Some 30 million Americans – more than 9 percent of the population – have diabetes. The proportion of adults with diabetes increases with age, reaching a high of more than 25 percent among those ages 65 and older.
One common and debilitating side effect of diabetes is foot ulcers. They can be one of the more persistent and dangerous consequences of diabetes, a type of open sore that does not heal in a timely manner. On average, diabetic foot ulcers last 12 to 13 months and recur in more than half of patients, leading to loss of function and a decrease in quality of life. Chronic wounds such as these present a challenge to patients and healthcare professionals alike because of the high cost and intensity of care needed for treatment.
Because of the high costs of treatment, both to the healthcare system and the quality of life of patients, there has been growing interest and innovation in technologies to deal with the problem. The Food & Drug Administration recently gave its approval to market the DermaPACE System, the first shock wave device intended to treat diabetic foot ulcers. DermaPACE is a division of Sanuwave Health.
Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health said in a statement:
Diabetes is the leading cause of lower limb amputations. The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.
An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.
The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.
The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.
The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.
Another new piece of technology, the SugarPod, is now undergoing FDA review as a means of predicting foot ulcers with the use of a multi-function foot scanner. The SugarPod recently won the Alexa Diabetes Challenge, and creator Wellpepper received a $125,000 prize. We had a chance to chat with Wellpepper co-founder Anne Weller about what her breakthrough product can do:
It is a voice-powered scale and foot scanner. It can take your weight, it takes a picture of your feet, and puts those through a machine learning image classifier to look for any problems. That’s what it does today. The vision is it will also do sensing so we can look for hotspots sooner. Hotspots would indicate a potential infection so that’s even before there’s a visible lesion. And then we also plan to have it do some sort of Neuropathy test whether that’s with vibration or current or a filament. So those are the things it does as a scale and foot scanner but it can also be connected to an interactive care plan which is where the rest of WellPepper comes in.
When you have an interactive care plan, you have a number of activities or tasks you need to do in a day and the talking scale can ask you about some of those as well. It might ask whether you took your medication, may give you a quick tip. A quick tip might be education or a reminder usually based on your activity so it might be something about eating or exercise or just information about the disease you’re managing.
There are things we find might work well and integrate into your day. You’re standing on the scale, it asks you a question, you answer the question and boom you’ve got one of your tasks done. But then the broader interactive care plan could be on mobile device where you’re taking it with you during the day and it’s reminding you, you’re checking in, maybe taking pictures of your lunch so that you can track what you’re eating in a very non-intrusive way and you can send that through to a clinical person, a nutritionist, someone else in the office who’s going to look at that. We can also apply machine learning to those images and start to see trends over time.
The development of the SugarPod was an opportunity for Wellpepper that fit well with its overall mission of creating provider-initiated care and wellness plans for a variety of conditions in addition to diabetes. Weller told us why the company, which is basically a service provider, decided to move into a new realm:
We created it particularly for this challenge. We were adjusting to the requirements of the challenge: how do you help people newly diagnosed with type 2 diabetes, and we wanted to create something that would fit into the fabric of their day.
We’re not a device company so it was interesting for us to go down that path. However, once we have gone down that path, I think what we’re understanding is that there are two sides to it. One which is an amazing way to collect data to apply machine learning and to get insights and improve care and the benefits of that in the home. So not having to worry about making sure that somebody that needs a podiatric exam has an appointment. I’ve heard a lot from both patients and physicians about why those exams don’t happen.
And then also that the underlying technology doesn’t necessarily have to be used with that device, it can be used with other types of input. I don’t know that as a company we’re suddenly going to look at the next device or next device, but if you think about, again, exactly that conversation we were having, which is which things are able to be data collectors. So is that the cellphone? Which is what we’ve been relying on previously or is it a specialty device? Or as Amazon evolves, and Alexa and Echo, with video, does that become a data collection device and how does that connect someone back to their healthcare organization?
We have something: SugarPod. We’ve gotten incredible feedback from patients and caretakers and providers. So we have something there that we’re going to take forward. We think of it in the ecosystem of something we can use to help patients self-manage, collect information and connect them to healthcare professionals. I don’t know if that totally answers your questions but it really helps us think about a bigger vision and it’s a component of a bigger vision.
