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D’OXYVA® improves dermal microcirculation and promotes wound healing in the diabetic foot (clinical trial update)

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

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.

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Published in PRWeb

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.

diabetic wound

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.

Figure 3 Wound healing after 5-day treatment with transdermal CO2 delivery via D’OXYVA® in cases of DFU Wagner-1 and Wagner-2

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 PROF. ITO PURUHITO

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

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 D’OXYVA

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

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

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Is Active-Aging the New Frontier for Healthcare Technology?

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

The number of Americans over age 60 is predicted to double by 2060 – bringing the total retirement-age population to 98 million people. The swell in this patient demographic has several implications for care delivery methods and the allocation of healthcare funds.

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Elderly patients are more likely to grapple with chronic illnesses like diabetes and receive long-term care in senior living communities or in hospices. Additionally, older patients – whether receiving care at home or in facilities – often struggle with depression and loneliness. New technologies in the field of active aging can help negate these emotions and improve quality of life.

We may be tempted to brush off elderly patient populations as inept at technology, but we shouldn’t be so quick to underestimate them. Americans aged 50 and older generate roughly $7.6 trillion annually in economic activity, and will only continue to grow. To capitalize on this expanding market, the “active-aging” industry has emerged. This market includes patient safety and smart technologies, as well as remote monitoring and fitness devices – and is expected to be worth $30 billion by 2022.

Healthcare technologies for older Americans

Proactively engaging older Americans in their own health and wellness through technology is one way to improve longevity and quality of life while allowing this population to remain independent and active as they age.

Remote monitoring devices

Remote monitoring devices are one of the most obvious high-profile solutions for tracking and improving the health and safety of geriatric patients. These technologies include a variety of healthcare devices – like wearables, glucose monitors, and pacemaker implants – that can be controlled through smartphone apps and send data directly to care providers.

Smart watches can empower elderly patients to set medication alerts and stay active. These devices also provide location-tracking capabilities for patients living with Alzheimer’s. While FitBit and Apple devices garner most of the spotlight—particularly when it comes to fitness tracking—there are a variety of applications for this type of technology.

Nectarine, for example, is a smart wristband that aims to improve care for geriatric patients. The wristband monitors everything from a wearer’s sleeping and eating patterns to detecting motion changes that may indicate a trip or fall and can notify a specified caregiver of changes in behavior patterns or in an emergency.

No area is off-limits for remote monitoring technologies – even the bathroom. Toi Labs is currently running clinical trials of TrueLoo toilet seats in senior living communities. These digital toilet seats contain sensors that detect who the user is, and scans waste to detect dehydration, urinary tract infections (UTIs), irritable bowel syndrome (IBS), C. diff, and other gastrointestinal and urinary issues.

Automated devices like these allow patients and providers to access real-time health information and stay ahead of potentially life-threatening changes in heart rate or blood sugar. These tools are particularly helpful for older Americans living alone, who may not have immediate access to assistance in an emergency.

Medical device market share by vendor installs

med-dev-market-share-vendor

Fig 1 Image taken from the DHC Visuals LOGIC platform within Definitive Healthcare’s product suite. The chart features the top 10 most-installed medical devices by vendor. Data accessed on Jan. 7, 2020.

Medical device market share by product installs

med-dev-market-share-product

Fig 2 Image taken from the DHC Visuals LOGIC platform within Definitive Healthcare’s product suite. The chart features the top 10 most-installed medical devices by product. Data accessed on Jan. 7, 2020.

Virtual reality

Virtual reality (VR) isn’t just for gaming anymore. Developers are using VR technology to help mitigate depression and feelings of isolation for geriatric patients living alone or in senior communities.

Specialists work with patients one-on-one or in groups, providing opportunities to relive positive experiences and make new connections with others living in the same community. VR programs like Rendever offer reminiscence therapy, which allows users to virtually revisit childhood homes and other important locations, and group experiences that let users digitally travel to locations all over the world.

Physical therapy treatments are also benefiting from VR technology. Neuro Rehab VR leverages machine-learning to customize activities and exercises to each patient’s recovery goals and current ability. This makes physical therapy more like a game, with trended scoring and metrics that encourage patient progress.

Smart home devices

Smart speakers and voice assistants like the Google Home and Amazon Echo have become more popular and widely accessible in recent years. These devices allow users to set timers, play music, control home lighting, and more – just by asking. Despite privacy concerns from skeptics, Americans continue to install smart speakers, video doorbells, smart thermostats, and other devices that make our lives easier by learning from our habits.

Elderly users and their caregivers can program smart speakers to set morning alarms and daily medication reminders, make phone calls to family members or emergency services – and respond to user questions (such as, “what’s today’s date?).

In 2018, the ElliQ from Intuition Robotics became the first social robot made specifically for older adults. The digital companion robot combines touch screen and voice assistant technologies that enable seniors to make video calls, set medication reminders, arrange appointments, and even play games.

Engaging elderly patients in healthcare

Older Americans are at a disadvantage when it comes to technology. Often, it is geared toward younger audiences that grew up with these devices or have had significant time to integrate them into daily life. To ensure that geriatric patients are able to use this technology effectively for personal health management, developers must create their devices with this audience in mind— with simple interfaces and clear instructions that require minimal training.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.