Business Solutions

Diabetic Foot Care: Stepping Forward

How can providers gain a foothold in diabetic foot care, and what path should those services follow into the future?

• By David Kopf
• Oct 01, 2010

There is an amputation performed every 30 seconds somewhere in the world as a result of diabetes. That is the sobering reality of diabetic foot care. The reason for this is that many diabetes patients, as a result of their condition, develop nerve damage that renders them insensate, and this often happens in their extremities, particularly their feet. This lack of sensation sets them up for severe foot ulcers that can result in tragedy.

“The reason that people with diabetes develop wounds is because they lose the gift of pain,” says Dr. David Armstrong, DPM, MD, Ph.D., Professor of Surgery and Director at the Southern Arizona Limb Salvage Alliance (SALSA) out of the University of Arizona College of Medicine. “So they develop neuropathy, and they wear a hole in their foot just as you might wear a hole in a shoe or sock. That hole is an ulcer, and that ulcer gets infected about half the time. Once that patient takes an antibiotic, there’s about a 20 percent chance they’re going to get part of their leg off.”

Some staggering statistics:

• Up to 25 percent of those with diabetes will develop a foot ulcer.
• More than half of all foot ulcers (wounds) will become infected, requiring hospitalization and one in five will require an amputation.
• After a major amputation, 50 percent of patients will have their other limb amputated within two years.

“The most common reason why someone with diabetes will end up in a hospital is not for a heart attack or a stroke, it’s for a foot problem,” says Armstrong, who also was a past chair of the Foot Care Council for the American Diabetes Association. “No one thinks about it, because it is generally silent. And one of the easiest things to do is to cut the thing off, but that is becoming less and less common.

“The great news is that at least eight in 10 of these amputations are preventable, and much of that starts at home,” he adds.

Enter the HME

Home medical equipment providers are in an excellent position to help diabetic patients manage their conditions, and one of the key ways they do this is through providing the appropriate footwear. The wrong shoes or socks “can be very damaging to the skin and cause wounds that are very difficult to heal,” says Ron Bar, Ph.D., president of Orthofeet Inc., which makes diabetic shoes and other foot care products.

Diabetic shoes differ greatly from regular footwear, because they must address various patient needs, Bar says. Some key features of diabetic shoes include:

• They must be loose fitting because excessive pressure might cause blisters or legions.
• The lining inside the shoes must be protective. Hard leather linings or seams can irritate the skin.
• They should have the right insole so that pressure on the sole of the foot must be evenly distributed.
• The outside of the shoes must be built to eliminate pressure points.

Also, patients should opt for soft, seamless, non-constricting socks, and the best color is white, as it will more quickly show if a sore has developed, Bar says.

In terms of recent developments in diabetic footwear, two key developments have come in the overall design of the shoe and the way it closes up, Bar says.

“We developed shoes that take into consideration all these specific issues, and on top of that we make the shoes with extra depth so that they can accommodate special insoles that are heat molded to the foot,” Bar says, adding that the extra depth means that the shoe can still provide all the necessary protection, while looking like a regular shoe. “The profile of the upper of a diabetic shoe can be very high and look cumbersome. So we made a special design where we hide the extra depth in the sole of the shoe so that they look normal and fashionable and the patient will feel comfortable wearing them.”

To help patients more easily don and doff their shoes, as well as to help keep the shoe loose fitting and non-binding, Orthofeet has developed a special “tieless” lace system that combines a lace and Velcro in such a way that it looks and functions like a lace-up shoe, but the final securing of the laces is accomplished with the Velcro.

Orthofeet Inc.’s “tieless” lace system lets diabetes patients who
find lacing up shoes difficult, but want the look of a lace-up shoe
the ability to secure tied laces with a well-camoflauged Velcro tab.

“It’s actually a laced shoe that doesn’t require tying,” Bar says. “This is very important for people who have difficulty bending over to tie laces.”

In terms of funding, diabetic foot wear is sometimes covered by Medicare. Medicare created a therapeutic shoe category to prevent foot problems and the ensuring cost, and those shoes are available to diabetic patients who are entitled to the benefit. However, not all diabetic patients are entitled. In order to qualify, Bar says patients must have diabetes mellitus and must meet one or more the following six conditions:

• History of partial or complete amputation of the foot.
• History of previous foot ulceration.
• History of pre-ulcerative callus.
• Peripheral neuropathy with evidence of callus formation.
• Foot deformity.
• Poor circulation.