I asked Weller if SugarPod is going to require FDA approval:
It depends on how we deploy it. It depends on what it’s doing. We’re exploring options on how to bring it to market. The FDA has changed. They have definitely gotten better.
I noted that the FDA had been seven years behind in approving many new devices, and that’s now been cut down to two years, but Weller noted it’s not just the FDA:
The rest of healthcare is not all that caught up either. We were talking to someone about how an original smartphone diagnostic required that the phone be locked down because the FDA required that because if anything changed then it wasn’t technically the same device they had… You’re losing the benefit of having the phone if the phone can’t do anything else
Wellpepper is looking at a variety of means to bring the SugarPod to market:
We’re working on that. It’s been a bit of a whirlwind where we worked for the period of the Alexa challenge to get something together for the challenge and I have to say, the team exceeded I think all of our expectations on what we delivered for that both in that we have 98% ability to detect foot ulcers, so it actually works. And also the design that came together so we had people coming up to us at the challenge asking where they could buy it, patients.
So it looks like it’s further along than it is, but it is a prototype. So as we look at that, how we want to bring it to market, consumer vs. clinical, and then what to do in the regulatory state so I think we’ve got at least a year ahead of us and some of it will also depend on who we end up partnering with because we’ve had a lot of interest in either, do we look at strategic investors or do we look at more of a joint venture type partnership.
Wellpepper, as Weller noted, is not primarily a medical device company:
Wellpepper is a platform for interactive care plans. We empower people to follow and adhere to their care plans and to learn from their activities to help scale the care team on the other side. We’re really patient engagement.
If you look at how people are being given instruction today, being sent home with things to do, we’re just not even hitting the most basic of the usability and understandability. It’s usually paper. It’s usually written for clinicians and users and it provides no data back, no learning. Most of the time, people are outside the clinic and we’re missing really valuable opportunity to reach out and help them and connect them to a care team but also to collect data that can help improve both care and help the care team reach out if someone’s having a problem and prevent something like a readmission. We empower the patient, but in doing that, we can help improve care.
At the moment, Wellpepper is not available directly to consumers, only to providers, says Weller:
The reason for that, it’s threefold. We looked at things that were patient-only and a lot of what we know about the motivation that people get using our system is the fact that they know someone’s there to help them but they also know someone’s looking at it.
The other piece is that in order for the providers to feel that this data and this information that is coming back is useful, it has to be from them. When patients come in and they’re like ‘Hey look at my app,’ the provider doesn’t want to look at the app. They don’t know what it is or what it’s telling them to do.
So what we do, is we sell to the provider and we enable them to deploy their own instructions in this very actionable way where we get over 77% patient engagement. And then it helps empower the patients to self-manage and it has alerts and triggers so the provider can reach out if somebody needs help. When I say providers that’s someone in the provider office, not usually a physician.
At this point, Weller says her company has about 7500 patients and 1500 providers. And the focus goes well beyond diabetic care:
At the risk of sounding like we do everything and nothing, we have taken the approach that we can support any type of patient treatment plan. Our care plans are made up of building blocks and you can reuse them and put them together in different ways to make different types of care plans. and what we found is that there’s a lot of repeatabilities across service lines and care plans even though the specialist may not think so. When you go and sell to providers, especially in large health systems, they want one system that’s going to be able to go for each service line.
We started really in the physical rehabilitation medicine space but found that there’s repeatability across all these things so we’re continually adding building blocks to be able to support these scenarios. A care plan might be as simple as, say we’re doing pain management. It would be a pain scale, pain medication usage reporting and then it might be some physical activity. Now those might all be capabilities you’re going to find in a pre-imposed surgical care plan, and that might be a pre-imposed surgical care plan for knee replacement, hip replacement, spine, bariatric surgery, so that’s where we really are able to do the next one and the next one and the next one where diabetes, certainly diabetes is something that many health systems have been asking us for, but there’s a lot of repeatability between cardiac rehab and diabetes, things like diet and exercise, and medication.
The reality is that despite all of its broad programs, it’s going to be SugarPod that gets Wellpepper noticed. But as Anne Weller points out, right now it’s still a prototype without a pricing or distribution model in place. But watch this space