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New Treatment can Halt the Troublesome Problem for People with Diabetic Foot Ulcers

Every day about 230 people in the United States will undergo amputation as a direct result of a diabetic foot ulcer.

That’s according to Dr. Foluso A. Fakorede, a cardiologist in Mississippi who specializes in internal medicine, in a column he published in The American Journal of Managed Care.

Fakorede notes that every 30 seconds throughout the globe a leg is amputated — and 85 percent of those amputations are the result of a diabetic foot ulcer that wasn’t successfully treated.

Research has found that people undergoing amputation are more often male, cigarette smokersTrusted Source, and people with kidney disease, diabetic neuropathy, peripheral artery disease, and hypertension. They’re an average of 64 years old.

A new type 2 diabetes diagnosis occurs every 17 seconds. And despite ongoing efforts to develop more effective diabetes medications to manage blood sugar levels, people with diabetes requiring amputation is rising — by 50 percent between 2009 and 2015.

Preventing amputation isn’t just about saving a leg. It’s also about saving a life due to a severe spike in death rates after amputation.

More than 50 percent of people with diabetes who undergo amputation will die within five years of the procedure.

However, there’s a promising new treatment in which a person’s skin cells are used to grow new skin.

If it continues to prove successful, the therapy could revolutionize treatment for problematic foot ulcers.

What is a diabetic foot ulcer?

A diabetic foot ulcer is usually seen in people with neuropathy, a condition that can cause severe damage to the peripheral nerves in the legs, feet, toes, fingers, and hands.

A diabetic foot ulcer can begin as something seemingly harmless: a simple cut or blister, or even a splinter.

People with neuropathy have varying degrees of numbness and loss of feeling in affected areas.

When you combine that loss of feeling with persistently high blood sugar levels, that simple cut or blister or splinter becomes ideal for the growth of bacteria and severe infection.

If a person can’t feel or easily see that area of their foot, the infection can worsen so that basic first aid (cleaning and antibacterial treatment) for the wound isn’t enough.

These wounds essentially fail to heal and close through the healthy growth of new cells and new skin.

Instead, they remain open, sometimes appearing like a gaping hole in the bottom of the foot.

The longer that ulcer remains unhealed, the more the infected area threatens the health of the entire leg.

Trying to prevent amputation

For a significant foot ulcer, total contact casting (TCC) is the next step.

The goal of TCC is to relieve pressure of the affected foot while walking but still ensuring it’s getting enough oxygen for successful healing.

This treatment method is effective for some people, but it falls short for many others and leaves them heading for amputation.

When successful, TCC can heal a severe ulcer in approximately 12 weeks. But if blood sugar levels aren’t successfully managed, the recurrence rate of that same ulcer or the development of a new one is nearly inevitable.

In fact, with a 60 percent likelihood of recurrence within three years, according to a 2017 study in the New England Journal of Medicine, healing with TCC can sometimes provide a false sense of safety from amputation.

The more severe the infection (the deeper and larger area it’s consumed on the foot), the less likely this “gold standard” of treatment is going to succeed.

When the ‘gold standard’ fails

The world of medical research has been aggressively working on finding more successful alternatives to TCC, but most haven’t proven to be nearly as effective.

Ozone therapy, for example, was found in a 2015 studyTrusted Source to be notably ineffective at healing diabetic foot ulcers.

Phototherapy, studied in 2017 in ChinaTrusted Source, was found to have a minimally effective benefit by slightly increasing the wound’s ability to heal.

Hyperbaric oxygen therapy, studied in 2017 in CanadaTrusted Source, proved ineffective but has had more positive results in other studies. It’s also considered too expensive and impractical for many people.

Promising new treatment

An ulcer struggling to heal is the body struggling in particular with one crucial detail: growing new skin cells to fully close the wound.

SkinTE is a treatment for foot ulcers that may be able to halt the rising amputation rates in people with diabetes.

Described as an “autologous, homologous human cellular and tissue-based product,” this treatment uses a sample of the person’s own skin to regenerate full-thickness, functional skin.

The skin grows, repairs, and reconstructs new skin over the ulcer, enabling complete wound closure.

“Essentially, if you just look at your hand and see a small little hair shaft coming out your skin, next to that hair shaft are certain cells,” explained Dr. Denver Lough, CEO of PolarityTE, the company that makes SkinTE. “And those cells represent every layer of your skin. By stimulating those cells, it can regenerate all of those structures and the skin itself.”

