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Circularity Healthcare Announces Expansion with Global CRO of Series of Successful Pivotal Human Clinical Trials to Study Use of D’OXYVA® for Rapid, Economical and Noninvasive Home Treatment of Diabetic Foot Ulcers (DFU)

PASADENA, Calif., Feb. 1, 2021 5:31 AM PST (MORNINGSTAR)

Addressing urgent and increased DFU problem related to pandemic lockdowns.

Circularity Healthcare announced it had successfully executed a contract with the Professional Educational Research Institute (PERI) in 2020 to immediately begin a new clinical trial to study the use of D’OXYVA® to help prevent amputations and treat human diabetic foot ulcers at one-tenth the time and cost, and at least five times the efficacy of competing modalities.

A widely recognized global clinical research organization (CRO), PERI will specifically study at multiple sites at prestigious U.S. universities the use of D’OXYVA® to help address the recent epidemic of DFUs occurring in diabetic patients due to long-term pandemic quarantines and stay-at-home orders. Manufactured by Circularity, D’OXYVA® is a painless, noninvasive transdermal delivery system used in minutes to significantly improve blood perfusion, tissue oxygenation, and wound healing even where standard treatments have failed.

“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,” said Senior Sales and Marketing Manager for Circularity, Jennifer Boadilla-Pelaez, RN. “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,” said Dr. Charles M. Zelen, PERI’s CEO.

DFUs are a major wound complication arising out of diabetes mellitus and occur in 3–13% of global diabetes patients, affecting millions of people. DFUs are caused by a variety of factors including decreased activity, diminished blood circulation, and people with underlying health conditions like diabetes are at higher risk for complications from COVID-19. Healthcare workers can expect to see far more instances of this persistent problem, especially with quarantine lockdowns, and it represents a significant health and economic risk to both patients and the overall healthcare system. Effective treatments that can reduce DFU recovery time, like D’OXYVA®, are absolutely crucial to combatting this newest wound epidemic.

About Circularity Healthcare LLC

Circularity Healthcare is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping improve quality of life by developing, manufacturing, and marketing medical, pharmaceutical, and consumer health products. Circularity specializes in groundbreaking noninvasive technologies for affordable and portable transdermal delivery systems, and is currently pursuing regulatory approval worldwide as a way of treating cardiovascular and microcirculatory blood flow issues, as well as immune and autonomic nervous system disorders. Learn more at: www.CircularityHealthcare.com.

About Professional Education and Research Institute, Inc.

PERI was established in 2005 as a premier CRO to manage Phase I – IV clinical trials around the world. PERI conducts clinical trials in both pharmaceutical and orthopedic research and performs specialty research in diabetic wound care, venous leg disease, neuropathy, peripheral vascular disease and gene therapy. One of the most unique advantages of choosing PERI as a partner in clinical trial management is a feature few CRO’s can match, which is our contracted sites throughout the United States, including IBC-certified sites. Learn more at: www.periedu.com

Media Contact:
Jennifer Boadilla-Pelaez
626-240-0956

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What You Need to Know About Non-Healing Wounds

Chronic wounds are wounds that do not heal in a normal amount of time. This delay in healing can be due to a number of factors. Read on to learn about the case of a 63-year-old female patient with a large chronic wound on her lower, left extremity that was resistant to healing.

Lena was a 63-year-old, White female who had developed a large, non-healing wound on her lower, right leg. She could not remember what had caused the lesion other than having dropped a heavy mirror on her right shin several weeks earlier. Lena had a past medical history of high blood pressure, diabetes, heart failure, liver failure, and blood clots in her legs. She had been a cigarette smoker for the last 50 years.

Lena’s physical examination showed a large, deep, non-healing wound on her right shin. Surgical treatment and debridement, along with antibiotic treatment, had failed to result in significant treatment. After 8 weeks of adjunctive application with deoxyhemoglobin vasodilator D’OXYVA[1], the chronic wound improved without any further complications.

