Every chronic disease brings with it fears and concerns, and peoplewith diabetes face an especially daunting possibility: infectionsthat 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 endovascularsurgery at Louisiana's Cardiovascular Institute of the South.
"Worldwide, there's an amputation every thirty seconds. The commondenominator is a foot infection. It's likely that the overall costsof infection in the global healthcare picture exceed $100 billion ayear."
Allie's institution comprises a dozen clinics that treat 200,000patients every year, many of them with diabetic ulcers. To avertamputations stemming from those ulcers, he has become an earlyadopter of a new technology that he considers "as important asanything that's come along." Called Microcyn, it consists of asouped-up water molecule with special properties that knock outsingle-cell organisms, including the antibiotic-resistant bacterianow proving lethal to many hospital patients.
It also flattensviruses, spores and fungi. Causing no harm to multi-cellularorganisms – all critters large and small – it is the first nontoxicanti-infective.
In Mexico, the first country to obtain the technology and give itregulatory approval, physicians at diabetic foot treatment centerswere initially skeptical. Soon, however, says Dr. Andres Gutierrezof the National Institute of Rehabilitation in Mexico City (and nowmedical director for Oculus), "doctors using the product noticed thehorrific smell of diabetic wounds was gone." The stench of decayingflesh had been caused by bacteria, which the Microcyn solutiondestroyed. The physicians' next discovery was that infected woundsthat had resisted healing for a decade or more were rapidly closingwith the creation of new skin tissue.
Similar results have been achieved in Italy and in India, whichleads the world in diabetes with over 37 million patients. Dr. AmarPal Singh Suri, who owns the Diabetic Foot Care Clinic in Delhi,India, says, "Every year, diabetics in my country suffer a millionfoot or lower leg amputations." Personal tragedy aside, "saving afoot is a fourth the cost of amputation and an artificial limb." Dr.Suri began experimenting with Microcyn after learning of it at aconference in Germany. Trying it on a severe necrotic wound of apatient whose only remaining option was amputation, Dr. Suri wassurprised to see rapid improvement and the growth of healthy skintissue. "I shifted my other patients onto Microcyn treatment," saysDr. Suri, "with very good results."
The California biotech company that created the solution, OculusInnovative Sciences, was founded and remains led by Hoji Alimi. Hehas shepherded the technology a long way since its rudiments wereborn in a Japanese physicist's efforts to decontaminate coolingpipes in nuclear reactors. The solution is created by adding salt topurified water and then using a multi-chamber electrolysis processthat bumps an oxygen electron out of its orbit. The result is a formof highly oxygenated water that looks and smells like water, but iselectrically imbalanced, or ionized.
When single-celled organisms are bathed in the ionized solution, theoxygen atoms act as electron thieves: in an attempt to balancethemselves electrically, they enter the cell to raid it forelectrons. This fractures the cell membrane, allowing the organism'sinnards to leak out. "What the solution does," says Alimi, "issurround the single-celled organism…and basically shock the cell'smembrane…Because multi-cellular organisms are tightly bound,preventing the solution from surrounding the cells, there is noshock to the cell membrane and no negative impact.
The technology isas safe as saline [for multi-celled organisms], but makes short workof antibiotic-resistant bacteria such as methicillin-resistantStaphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus(VRE), with record kill times." Because bacteria cannot developresistance to an ionic assault, it's likely to continue to beeffective even against such tough customers.
Microcyn has only about 1/300th the hypochlorite ion concentrationof bleach, though it's been found to destroy ten bleach-resistantstrains of bacteria. If a child accidentally ingests the solution,the result is simply a case of clean teeth. There are no disposalproblems, nor any irritation either to hands washed with thesolution 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. Beyondcreating a ph-neutral solution, the Oculus innovations include atechnique that keeps the ions regenerating, providing a shelf lifeof a year. This shelf life is a critical advance, as manufacturingthe solution on site is out of reach for most facilities.
Microcyn technology has been approved for use in Europe, India, andMexico, and it's received limited FDA and Canadian approvals that sofar include moistening, cleansing, debriding, and lubricating woundsand cuts. Among trials in the works, Alimi says that Phase IItrials are being initiated at fifteen sites in the U.S. fortreatment of diabetic foot infections, comparing topical use of histechnology to oral antibiotics. Results should be announced inSeptember, and a Phase III study is planned for early next year.
Regarding use of Microcyn in the U.S. at this point, Dr. NeilScheffler, DPM, FACFAS, stated, "My only concern would be that thosewith current wounds may try to get this product from another countryand treat themselves. That would be okay if, indeed, it does whatthe company says it does. I'd like to see the studies done herefirst. In fact I'd love to be one of their study sites! I havelots of patients that could benefit from this product."
Physicians in other specialties have already found the solutioneffective. Dr. Ariel Miranda, a plastic and reconstructive surgeonand chief of the pediatric burn center at the Guadalajara CivilHospital, sought out the solution to see what it might do forchildren with third degree burns. He found the pH-neutral productaccelerated healing and, of particular importance for children,"could be used without pain when addressing the critical early needof avoiding infection."
Dr. Miranda concluded that the technologyeffectively combats infection without using antibiotics. "In allgrades of burns, we were able to use Microcyn to heal the skin. Itheals in a manner requiring far fewer skin grafts, and far lessscarring."
Dr. Allie's and other physicians' accounts of their explorations ofthe 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.