Looking at the Policy and Care Management Challenges of Diabetic Foot Ulcers
The statistics are highly concerning: among the 34 million Americans living with diabetes, the set of challenges around diabetic foot ulcers (DFUs) is enormous. About 15 percent of diabetic patients have experienced foot ulcers; and of those who develop a foot ulcer, 6 percent will be hospitalized because of infection or some other ulcer-related complication. According to a June 2021 article in The Journal of Clinical Orthopaedics and Trauma entitled “The current burden of diabetic foot disease,” and authored by Michael Edmonds, Chris Manu, and Prashanth Vas, “Neuropathy and ischaemia are two great pathologies of the diabetic foot which lead to the characteristic features of foot ulceration (neuropathic and ischaemic) and Charcot neuroarthropathy. These can be complicated by infection and eventually may result in amputation (minor or major) and increased mortality. All of these features contribute to considerable clinical and economic burden. Peripheral nerves in the lower limbs are susceptible to different types of damage in patients with diabetes leading to distinctive syndromes. These include symmetrical sensory neuropathy associated with autonomic neuropathy, which advances gradually, and acutely painful neuropathies and mononeuropathies which have a rather acute presentation but usually recover. Ischaemia in the form of peripheral arterial disease is an important contributor to the burden of the diabetic foot. The incidence of atherosclerotic disease is raised in patients with diabetes and its natural history is accelerated.”
What’s more, the authors of that article note that “Diabetes causes severe and diffuse disease below-the knee. The lifetime risk of developing a diabetic foot ulcer is between 19 and 34 percent. Recurrence is common after initial healing; approximately 40 percent of patients have a recurrence within 1 year after ulcer healing, almost 60 percent within 3 years, and 65 percent within 5 years. Charcot neuroarthropathy is characterised by bone and joint destruction on the background of a neuropathy. Its prevalence in diabetes varies from 0.1 percent to 8 percent.” And, concerningly, “Infection develops in 50–60 percent of ulcers and is the principal pathology that damages diabetic feet. Approximately 20 percent of moderate or severe diabetic foot infections result in lower extremity amputations. The incidence of osteomyelitis is about 20 percent of diabetic foot ulcers.”
Meanwhile, a whitepaper entitled “Preventing the Catastrophic Diabetes Complications Hiding in Plain Sight: At-home Foot Temperature Monitoring for Diabetic Foot Ulcers Leaders To Positive Clinical & Financial Outcomes,” was published in May by leaders at the Cambridge, Mass.-based Podimetrics, a virtual care management and technology company, and published to the firm’s website. That whitepaper notes that “Diabetic foot ulcers (DFUs) have been proven to lead to devastating consequences for a vulnerable subset of the diabetes population, including high risk of lower extremity amputations. Amputations can have a cascading, catastrophic impact on mobility, quality of life, and mortality for members. Early detection of DFUs is key to amputation avoidance, but DFUs are difficult to identify before they present clinically — and once they do become visible, they are extremely challenging to heal due to poor circulation, infection, or neuropathy associated with diabetes. Despite the enormous human and financial cost, DFU prevention is often a blindspot in many comprehensive diabetes programs.”
Per that, “Two assessments were conducted to explore the impact of at-home foot temperature monitoring as part of a comprehensive care program — a long-standing best practice cited in three major diabetic foot clinical guidelines — in improving both clinical and financial outcomes. The findings of these two assessments, led by Mid-Atlantic Permanente Medical Group and Intermountain Healthcare, showed clear advantages of once-daily, at-home foot temperature monitoring using Podimetrics SmartMat™ technology. At-home temperature monitoring is an effective way to reduce the negative clinical and financial impact of DFUs, which lead to catastrophic lower extremity amputations,” the whitepaper adds. Monitoring for earlier detection — when integrated with patient-centered technology and personalized virtual care support — cost-effectively promotes greater patient engagement, while serving as an extension of support to a health plan’s care management team to affect positive outcomes.”
Recently, Healthcare Innovation Editor-in-Chief spoke with Podimetrics CEO Jon Bloom, M.D., about the healthcare policy and equity challenges of diabetic foot ulcers. Below are excerpts from that interview.
Tell me a bit about your background, and how you ended up creating a company focused on this challenging area of healthcare and patient wellness?
My background prior to Podimetrics is that I was a practicing anesthesiologist. And I was a medical director for Covidien in their monitoring division, which got sold to Medtronic. As an anesthesiologist, I spent whole days in the OR involved in amputations. It felt like Civil War medicine.