The process starts by obtaining a 1-square-centimeter sample of the patient’s skin from a healthy area of the body.

That sample is then manufactured, and within a day it’s applied to the person’s foot ulcer, where it will gradually grow and expand on the patient’s skin, closing the wound.

The results of the company’s first pilot study involved 11 people with diabetic foot ulcers. Each person had wounds resistant to standard wound care.

Ten of the 11 participants experienced total wound closure within 12 weeks after a single application of SkinTE. They also reported no adverse reactions, according to materials provided to Healthline by PolarityTE.

The 11th participant developed an unrelated infection during the study and was consequently unable to complete the 12-week period wearing SkinTE.

The results of the pilot study are being presented at the American Diabetes Association’s 79th annual Scientific Sessions conference in San Francisco this week.

One square centimeter of skin tissue taken from a patient can actually produce 2,000 square centimeters of new skin.

The problem with naturally healing foot ulcers, explains Lough, is that the end result isn’t strong, healthy skin.

“When they heal on their own, they don’t really heal; they create a scar or a pseudo-skin,” he told Healthline. “They don’t replace that defect with real skin. They replace it with a scar. SkinTE regenerates full, real skin. We haven’t seen it break down after it’s closed.”

Other technology, such as Purdue University’s customized insole to help treat foot ulcers, still relies on 12 straight weeks of treatment.

Results in real life

Dr. James Brian Warne, chief of the Podiatric Surgery Section at the Department of Veterans Affairs in Palo Alto, California, told Healthline he’s excited about the potential of SkinTE based on the results he’s seen in a small sample of patients in his practice.

“I was skeptical about SkinTE to start with because our patient population is older. They have so many other risk factors that I was concerned their skin would be too depleted of the cells needed for the process of SkinTE to work,” he said.

Considering the difficulty he was having using existing skin substitution products, Warne says he and his team didn’t hold back when they first began using SkinTE.

“We threw SkinTE on probably our most difficult wounds, and we’ve had complete success so far,” he said.

Warne emphasizes that the number of patients he’s used the product on so far is small, but the results have been inarguably impressive.

“One of the biggest things for me is that we keep using other skin substitutes and placing them on over and over and over again. And that presents a significant cost to taxpayers and patients,” he explained. “With SkinTE, we applied it once to each wound and instantly minimized the number of applications a patient needs, with positive results for the patient and cost savings for the system.”

Another physician says he’s found similar success.

“We started using SkinTE about three or four months ago on patients’ tougher wounds,” Dr. Steven Frania, a podiatrist from Foot & Ankle Specialists in Mentor, Ohio, told Healthline.

Frania’s specialty is limb salvage. Many of his patients are people with diabetes with severe foot ulcers who are trying to avoid amputation. Frania has used SkinTE on approximately a dozen people during the past few months.

“All of the foot ulcers healed with SkinTE, along with standard wound care, improvements in blood sugar levels, and taking weight off the affected foot as much as possible,” Frania said.

At first, Frania says he was worried about the process of harvesting a sample of skin, sending it off to the lab in Salt Lake City where SkinTE products are manufactured, and waiting for it to arrive safely.

But the process has worked seamlessly for his office so far.

“You get it back within about three days. We’ve never had an issue. And if we had, I probably wouldn’t use it on my patients,” he said.

Frania adds that the ability to use a patient’s own skin to regenerate their own skin is an amazing feat.

“In patients with diabetes where the healing process is impaired or a patient who is immunocompromised,” Frania said, “this treatment is the wave of the future.”

Cost and prevention

The cost of caring for lower extremity wounds in patients with diabetes is also a concern.

People with diabetes who have foot ulcers will find themselves at their doctor’s office an average of 14 times per year when following the standard treatment plan.

They also can be hospitalized once or twice a year, tallying up to $33,000 per year in healthcare costs, according to a 2011 studyTrus on Medicare patients.That study found that patients who’ve already undergone an amputation of their toe, foot, or leg will see annual healthcare costs at about $50,000.SkinTE is expected to cost much less, according to Lough.

Frania adds that SkinTE is also more easily covered by insurance because it’s a simple outpatient procedure and doesn’t require prior authorization like many other treatment methods.



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