Main Reasons Chronic Wounds Do Not Heal

Chronic wounds normally do not heal for a number of reasons, including[2]:

  • Increased age of the patient leading to slower healing time
  • Decreased functioning of the immune system due to illnesses or chronic disease processes
  • Decreased circulation due to diabetes affecting the peripheral vascular system
  • Decreased circulation due to peripheral vascular disease
  • Peripheral neuropathy leading to loss of sensation and the inability to feel wound and ulcer formation
  • Insufficiency of the venous system leading to pooling of blood in the extremities and resultant poor perfusion
  • Poor nutrition leading to decreased ability to heal wounds normally
  • Impaired mobility leading to impaired limb perfusion
  • Increased general stress levels leading to decreased wound healing
  • Decreased general health causing general debilitation and loss of normal healing ability

Variations of Chronic Wounds

There are several different variations of chronic wounds, including pressure ulcers, arterial and venous ulcers, and diabetic ulcers.

Pressure ulcers[3], such as “bed sores,” occur when an area of the skin is under constant pressure, often when a patient is confined to a bed or wheelchair.

This causes the skin to break down in areas such as the coccyx, heel, ankles, and dorsum of the foot.

Arterial ulcers[4] form when there is a blockage in an artery causing reduction in blood flow to the lower extremities and subsequent reduction in the supply of oxygen to the affected area.

Venous ulcers[5] occur when the valves within veins become damaged leading to pooling of blood in the veins and reduced blow flow and oxygenation to the extremities.

Diabetic ulcers occur when high blood sugar levels cause damage to the nerves, especially in the lower extremities.

This leads to numbness, causing the patient to ignore cuts or ulcers until they enlarge, often becoming infected.

Diabetes also depresses the immune system, leading to slowed healing.

Treatments for Chronic Non-Healing Wounds

There are a number of treatments for non-healing wounds [7]. These include:

  • Antibiotics to treat bacterial infections
  • Antifungals to treat fungal infections
  • Hyperbaric oxygen treatments to improve chronic wound healing
  • Surgical debridement to remove necrotic tissue
  • Specialty wrapping of chronic wounds
  • Skin grafting to close chronic wounds
  • D’OXYVA[8]skin delivery deoxyhemoglobin vasodilator as a wound solution to improve blood flow and oxygenation to chronic wound areas

HOW D’OXYVA CAN HELP?

D’OXYVA® (deoxyhemoglobin vasodilator) provides advanced, painless, complete and fast wound care solution. It has demonstrated speeding up diabetic wound improvement to an average of 5 weeks**.

In addition, D’OXYVA  improved quality of life such as sleep, appetite and mood in just a week in 100% of subjects. No adverse events of any kind were reported during, and years after the studies.

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Defects in Microcirculation and the Effect on Wound Healing: New Non-Invasive Treatments

The effects of defects in and poor functioning of the microcirculation on wound healing, especially in diabetic patients, can be devastating and life changing. As one particular example, Joseph L was a 63-year-old White male with a 24-year history of diabetes mellitus, hypertension, elevated cholesterol and arthritis. Joseph had been taking insulin for the past 12 years but his blood sugar levels were still poorly controlled.

On physical exam, Joseph had several very large, oozing and foul smelling deep ulcers located on the dorsum (top) of the left foot. After 8 weeks of intensive therapy utilizing the non-invasive D’OXYVA transdermal deoxyhemoglobin vasodilator, Joseph’s ulcers healed entirely and he avoided amputation of his left foot. Read on to learn more about this new non-invasive wound treatment that helps in wound healing.

 

What is the microcirculation?

The microcirculation refers to the smallest blood vessels in the body that supply oxygen to the tissues and remove waste products. This includes the arterioles, the venules and the capillaries. When the vessels of the microcirculation become damaged, it leads to decreased blood flow with lower oxygen blood levels and resultant damage to the skin resulting in a wound or ulcer.