If the patient meets those requirements, then he or she is annually entitled to one pair of shoes for up to $133 and three pairs of insoles for $54 per pair.

But even if the patient isn’t covered, diabetic footwear is not only absolutely necessary, but something that is somewhat affordable for the patient, given that the cost is slightly over what the price would be for a good-quality pair of shoes from the department store.

“Many patients who do not have Medicare are aware of the importance of protective footwear,” Bar says. “So many of them will buy it retail. But the main market is the one that is covered by Medicare.”

In terms of providing diabetic footwear, in most states a provider is required to employ staff with a shoe fitter certification. Staff can get the certification from a provider of the appropriate two day course, which is available from multiple education providers, both live and online. After they take the course, they must take an American Board of Certification exam and, assuming they pass, they then get the certification.

This certification allow that staff member to not only fit diabetic footwear, but also communicate knowledgeably with doctors providing the prescription and letter of necessity for the shoes and insoles.

Stepping Forward — A Focus on Prevention

“The goal of homecare is to keep people active, productive and independent,” Armstrong says. “And the way to do that is to provide patients health security, and if they can do more at home but be alerted when a danger is coming, then that is a heck of a lot better than being a long-term care facility.”

And if the patient is a Medicare patient, then any kind of institutional care, let alone an amputation, costs the taxpayer even more. This is leading to a situation that Armstrong describes as untenable. Already Arizona Medicaid cut preventative foot care, which represented only $1 million of an overall $8 billion Medicare budget.

“It was easy because someone could press delete on a spreadsheet, but the hue and cry over that was resounding,” Armstrong says. Suffice it to say that not just policy wonks understood cutting foot care would result not only in greater amputation danger for patients, but greater costs because of that danger.

And similar sentiments are being voiced at the Federal level. Toward the end of September, House Speaker Rep. Nancy Pelosi (D-Calif.) went on a media tour acclaiming the health-insurance rules that took effect last month, and her talking points featured health savings through prevention, especially when it comes to diabetes. “It’s about diet, not diabetes. It’s about prevention, not amputation,” Pelosi said in a recent National Public Radio interview.

So, the entire aim of diabetic foot care now is to prevent these wounds from happening.

Another development in treatment is trying to pair different healthcare professionals to leverage different knowledge bases that can more greatly impact patient outcomes.

“What we’re seeing now is really a ground swell of data and enthusiasm for treatment of the diabetic foot and prevention of amputation,” Armstrong says. “When you put teams together, different doctors and nurses and patient, that good things start to happen.

“Probably the optimal combination in the United States has been a very recent phenomenon and one that we coin the term ‘toe and flow,’ which is when you have a podiatrist and a vascular surgeon,” Armstrong continues. “That combination is really powerful, because what you can do is cover the length and breadth of the care of the diabetic foot medically and surgically. And you surround that with good overall medical care of the patient and nursing care and great things start to happen.”

As a result the ADA, the Society for Vascular Surgery and the American Podiatric Medical Association have formed alliances to spread this combined care approach, Armstrong says.

“This is a huge area of potential opportunity for companies that are in the DME and home medical area,” Armstrong says. “So much is moving in that direction, and for the first time in my career, it’s becoming evident that ultimately prevention is starting to pay.”

Next-Generation Education

Similarly, providers need to follow the physician communities efforts to raise the treatment bar in order to drive early detection and prevention of wounds by improving their own knowledge, says Dennis Clark, CPO, who heads the Orthotic and Prosthetic groups at the VGM Group. Clark argues that on-staff expertise at HMEs needs to go beyond current requirements.

“Now, many people that are treating diabetic patients for their foot care and shoes and inserts are pedorthists,” Clark says. “There is recognized training that is required and a required residency type of activity, and then national board exams to be credentialed as a certified pedorthist.”

During that education and residency, the staff member learns about the anatomy, biomechanics and pathomechanics of the foot, as well as the factors and comorbidities that put diabetic patients at risk, Clark says.

