Ladies and gents, it is such a pleasure to be with you today in beautiful, sunny Southern California, where even when it's not sunny, it's still sunny. I'm David Armstrong. I am a professor of surgery. And I direct our Southwestern Academic Limb Salvation Alliance, or SALSA, here at the University of Southern California. And we're going to try to cover the length and breadth of a topic that's often largely ignored, and that is what we call offloading the diabetic foot. Not offloading your problems, but literally offloading pressure. And that's the big idea. We're going to try to do this and have maybe a generation of research in the next give or take 20 to 30 minutes. And what we're going to be talking about as a family here is really what we would like to think of as pragmatic research that is really clinic-based, that's guided what we're doing. Hopefully a little of common sense married with a lot of this work. And it's going to kind of summarize all of the business into 10 basic questions that have led us to where we are now after the last maybe 20 or 30 years. And we're going to talk about not only removable types of offloading in the diabetic foot, but also irremovable versions of offloading. And that's really the big idea that we're going to talk about. So let's start with these 10 basic questions. The first one is this one. And what we know, or what we think we know, is that the gold standard device in offloading the diabetic foot is the total contact cast, or TCC. In myriad collaborations and guidance documents and various types of advisories, documents, most of which we've participated in, it has been defined as the gold standard. There are myriad randomized controlled trials that support this. We're going to look at some of those things in a minute. The trouble with this gold standard is, unfortunately, it is not so golden. And people don't use the total contact cast. Let me just show you. Look at these data. In this study, which is already almost two decades old, but it has been copied now by a number of colleagues over the last 20 years, this was the first one to do it, we looked at more than 900 diabetic foot specialty units across the United States, fewer than 2% used this supposed gold standard as the main method of offloading. They also used other things, like a person's regular shoes. We're going to look at whether that's a good idea or a bad idea in a minute. They used non-weight bearing and also removable cast walkers as well. These data have been emulated in other studies. You see these data from colleagues in Australia, and what you see is maybe slightly better than what you saw a few years earlier in the United States, but still not much better. Maybe only about 15% of them using the gold standard as the primary method of offloading in these patient populations. So that's the first point, is the total contact cast is the gold standard. The second one is most folks don't use it. And then the third point of 10 is in the lab, in the laboratory, depending on what country you're from, the removable cast walker, or RCW, offloads about as well as the total contact cast. Now this is pretty great, the removable cast walker. You saw some data already, but if you look here, these are data from my friend Larry Lavery, and Larry published this now pushing, I can't believe now, 30 years ago. And in this now, what is now classically a classic study, you see the TCC here seems to behave about as well as some of these other removable cast boots, like the DH walker or the Aircast, in offloading the bottom of the diabetic foot, depending on where you look. So that's pretty good news now, because people don't, while the total contact cast is the gold standard, people don't use the total contact cast, but now the big idea here is that you have this removable cast walker, which seems to offload about as well as the gold standard. That's good news, right? There's a but here. And the but is that in randomized controlled trials, the removable cast walker does not heal people as well as the total contact cast. So that makes us a little bit crestfallen. Check this out. So this is a study now from the early 2000s from our unit, and it's again been replicated, but this was the first one to do it. We looked at not only total contact cast, we also looked at the best available removable cast boot and also so-called half shoes. And it was worse than we thought. Folks were about twice as likely to heal at 12 weeks with a garden variety, non-infected, non-ischemic diabetic foot ulcer as they were in an Aircast, this removable cast walker or the half shoe. So that leads us now to say that the gold standard, which again is not so golden because it's not worn very much, unfortunately seems to heal people more consistently than its removable counterpart. So now the big question is why doesn't the removable cast walker heal people as well? It's as good in the lab as it is, as is the total contact cast, so it should heal people about as well, right? Well, sometimes common sense isn't so common, or at least common sense, sometimes research is proving the obvious, and let me just show you this. It's probably because people are removing their removable device. Removable cast walker is one-third of the name of the device, and it's probably two-thirds or even three-thirds of the problem. Check this out. This study showed us that it was even worse than we thought. In kind of the early days of what we now call wearables, we put a wearable device on a person's waist and then we actually hid one on the removable cast walker. Folks were only wearing, and we time-stamped them, and we synchronized them, and what we saw in this study, amazingly, was, again, worse than we thought. Folks were only wearing their removable cast walker. Now, these are people with wide-open wounds with neuropathy on the bottom of their diabetic feet. They were only wearing it for about 28% of their total visits, and their total time wearing. So about three-quarters of the time, give or take, they were not wearing their device. And we wonder why, when we use all these fancy modalities to try to heal these wounds, it doesn't work. And very often, it's because they're probably destroying it by walking on it. And so, if that's the case, and if one through six is true, if the gold standard's a TCC, but people don't wear it, there's this other device