Risk Factors for the Creation of Chronic Wounds

Patients with the following risk factors are at greater risk for non-healing wounds or ulcers (ulcers are the most common type of chronic wounds):

  • A history of decreased blood flow to a specific area (ischemia)

 

  • A history of uncontrolled diabetes (which leads to poor circulation, nerve damage and breakage of the skin)

 

  • A history of uncontrolled hypertension (high blood pressure)

 

  • A history of high cholesterol and atherosclerosis (cholesterol plaques in the arteries)

 

  • A history of blood clots (thrombosis)

 

Diabetic Foot Ulcers

Diabetic foot ulcers are a common complication of uncontrolled diabetes mellitus.1 Chronically elevated blood sugar levels damage the microcirculation of the lower extremities, which leads to ischemia and neuropathy (damage to the nerves). Diabetic patients often lose feeling in the feet and so are not aware of friction and pressure, which leads to breaks in the skin. This subsequently leads to open wounds that often do not heal over a 30 day period. These wounds can then become infected, leading to gangrene and eventual amputation.

 

An Example of a New Non-Invasive Treatment to Enhance Wound Healing

D’OXYVA is a non-invasive transdermal deoxyhemoglobin vasodilator that delivers FDA-approved ultra-purified CO2 molecules which diffuse through the skin leading to increased skin perfusion. In studies of the treatment of diabetic foot ulcers with D’OXYVA, increased diabetic wound healing was observed with wound closure often observed within 5 weeks.

 

Conclusion

Chronic conditions like uncontrolled diabetes and hypertension can cause damage to the microcirculation, which leads to delayed wound healing. New treatment methods like D’OXYVA deliver transdermal CO2-enhanced oxygen and nutrients to wound areas through the microcirculation. This speeds up wound healing and wound closure and helps avoid devastating complications such as amputations.

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Have you heard of Tere’s inspiring diabetic story?

“My Doctor told me I have less than a year to live if I won’t let them amputate my leg, but I didn’t let them . . . here’s how I am still alive now!”

 

When doctors initially told 60-year-old Theresa “Tere” Schaufer that she had diabetes, she went into denial for 20 years.

“I was diagnosed with diabetes 20 years ago, and only when my doctor told me that they needed to cut my leg, did I realize that my diabetes was serious,” she says.

A major contributing factor

“Doctors told me the only way to survive this fight was to amputate my leg,” Schaufer says.  

 

She acknowledges that she had lived an unhealthy lifestyle for many years. Working in a restaurant as a cashier, she did very little exercise, ate fast food and drank sodas on a regular basis.

“If the doctor tells you you’re a diabetic, don’t ignore it. You have to know why foot care is important for someone with diabetes. Don’t get to where I am. The sooner you accept things, the better it is for your health.”

Only after her doctor advised amputation did she realize the seriousness of her situation. Schaufer’s lifestyle had a hugely negative impact on controlling her diabetes

 

It was very painful!

Schaufer had puss from underneath her foot and necrotic toe. “After the doctor examined my foot, it was like decaying,” she says. “I couldn’t handle the pain. It was excruciating!” She was given less than a year to live because of her poor lifestyle.

 

I started to accept the situation.

Schaufer finally accepted her fate as a diabetic after the doctor told her that her leg would have to be amputated.

 

“I saw it coming. The pain was terrible. I could no longer handle it. At this point I was prepared; whatever came had to be.”

 

Unexpected turn of events

“I was browsing a support page I found on the web and read about a colleague’s experience with the microcirculation therapy she had tried. She noted that it had an amazing effect on her diabetic foot ulcer,” Schaufer says.

 

Right there on the support page, the woman raved, “There is this new technology you can buy online, D’OXYVA, which was voted one of the Top 10 Diabetes Care Solution Providers 2018! I didn’t have to amputate my leg because of this amazing product. In just four weeks, I can see my diabetic foot ulcer improving!”

