According to the Center for Disease Control and Prevention there were roughly 130,000 lower extremity amputations as a result of diabetes in 2016. This number is alarmingly high and these amputations are often the result of a diabetic foot ulcer. The CDC also reports that there are over 30 million people in the US alone who have diabetes. Additionally, around 12% of people with diabetes will develop a diabetic foot ulcer at some point in their lives. This makes treatment for these ulcers a pressing concern.
D’OXYVA Undergoes Pivotal Clinical Trials
Circularity Healthcare, the company behind D’OXYVA, has announced that it has successfully finalized a contract with the Professional Educational Research Institute (PERI) to begin a new clinical trial. This trial studies the use of D’OXYVA to help prevent amputations and treat diabetic foot ulcers at a significantly reduced cost as well as a significantly higher rate of efficacy.
PERI is a widely recognized global clinical research organization and they have studied the efficacy and safety of D’OXYVA at many of the top universities in the US. The intention of D’OXYVA in part is to help address the recent epidemic of diabetic foot ulcers which have been caused by long-lasting quarantines and stay at home orders in order to curb the coronavirus pandemic. D’OXYVA is manufactured by Circularity Healthcare and it is a painless and noninvasive transdermal delivery system which can be used in minutes. The system significantly improves blood perfusion, tissue oxygenation and wound healing even in conditions where standard treatment options have been unsuccessful.
Jennifer Boadilla-Perez the Senior Sales and Marketing Manager for Circularity Healthcare has stated that, “D’OXYVA’s pivotal human clinical trial for complete healing of diabetic foot ulcers has been approved by the Western Institutional Review Board (WIRB), the largest in the world, and will include over a dozen high profile research sites at top U.S. universities and clinics”. To add to this PERI’s CEO Dr. Charles M. Zelen has said that, “Thousands of competing products in the past nearly twenty-five years have failed in achieving what D’OXYVA® has obtained in terms of regulatory approvals, clinical safety and efficacy in the past seven years. This is truly a game-changing milestone, not just for the company itself, but the entire medical community and the world and a preliminary report with meaningful results is expected within 6 months from starting the pivotal trial,”
Diabetic foot ulcers are a significant wound complication which arises out of diabetes mellitus and they occur in 3-13% of all diabetes patients globally which means that they affect millions of people. Diabetic foot ulcers are caused by a large number of factors which include decreased physical activity and reduced blood circulation. Additionally, people with underlying health conditions such as diabetes are at an increased risk to suffer further health complications from the coronavirus. Healthcare workers have seen an increase in the occurrence of diabetic foot ulcers since the pandemic began. This represents a significant and persistent problem which poses great health and economic risks to both the patients who have them and the healthcare system overall. Treatments which are effective at combating diabetic foot ulcers and reducing recovery time are considered crucial to preventing the latest wound epidemic.
Circularity Healthcare is a burgeoning world leader in proprietary circulatory health and noninvasive delivery technologies. The company is committed to helping improve the quality of life for patients by developing, manufacturing and marketing medical products to consumers. The company specializes in groundbreaking noninvasive technologies that are affordable and portable for the purpose of transdermal delivery. Circularity Healthcare is currently pursuing regulatory approval for D’OXYVA. In addition to being able treat diabetic foot ulcers, the system can also assist in the treatment of cardiovascular and microcirculatory blood flow issues, as well as immune and autonomic nervous system disorders.
D’OXYVA is currently being studied by 18 of the best universities in the US to prove its efficacy as a treatment for diabetic foot ulcers and other circulatory conditions. There exists a high prevalence of these ulcers particularly as a result of stay at home orders which were necessary to curtail the spread of the coronavirus. The D’OXYVA treatment is non-invasive and painless and can significantly reduce or even eliminate the need for amputations. This drastically improves the quality of life for individuals who are living with diabetes and particularly for those who suffer from diabetic foot ulcers.