A study exploring the healing of diabetic skin ulcers using topical oxygen/ozone gas mixtures could not proceed to completion and was now abandoned, according to Ozonics International, LLC, a veteran-owned biotechnology company engaged in the research and development of ozone-based medical therapies. "This fully scientific study, a world-first in its scope, was to be performed in Egypt, recruiting the collaboration of U.S. and Egyptian experts," said Gerard Sunnen, MD, Ozonics president.
Egypt has a diabetic population estimated at 5 million. The prevalence of diabetes is rising rapidly in the Middle East. 20% of diabetics develop skin lesions such as leg ulcers, and 15% of those will eventually require amputation. In the U.S., out of 24 million diabetics about 80,000 undergo lower limb amputations yearly.
"Pilot research studies have shown that topical oxygen/ozone treatment can dramatically reduce these amputation numbers," Dr. Sunnen emphasized, adding, "The FDA has already approved topical oxygen for skin healing in diabetes and vascular conditions. This proprietary technology adds a natural element's remarkable antimicrobial properties to accelerate wound resolution. No other antimicrobial can claim such wide range of action against the entire spectrum of wound-invading bacterial and fungal families, nor claim such unwavering defense against bacterial resistance, the bane of all antibiotics."
Other reported unique features of ozone include its ability to neutralize wound bacterial and fungal toxins - well known to inhibit healing - and to enhance local circulation via the activation of nitric oxide, in biochemical pathways shared by drugs like sildenafil (Viagra).
The study, named "Safety and efficacy of ozone therapy in the treatment of diabetic skin ulcers: A randomized double blind controlled clinical study," was to be sponsored by the University of Cairo, and endorsed by the National Research Centre, Cairo, the Egyptian National Institute for Diabetes and Endocrinology, and the Egyptian National Cancer Institute.
"The New York State Department of Health (NYSDOH), despite its denials, has long shown adversity to complementary medicine and to ozone-based medical therapies in particular, and research initiatives have suffered. Another U.S. medical ozone company, for example, had to back off from its groundbreaking clinical investigations on hepatitis C and now focuses on ozone disinfection of hospitals. NYSDOH's interference has proven to be a potent deal breaker. Inhibition of medical ozone development, possibly motivated by commercial interests, is done by discouraging potential business partners from collaborating with U.S. - based medical ozone companies and by discrediting U.S. researchers and entrepreneurs. Germany, Italy, Japan and Russia are consequently now far ahead of the U.S. in the development of these forward-looking biotechnologies."
Dr. Sunnen concluded, "Let us hope that the abandonment of this study will only be temporary and that research avenues will unlock. Diabetics need not suffer the travails of protracted skin ulcer treatments, often experienced as interminable. Amputations devastate the body and often profoundly demoralize patients. Looking into the future, research in oxygen/ozone topical therapies will find applications in all manner of acute and chronic wound care, including diabetic and pressure ulcers, circulatory skin lesions, post-surgical wounds, and complex accident and war wounds."