 

“I read these words, and it gave me the hope I’d been praying for,” noted Schaufer.

She only had a month before her scheduled amputation, and without hesitation, she used the remaining days to try out D’OXYVA. She ordered the product online and closely collaborated with their in-house support.

 

“I was under D’OXYVA therapy for one month, taking it twice a day, once in the morning and once before bed as advised. It was very easy to use and non-invasive. In the first few days, I was skeptical as I wasn’t seeing any improvements, but I continued anyway and followed their suggested therapy guide,” Schaufer explains.

Thankful for D’OXYVA

When it was time for her to go back to her doctor and give her consent to amputate, her doctor was shocked to see her leg.

“What happened?” Those were the exact words my doctor asked upon seeing my leg after only a month. “Your wounds seemed to be healing from the inside,” my doctor said.

After a thorough check-up and the usual diagnostic check of my foot’s PI (perfusion index), he said the words that I never expected to hear. “We don’t need to amputate your leg anymore, but you need to continue whatever you’ve been doing for the past month.”

I then introduced him to D’OXYVA, and he was amazed by how this product had saved me.

 



Helping others

“I’m on my third month of D’OXYVA therapy, and it does amazing things for my health! I don’t think I have thanked D’OXYVA enough for this chance to live longer. I wouldn’t have the outlook on life that I have now,” Schaufer continues cheerfully. 
  

She is now also leading a healthy life. “This changed how I live my life, and I will continue sharing my experience as much as I can to help others.”

 

Schaufer often spends time with other “to-be-amputees” struggling to deal with their situation. “God gave me my situation to help others,” she maintains.

One of the ladies she counselled remarked how Schaufer had helped her tremendously. “She told me that I gave her her life back,” Schaufer says, breaking into tears.

“I’m in a way thankful for what I have been through with my diabetes because, without it, I wouldn’t have stumbled across my strength and my ability to help others.”

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Foot blood flow, polyneuropathy and foot ulceration in diabetes mellitus.

Corbin DO1, Young RJ, Morrison DC, Hoskins P, McDicken WN, Housley E, Clarke BF.
Peripheral Vascular Clinic, Royal Infirmary, Edinburgh, Scotland.


Comparable groups of diabetic patients asymptomatic of neuropathy (Group A), with chronic painful polyneuropathy (Group B) and painless polyneuropathy causing recurrent foot ulceration (Group C) were studied for differences in pedal blood flow, peripheral somatic and autonomic neuropathy and vascular calcification.

Blood flow abnormalities detected by doppler waveform analysis and consistent with reduced peripheral vascular resistance were found in all three diabetic patient groups. The abnormalities were of similar severity in Groups A and B but generally more marked in Group C. Test results of peripheral somatic nerve function became progressively more abnormal from Group A to Group C. Autonomic neuropathy was equally severe in Groups B and C, although mild abnormalities were recorded in diabetic patients asymptomatic of neuropathy.

A similar pattern was seen for vascular calcification in the tarsal and metatarsal arteries: marked in both neuropathic groups (B and C) but mild in Group A. It was concluded that abnormal blood flow consistent with reduced peripheral vascular resistance is very common in the feet of diabetic patients, whether or not they are symptomatic of neuropathy, and is most severe in those with chronic painless polyneuropathy and recurrent foot ulceration. No clear relationship was found between autonomic nerve dysfunction and the degree of blood flow abnormality.

HOW CAN D’OXYVA HELP?

Clinical studies with D’OXYVA®  (deoxyhemoglobin vasodilator) have shown extraordinary results for the role of transdermal noninvasive wound care and significant improvement of blood flow using ultra-purified, nontoxic, FDA-cleared molecules, such as CO2especially when all other approaches failed.

In an ongoing multiyear, multi-country, multicenter, randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA has demonstrated speeding up diabetic wound healing and ultimately wound closure to an average of 5 weeks**.