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Diabetic Foot Ulcers—A New Treatment That You Can Do At Home

New treatment using pure oxygen therapy that is applied at home appears effective in speeding up healing of diabetic-related foot ulcers and reducing recurrence.

with Robert G. Frykberg, DPM, David Armstrong, DPM, MD, PhD, and Mike Griffiths, DProf

If you have diabetes, developing a foot ulcer can be serious—deadly serious. These open sores occur in about 15 percent of those with diabetes, and most often appear on the bottom of the foot. About half of all people who experience a foot ulcer will land in the hospital due to either an infection or another complication related to the foot ulcer.1

Regular self-checks are essential to reduce the risk of diabetic foot ulcers.If you have diabetes, regular foot checks by you and your doctors is essential to catch any foot sores before they develop into hard to manage foot ulcers. Photo: iStock

Of course, this open, slow-to-heal wound is likely to restrict your mobility and make life pretty unbearable and depressing, especially if, as is common, an infection sets in, or is worsened by poor circulation. And, the standard treatments, ranging from compression stockings to are not sufficiently effective.

Now, there may be a home-based method of oxygen therapy that is reported to help—both to heal the ulcers faster than usual care and to help keep them from recurring.2. 

"This approach delivers pure oxygen directly to the surface of the wound," says Robert G. Frykberg, DPM, the study's lead author and an adjunct professor at Midwestern University in Glendale, Arizona.  The best aspect of this new treatment is that it can be done by the patient at home, which is a huge bonus, he tells EndocrineWeb.

New Wound Therapy—Topical Pure Oxygen–Appears Effective in Healing Food Ulcers

Investigators from Midwestern University invited 73 people who had diabetes, both type 1 and 2, to participate in a study to test this new treatment for diabetic foot ulcers.

They found that nearly 42% of those who were randomly assigned to receive the oxygen therapy experienced significant symptom relief, compared to just 13.5% of those who were “treated” with regular room air (ie, sham or placebo) for 12 weeks.2

This new food ulcer therapy is called TWO2 for Topical Wound Oxygen home care therapy. The treatment involves placing an inflatable chamber, similar to a large stocking, over the wound, and then an oxygen generator fills the chamber with pure oxygen administered under pressure.2

As a result of the oxygen therapy, Dr. Frykberg says, "it stimulates production of collagen, growth factor, new blood vessels and increased ability to fight infection."

Oxygen has long been viewed as crucial in the wound-healing process,3-7 the researchers say.  For years, hyperbaric oxygen therapy has been studied intensely to heal foot ulcers and prevent amputation. But results remain inconsistent, the researchers say.

However, Dr. Frykberg and his colleagues say that the use of topically administered oxygen therapy has been hampered by studies that weren't well designed and complicated by results that were inconsistent.8-10

Our study, however, has more ''robust data'' than that for hyperbaric treatment, says Dr. Frykberg. The home-based treatment fulfills an important need—of convenience—which remove the requirement of having to travel to a clinic to use a hyperbaric chamber, and also remove the challenge faced by individuals who experience claustrophobia or other issues that making it hard to use this mode of therapy.  

The at-home treatment must be applied for 90 minutes, five times a week, he says. During the treatment, a patient can watch TV, read, do work on the computer—pretty much any quiet activity. The only limitation is that smokers must refrain from smoking as a matter of safety (ie, to avoid the risk of combustion).

Understanding How the Oxygen Study Was Conducted

To be included in the study, patients had to be diagnosed diabetes and have a non-healing, full-thickness foot wound. These individuals had to meet the standard classification, known as the University of Texas Classification (UTC) grade 1 or 2 diabetic foot ulcer, measuring more than 0.39 of an inch but less than 7.8 inches after surgical removal of unhealthy tissue (debridement).2  On average, patients were in their 60th decade of life.

