From wound to amputation: A physician explains why diabetic foot ulcers demand urgent attention

As more and more American patients develop diabetes, there are greater risks of diabetic foot ulcers.

The wounds already affect up to one-third of people living with diabetes For primary care physicians managing diabetic patients, the stakes are stark: Left untreated or referred too late, a small wound on a patient’s foot can progress to deep infection and, in the worst cases, amputation.

Ned Swanson, M.D., is a plastic and reconstructive surgeon and co-founder of PolarityBio, a biotech company developing SkinTE, a novel autologous wound treatment made from the patient’s own cells. In conversation with Medical Economics, he described the scope of the diabetic foot ulcer crisis, its devastating effect on patient quality of life, and what primary care physicians need to know about recognizing and referring patients before a manageable wound becomes a catastrophe.

This transcript has been edited for length and clarity.

Medical Economics: We have heard multiple studies and estimates about the increasing presence of diabetes in Americans. With diabetes, unfortunately, some patients do develop diabetic foot ulcers and other wounds. Can you describe the scope and scale of the problem of diabetic foot ulcers?

Ned Swanson, M.D.: It's a massive problem, not just in the U.S., but worldwide. The prevalence and severity of diabetes is on the rise with Americans aging and with comorbidities and other diseases on the rise, cardiovascular disease and obesity, there has been just a massive uptick in diabetes overall. Then within patients that have diabetes, up to a third of them make a foot ulcer within their lifetime, and that's something that develops further downstream of the initial diagnosis of diabetes. But to put it in perspective, there's about 1.6 million to 2 million diabetic foot ulcers in the U.S. every single year. You can expect 50 to 60% of those to get an infection, and potentially up to 20% can end up in amputation. I think one of the statistics that puts it even in a more alarming perspective is about every 30 seconds, a new diabetic foot ulcer forms, and every 3 1/2 minutes, a foot is amputated because of diabetes and diabetic foot ulcers. So it's an enormous problem. It's a very challenging problem to solve. It involves a lot of different pieces, beyond just the wound itself, and it's something that we have PolarityBio have chosen as the first wound type to try to tackle with our technology.

Related coverage: Healing from within: Biotech and the future of wound care

Medical Economics: You've spent time with patients who are dealing with some of these wounds. When you get to the level of a diabetic foot ulcer, maybe after that, an infection, maybe after that, amputation, what does that do to a patient's quality of life?

Ned Swanson, M.D.: It's extremely detrimental to their quality of life. A lot of these patients, at the point you're describing where they have a foot ulcer or they have an infection, they have an amputation, if you use quality of life scoring systems, they're already extremely low. They're almost at the bottom of all the quality of life scoring systems that you can test within patients. And that comes from a variety of different factors, and a lot of them could be surprising to you. Pain is one of them. Another big factor is the odor, the smell, the dressing changes, the office visits, the boots they have to wear on their feet. And then you can imagine, if you had an amputation on top of that, how much that could limit just your daily activities and normal life. So it runs the full gamut of issues. Our true goal is, can we stop that in its tracks before you get to those worst situations where you're really not able to do all the things that you are accustomed to doing.

Medical Economics: What drew you to this problem specifically, and what has been most challenging about trying to solve it?

Ned Swanson, M.D.: One of the things that drew me to this problem and the company or this problem is the massive unmet need. If you think about wounds overall, all the different wound types that occur, from trauma to burns to chronic wounds, diabetic foot ulcers, being within chronic wounds, this has to be the biggest and largest problem that we're facing, and that we highlighted in all the numbers and statistics. But when you actually get down to the wound type itself, just a single diabetic foot ulcer in a single patient, it's an extremely challenging problem to solve. It stems from a lot of issues well beyond the wound. The patient as a whole — you may look at the patient from top to bottom, all their comorbidities, all the things that could be contributing to poor wound healing. You have the foot applying pressure to the wound once it's formed, and those are all challenges you need to get around. To us, we wanted to try to tackle one of the biggest problems, and this is what drew us here. And there aren't a lot of great options either, so you're going to really try to tackle something head on and try to make a difference. It's one of the biggest problems, and a lot of the traditional reconstructive surgery options don't work that well for diabetic foot ulcers. You have a real big gap in an unmet need in this patient population, and it's something we wanted to start with. We hope to bring the technology to other wound types as well, but this is one that I think we could spend the rest of our careers trying to improve.

Medical Economics: What did I not ask about that you would like our audience to know?

Ned Swanson, M.D.: Especially with your audience being primary care, is their role within the whole process of diabetic foot ulcer care. I'm sure they're well aware. I'm sure they've encountered it, given its prevalence. But wound care is a hugely multidisciplinary field, and unfortunately, there is rarely a single place where a patient could get everything they need to give them the best result possible with the wound. Primary care is probably that the closest thing they have to that home, because outside of what treatment is specifically going on the wound, the most important thing is managing their diabetes, managing their comorbidities, making sure all these specialists are coordinated. That's something that can drive outcomes more than anything in the space. It's something primary care is hugely responsible for in these wound care patients.

And the other factor is how quickly these wounds can turn and become unmanageable. So having that good referral pattern to a wound care specialist, a podiatrist, the vascular surgeon, someone in the community that they feel like they can reach out to quickly, even if it's in the early stages. Once four weeks I've gone by of a wound that's when you start thinking about advanced treatments. So really that first or second week that patient needs to be getting seen by a wound-care specialist to be able to move quickly at that four week time point, if it's not progressing with healing. That's one thing that would be huge for your audience to understand, know, if they haven't encountered it before or don't have those referral patterns set up. It shouldn't be something that needs to be managed by a single practice, even within the wound care centers, there's multiple specialists involved, from infectious disease to vascular surgery to wound care and podiatry.