“Your education would cover all those things and help the care provider be prepared to address issues and think forward about the care and style of shoe and closure,” Clark says. “The training that is so essential for care the diabetic foot is available, there is a credential that is recognized, and I think those things are very important when you are going to be treating diabetic patients.

“The diabetic population is going to rise with the Baby Boomers and the need for quality care is going rise,” Clark continues. “We can effect not only the length of life patients have, but he quality of life, as well.”

Another benefit of pedorthist certification is that it contains an educational component so that the pedorthist can do things like show a patient how to conduct a self-examination, which is crucial in the prevention of any ulcers.

“We’re not with the patient every day, but the patient has the opportunity to look at their feet and do a daily evaluation,” Clark says. “Doing the self examination and acting when they think something is wrong is what we want.”

Next-Generation DME

This change in how physicians have set their sights on wound prevention has already impacted the DME space in terms of product. In addition to advances that have occurred in shoes and insoles for diabetic patients, new ways to detect wounds are being developed, and that could greatly impact the homecare sector, Armstrong says.

“There’s a real renaissance of attention on devices that are being developed now that will be available to patients,” Armstrong says. “Some of it will be self-pay and some of it will be insurance pay, but it will be a terrific opportunity for the enterprising person in home medical equipment businesses.”

A key development in this respect has been thermal imaging devices that can spot a wound well before a patient or physician would discover it through a manual search.

“A wound will heat up before it breaks down,” Armstrong says. “Generally speaking you identify infl ammation or a hot spot, and one of the devices is called a personal thermometer. Someone can “dose” their activity by checking their skin temperature just they dose their insulin by checking their glucose. These devices are becoming more accurate and more popular and patients are buying them themselves because they can log their skin temperatures.”

Companies offering such devices include Diabetica Solutions Inc., which offers the TempTouch infrared skin thermometer, and Visual Footcare Technologies, which makes the TempStat at-home temperature monitoring device. Looking somewhat like a standard bathroom scale, the patient steps on the TempStat, which creates a thermal image of the patient’s feet. The image allows for easy identification of areas of increased temperature where infl ammation and possible infection are present, so that the patient can take preventive measures before a break in the skin develops.

“That thermal imaging technology is already proven,” Clark says. “And it makes sense that people would use that technology after they have delivered the shoes and the inserts to make sure that the temperature is more uniform and those high-risk areas aren’t heating up. That would help us to do some kind of immediate evaluation on whether the insert is doing the job. You need to do it on the front, but let’s do it on the back end.”

Currently, work is being done to integrate these devices into items such as scales for the home so that patients can measure their skin temperature while they check their weight. Moreover, these scales could then be connected via WIFI to the Internet in order to send this information on to caregivers.

Next-Generation Services

And that exact scenario represents a tremendous opportunity for enterprising HME providers aiming to create the next generation of diabetic foot care services, Armstrong says. In the same way some sleep providers offer CPAP devices that can log patient activity and transmit it to physicians for review, an HME provider could create a service for diabetic patients and referral partners that regularly images and monitors diabetic patients’ foot temperatures and updates both patients and doctors if there is a possible issue.

Throw in an activity monitor, such as a pedometer, along with a call center, and the diabetic foot care provider could notice instance in which, for example, a patient has a hotspot on her foot and engaged in heavier than usual activity. The provider’s call center could then reach out to the patient, notify her of the situation, advise her to moderate her activity and that she should put on the right footwear, and set an appointment with her physician.

In that sense, providers could become a linchpin in the chain of next-generation diabetic foot care. Moreover that is the type of service that delivers an increased level of peace of mind and independence for which many patients would even be willing to pay out of pocket.

“That’s a game changer,” Armstrong says. “It’s a huge opportunity that right now very few people are thinking about. And there are prototype devices that we’ve been testing that do all this, and they’re not crazy expense. In fact they’re inexpensive — that’s what’s so wonderful.

“You can’t manage what you can’t measure,” Armstrong adds. “And better ways to measure things and quantify them and humanize them — and bring them to the patient — is the next great opportunity. And the devices that are becoming available are easy to use and that bodes really well for the future in this area.”

This article originally appeared in the October 2010 issue of HME Business.