D’OXYVA® improves dermal microcirculation and promotes wound healing in the diabetic foot

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Prof. Puruhito and colleagues have released the results of three observational trials showing that D’OXYVA® (Circularity Healthcare LLC), a deoxyhemoglobin vasodilator, improves vasodilation in the treatment of diabetic foot ulcers (DFUs), boosts dermal microcirculation, and helps in the healing process of DFUs.

D’OXYVA® is a validated circulatory and nerve stimulant. The system was used by Prof. Puruhito for CO₂ transdermal delivery, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system¹. This improved dermal microcirculation leads, in turn, to enhanced wound healing².

The American Diabetes Association standards of care for DFUs refer to microvascular complications and their treatment via improvements in microcirculation; therefore, Prof. Puruhito’s team set out to test CO₂ transdermal delivery via D’OXYVA® in their patients. They have been gathering data since 2015, which led to the following results.

During the course of a 5-day treatment, O₂ saturation increased in patients treated with transdermal CO₂ in comparison to controls (15 patients/group)³ over the whole measurement range (up to 120 minutes post application). Moreover, a consistent heart rate decrease was found in patients undergoing transdermal CO₂ treatment. Furthermore, the perfusion index (PI) showed an upwards tendency in the treatment group, whereas it remained stable for untreated controls. See figure 1.

Figure 1: Changes observed after a 5-day transdermal CO₂ treatment with D’OXYVA®. H1-H5: pre-treatment, 10, 30, 60, 90, and 120 minutes after; blue trace: control, orange trace: treatment. (A) Changes in O₂ saturation (B) Decrease in heart rate due to treatment (C) Masimo® measurements of PI.

In light of these results, Prof. Puruhito’s team performed extra measurements of transcutaneous carbon dioxide (TcPCO₂), O₂ saturation, and PI in the 15 patients treated with D’OXYVA® for transdermal CO₂ delivery³⁻⁵. This data show that the oxygen saturation reached almost 100% in some patients, whereas the TcPCO₂ remained relatively stable throughout the treatment time (120 minutes). For more detailed information, see figure 2.

Figure 2: Transcutaneous CO₂ pressure (TcPCO₂), O₂ saturation, and PI assessment in the 15 patients subjected to transdermal CO₂. (A) SENTEC TcPCO₂ measurements for all patients at various time points after D’OXYVA® application (pre-treatment, 5, 60, 90, and 120 minutes after) (B) O₂ saturation (C) PI.

Finally, Prof. Puruhito’s team demonstrated the positive effects of transdermal CO₂ delivery via D’OXYVA® on the healing of DFUs⁵ (fig. 3), proving the clinical potential of this intervention to improve the quality of life of people suffering from this common complication of diabetes.

In conclusion, the use of a D’OXYVA® device for transdermal CO₂ delivery improves the outcomes of DFUs by enhancing dermal microcirculation and increasing perfusion rates and tissue oxygenation, therefore assisting in the healing process of the ulcers typical of diabetes neuropathy.

About D’OXYVA
D’OXYVA® (deoxyhemoglobin vasodilator) is a novel, clinically validated blood flow and nerve stimulant for people suffering from neuropathy. In various clinical trials, D’OXYVA® has validated leading independent research results and demonstrated above-average results in improving a host of physiological functions.

Subjects suffering from high blood sugar have reported neuropathy pain relief minutes after D’OXYVA® was administered and long-term blood sugar level improvements after just a few weeks.

Rapid and gentle skin delivery (over-the-skin) with the D’OXYVA® lightweight, handheld device has prompted improvements in blood microcirculation or PI by 33%* on average in all participants. Lasting results have been measured at 5-60 minutes and up to 4 hours after a single 5-minute D’OXYVA® delivery on the skin surface without reduction in PI levels.⁶

About Prof. Puruhito
Ito Puruhito, MD is professor in the Department of Thoracic and Cardiovascular Surgery at Dr. Soetomo General Hospital as well as a senior lecturer in the Faculty of Medicine at Universitas Airlangga (Indonesia). From 2001 to 2016, he was the rector of the aforementioned university. Prof. Puruhito finished his medicine studies at Universitas Airlangga in 1967, and in 1972 he received a doctorate degree, graduating cum laude from Frederich-Alexander University (Erlangen-Nürnberg, Germany). In his native country, he developed the Department of Thoracic-Cardiovascular Surgery at his former university, Universitas Airlangga, Surabaya. In 1978, he co-founded the Indonesian Association of Thoracic, Cardiac and Vascular Surgery. Prof. Puruhito has authored numerous indexed research articles in Scopus, ISI-Thompson or PUBMED, and scientific presentations and written several books in Indonesian, English, and German. He acted as reviewer for peer-reviewed journals such as Medical Tribune, Annals of Thoracic and Cardiovascular Surgery, Asian Annals of Surgery, Medicinus, and many more Indonesian medical-surgical journals. Currently, apart from lecturing, Prof. Puruhito actively researches stem cells, cardiovascular medicine, and surgery at the Institute of Tropical Disease as well as some work in microcirculation. Further, he acts as coordinator of research affairs at the Department of TCV-Surgery at Dr. Soetomo General Hospital Surabaya. Since 2014, he has been the chairman of the Council of Research in the Ministry of Research Technology and Higher Education of the Republic of Indonesia.

About Circularity Healthcare, LLC
Circularity Healthcare, LLC, located in Los Angeles, CA, is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes, and licenses its patented and patent-pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D’OXYVA®. One of the main mechanisms underlying D’OXYVA’s science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products in large and small clinics and hospitals to help enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital, and patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com or http://doxyva.com; doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries, contact Circularity Customer Care at info(at)doxyva(dot)com, info(at)circularityhealthcare(dot)com, or by phone (toll free) at 1-855-5DOXYVA or 1-626-240-0956.

References:

1.    Rogers, L. C., Muller-Delp, J. M. & Mudde, T. A. Transdermal delivery of carbon dioxide boosts microcirculation in subjects with and without diabetes, Information summary for healthcare professionals. Circularity Healthcare, LLC
2.    Puruhito, I. et al. D’OXYVA® Medical Device, a Potentially Cost-Efficient and Safe Adjuvant Therapy for Diabetic Ulcers: A Pilot Study. J Vasc Surg (2019).
3.    Puruhito, I., Soebroto, H., Sembiring, Y. & Nur Rahmi, C. Observation of O2 Saturation after transdermal CO2 delivery using D’oxyva® apparatus.
4.    Jayarasti, K. & Puruhito, I. Preliminary study of measurement of TcPCO2 using SENTEC® device.
5.    Nur Rahmi, C. Pengaruh Pemberian Transdermal CO2 terhadap Output Perawatan Luka Kaki Diabetik Wagner I dan II. (2018).
6.    D`OXYVA Relief from neuropathic pain. D`OXYVA https://doxyva.com/complete-fast-advanced-painless-relief-from-neuropathic-pain/.

Forward-Looking Information
This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management’s expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

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Jennifer Boadilla
D'Oxyva
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