These patients had had food ulcers for as little as a month and lasting up to one year, and they had been receiving the standard care during this time. According to the American Podiatric Medical Association, several factors are key in the typical management of foot ulcers, such as preventing infection, taking pressure off the area ("off-loading"), removing dead skin and tissue ("debridement"), topical medications or dressings, as well as assuring that patient is under care for blood glucose management and related health issues.1

After three months of treatment, 15 of the wounds that were present at the beginning of the study (41.7% of noted foot ulcers) were completely healed in the group getting active oxygen therapy but only 5 wounds, or 13.5%, in the group receiving no treatment (placebo).

Put another way, those receiving the pure oxygen were 4.5 times more likely to have their foot ulcer heal. After the researchers took into account the severity of the ulcers, the patients on the oxygen showed even greater improvement—6 times more likely to completely heal—over the 12 weeks.

Dr. Frykberg and his team reviewed the progress of the treated ulcers again after one full year, and these hard-to-treat wounds stayed healed. Only one of the 15 healed ulcers in the oxygen group came back, while two of the 5 sores that healed after three months in the placebo group returned. That result was not considered significant from a statistics standpoint, the researcher says, but is still considered of benefit to patients.2

Besides wound healing, the researchers reported that those receiving the pure oxygen therapy reported better overall well-being, and improvement in their quality of life. Also, there was good news in that no one exoerpience negative side effects as a result of using the oxygen therapy. Yet, two patients in the treated group, and 3 people in the placebo arm, underwent limb amputation.2

Self-Treatment with Pure Oxygen Therapy Appears Beneficial for Diabetic Wounds

"I would call the data from this study pleasantly surprising," says David Armstrong, DPM, MD, PhD, who is a professor of surgery at the Keck School of Medicine at the University of Southern California and director of the Southwestern Academic Limb Salvage Alliance (SALSA) in Los Angeles. He was not involved in the study but reviewed the findings.

The study was scientifically done, he says. And, the new findings suggest that the science behind the treatment is becoming more convincing. While this technology has been around for many years, it is only recently that more robust studies have been conducted to support the use and effectiveness of the use of pure oxygen, specifically delivered in the comfort of the patient’s home.

"It looks like the data support that topical oxygen may be a good adjunct to improve wound healing," he tells EndocrineWeb. "It is not going to be a primary means of therapy, which still depends on quality surgical debridement and foot protection, and improved limb circulation. But once we have done all of these things, this technology looks like it could be quite helpful" in supporting continued healing and possibly lessen the rate of recurrence of these foot ulcers.

Insurance Coverage for Pure Oxygen Treatment Is Limited but Expanding

The Food and Drug Administration considers the oxygen delivery product, a class II medical device, to which it granted premarketing clearance in 2009.

The therapy is available now in limited areas of the country but the company is working to gain broader availability, says Mike Griffiths, DProf, CEO and medical director of AOTI Inc. based in Oceanside, California, and Galway, Ireland.

This therapy is now prescribed in Veterans Administration facilities, he says, and ''we have approval for New York State Medicaid reimbursement." He declined to provide the cost to a patient who doesn’t have insurance coverage, but he says the new study results is expected to help the company get broader healthcare coverage from Medicare and other insurers soon.

Treatment Still Requires Regular and Ongoing Foot Self-Care: Tips to Reduce Food Ulcer Riak

The best treatment for a foot ulcer, according to the American Podiatric Medical Association, ''is to prevent its development in the first place." To prevent diabetes-related foot wounds from occurrng, you should have your feet checked at least annually, and more often if you have poor circulation or other symptoms.

Besides seeing your endocrinologist or a podiatrist regularly, you can reduce your risk by assessing your time-in-range and making adjusting to improve your blood sugar control, quiting if you are still smoking, and taking the necessary steps to achieve good blood cholesterol levels.

Ask your podiatrist about the best shoes to wear and how best to inspect your feet to spot problems early.

Dr. Armstrong has no relevant disclosures. Dr. Frykberg received AOTI research funds to conduct the study and has received speaking honoraria. The study was sponsored by AOTI, Inc. which makes the device.  

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