to an ionic assault, it's likely to continue to be effective even against such tough customers.
Microcyn has only about 1/300th the hypochlorite ion concentration of bleach, though it's been found to destroy ten bleach-resistant strains of bacteria. If a child accidentally ingests the solution, the result is simply a case of clean teeth. There are no disposal problems, nor any irritation either to hands washed with the solution or to treated tissue. The byproduct is simply water.
Various forms of super-oxygenated water have been around for awhile, but they usually last only hours and are highly irritating. Beyond creating a ph-neutral solution, the Oculus innovations include a technique that keeps the ions regenerating, providing a shelf life of a year. This shelf life is a critical advance, as manufacturing the solution on site is out of reach for most facilities.
Microcyn technology has been approved for use in Europe, India, and Mexico, and it's received limited FDA and Canadian approvals that so far include moistening, cleansing, debriding, and lubricating wounds and cuts. Among trials in the works, Alimi says that Phase II trials are being initiated at fifteen sites in the U.S. for treatment of diabetic foot infections, comparing topical use of his technology to oral antibiotics. Results should be announced in September, and a Phase III study is planned for early next year.
Regarding use of Microcyn in the U.S. at this point, Dr. Neil Scheffler, DPM, FACFAS, stated, "My only concern would be that those with current wounds may try to get this product from another country and treat themselves. That would be okay if, indeed, it does what the company says it does. I'd like to see the studies done here first. In fact I'd love to be one of their study sites! I have lots of patients that could benefit from this product."
Physicians in other specialties have already found the solution effective. Dr. Ariel Miranda, a plastic and reconstructive surgeon and chief of the pediatric burn center at the Guadalajara Civil Hospital, sought out the solution to see what it might do for children with third degree burns. He found the pH-neutral product accelerated healing and, of particular importance for children, "could be used without pain when addressing the critical early need of avoiding infection."
Dr. Miranda concluded that the technology effectively combats infection without using antibiotics. "In all grades of burns, we were able to use Microcyn to heal the skin. It heals in a manner requiring far fewer skin grafts, and far less scarring."
Dr. Allie's and other physicians' accounts of their explorations of the Microcyn solution may be seen in videos at http://www.oculusis.com/mexico/mp/video.php
A writer/photographer and recovering lawyer, Skip Kaltenheuser has been based in Washington, D.C., since 1979. (Remarkably, he remains un-indicted.) His work has appeared in well over a hundred publications worldwide, on topics including business, law, politics, and travel.
Jun 4, 2007
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.