And you could tell there were such health literacy gaps; the patients didn’t truly understand what was happening to them. So we formed at a Hackathon at MIT. Five of us sat down at a table. David Linders, my CTO, was the one to set out the problem. The Hackathon took place on October 21-22, 2011.
How do you frame the problem clinically?
There are a couple of elements involved. The patient at risk of foot complications tends to be fairly complex. They’ve had diabetes for a long time. Neuropathy is advanced; poor blood flow; kidneys affected, often smokers. And they’re overwhelmed. This is the typical non-compliant patient. The diabetic foot problem is a surprisingly large problem. If you take the total cost of care of these nearly 5 million Americans, the cost is about one-third of diabetes and half that of cancer, but the mortality is twice that of cancer. And it’s disproportionately affecting our most vulnerable patients—Black communities in the South, Latin communities across the country—and rural communities. And we just find out about it too late. So can we make a simple-to-use system involving daily measurements, and a relationship with a nurse who can drive good care and determine the moment to reach out to the patient? It couldn’t just be a tech solution. How can you really help this patient through to prevention?
So two elements involved are poor patient education and low health literacy, then?
Often, when we care for these patients, they’ll use language from the community; and it’s hard to do good medical education. For example, I spent time in the Mississippi Delta late last year, and it’s the first time they’ve seen a vascular doc who can talk about what it’s doing to their bodies. And so we have to build accessible technologies—can they get the technology and readily build it into their lives, not just patients with good tech and health literacy; it needs to be universal.
One historical challenge has been, until recently, at least, the relatively passive acceptance in Black communities, of diabetes. That is of course, changing, and was connected to lack of access to healthcare until recent decades.
Diabetes affects every organ system in the body. And most people don’t have a full appreciation of that. And if you’ve been in a community that lacks full access to care, I can only imagine. And if you’re a Black American, your likelihood of amputation is four times higher than for a white patient. And if we can bring the provider more into the patient’s life, we can make a difference, so that we have you throughout the entire continuum.
How does the core solution work?
What we’re looking for is signs of early tissue breakdown. One of the first things the body will do is to respond to inflammation, in the form of a kind of localized fever. Our mat has a grid that provides a full thermogram of foot temperature in both feet. A study showed that in-home monitoring can detect 97 percent of the wounds that occurred, 37 days on average prior to presentation in an exam or where the patient found it. We used the moment when the patient saw it as an index for the study. On top of that then, the key piece is bringing in that nursing team—an alert is useless unless you can provide an intervention. The phrase we use is “offload” the patient. 15 percent reduction in step count. That allows the body’s blunted healing mechanism to catch up to the issue. And then after that reduction in step count.
And then we can initiate the intervention. A peer-reviewed outcomes study: our pilot with Kaiser Permanente. They have an amazing prevention system. And they had a strong presence in the Mid-Atlantic region. We found that we reduced amputations by 71 percent. It was a very high-risk population; to get into the trial, you had to have had a history of a diabetic foot complication in the prior 24 months. So the patient was still healing. And it never remodels back to a normal foot. As many as 60 percent of the patients will have another foot ulcer in the year following closure. 71 percent reduction. All hospitalizations reduced by 52 percent, all-cause ED visits by 40 percent, and all-cause outpatient visits by 26 percent.
What are some of the core care management aspects of diabetic foot ulcers and other issues?
One is that, for the patient who is overwhelmed, with health literacy and tech literacy gaps, there is hubris in thinking that simply putting technology into the population will move the needle. And the data I’ve seen supports that. We have to find ways to make sure our technologies are being used, and that the patients understand what’s happening. Just putting another app on the phone—patients aren’t necessarily engaging as they could. So we have to have care management involved. So care management for health plans—I actually believe very strongly in Medicare Advantage; and for our fee-for-service patients, the app can be helpful. But we can often help a care management program to be better. Can I give them quantifiable data, so that they can spend more time with particular patients who need more urgent care management? We help them to be more efficient.
What would you like clinicians to know? Until recently, the classic image was of an elderly lady, Mrs. Smith, who carried around a shopping bag filled with medications, and who basically had to do her own care management.
We’re so busy; there are new challenges facing us every day. We’re trying to keep up, we don’t have a lot of spare time. And if you ask us simply to do something “extra” that’s care-related, it will fail. So the work has to take place between visits. And as a patient, you have to meet me and come into my clinic. So technology creates a one-to-many-provider system. And so I get to you in a way that helps you. That’s the promise we’re offering.
Is there anything else that you’d like to add?
This patient is experiencing worries; prevention isn’t working for them. And they fear that diabetes can be the cause of their death. We can finally survey how they’re feeling about their providers, their care, their disease. We need as a healthcare system to do more work to develop a patient-centric approach.