that offloads as well in the lab, but not in real life, why? Because they're removing it. Then maybe we can take this device that they're removing and make it irremovable. So point eight is enter the instant total contact cast, or ITCC. And this is a really, really simple idea. Let me tell you. It's simple. It might not be anything but simple if we thought of it, or if I thought of it personally. But you guys have already figured that out. So check this out. We simply take this device that offloads about as well as the total contact cast, and then we just render it irremovable. And you can do that with Coban, or cohesive bandage. And then, or if you're like me, you want to use some plaster and have some fun, you just use some plaster. You just wrap it with some plaster. So that's what we do. And this seems to behave remarkably about as well as a total contact cast, and significantly better in healing at 12 weeks than its removable counterpart. And there are additional data to show this in subsequent studies. In the middle of the last decade, you see here from my friend and colleague Bijan Najafi looking at rate of healing not only in this irremovable and removable version of itself. So all of this is great. All of these points. But you know, in many parts of the world where it's warmer, or where people can't afford a boot like that, maybe all of this research is for naught, but maybe we could take some of these ideas, the ideas of irremovability, the ideas of good quality offloading, and make it local, or even hyperlocal. And let me just show you some of these solutions. This is an example of a local solution. This is from my friend Shatish Shankar from Lucknow, India, in the northeast of India. And he has taken some of these ideas of irremovability, of cost-effective offloading, and kind of just made it work in his clinic for his patient. So check this out. Let me just show you this. And so this is a patient. It looks like he or she still has a ring on their toe. I hope that doesn't cause a stricture there. You can tell he is not a surgeon. He's an endocrinologist. Just look at the way he holds that. It just makes me cringe holding that scalpel like that. So there's this wound under here. He does the variety pretty darn well. This neuropathic wound in this person with diabetes. So then he just takes some speaker foam and then just rolls it up. This is not even speaker foam. This is called rest-on foam. And it's very inexpensive. It's just pennies. And then you see him putting that behind the metatarsal head, so it's like a metatarsal bar back there. And then he just wraps it with some elastoplast. And then you see this person healing consistently with this neuropathic wound over the next few weeks. This is really great. There's other ways to do this. Let me take you from South Asia, from Lucknow. I'm going to take you to a conflict zone in Syria. This is our buddy Abdul Aziz doing this, believe it or not, in Damascus where he did not have a lot of materials, still does not. And you see here in this case, he just takes some open-celled foam, drills some holes in it to make it a little lighter. And it's hot. He wants to make it as light and inexpensive, but also pragmatic as possible. And he makes something irremovable in this patient population and just tapes that up. This seems to work in Syria. So that's an idea now, taking some data and making it hyper-local, kind of coming up with a solution. So that's kind of points one through eight. So what's point nine and point 10? Look, in the time we've been chatting together, in the last 10 minutes and 20 seconds, our population has changed before our eyes, or at least over the last generation. And now, the folks that we used to treat that were predominantly just neuropathic now have lived long enough, many of them, thank goodness, to get some ischemia. And now, many are neuro-ischemic. And that may make the way we offload patients a little more complicated, maybe then, or maybe not. But maybe we should discuss it. Maybe we should have a compromise. And let me just show you these data. These are data from not just Bijan Najafi, but Ryan Cruz. And you see that this is the worst-case scenario, just a pair of comfort shoes. But you compare that to all these other types of offloading devices. And this is the big, heavy one. But these ones are lighter and maybe might work better for someone who's a little more infirm or a little less active, and maybe for people that have some ischemia. Maybe you can make something that's removable. Then maybe you could counsel them and watch a wound trajectory, and a person with some neuropathy and neuro-ischemia, you could go on to do something with these patients and not to them. And that is the big idea in looking at some of these offloading devices, and just use something that's removable initially, and then move to something that's less removable as you need to. And that has really informed the International Working Group on the Diabetic Foot Guidelines. You can go online and grab these. Just Google that. Or you know what? You can ping me. We give away all of our slides. I'll put all my info at the end. And you can look at this. It would be cruel and maybe even unusual for me to go through one of these kinds of flow diagrams on offloading treatments. But suffice it to say that we, our colleagues in the International Working Group, have gone through all of these different scenarios and discussed methods to offload. If you have a non-planar also, well, that's great. You can use something that's removable because the person isn't going to be walking on it. You just need to protect it in a logical manner. But then for folks that have plantar wounds, you can, if there's an infection or ischemia present, well, you can try to treat that infection or that ischemia while you're using a non-removable, and even then move into removing a non-removable device. And then you can see this. It gives options each step of the way as you are addressing ischemia and as you are addressing infection. And then it also gives options to kind of move from a removable, excuse me, from an irremovable to a removable technology. For folks that have heel ulcers, well, you still probably want to use something that is knee-high and hopefully something that is irremovable as well because we, healing a plantar heel ulcer is complicated, but we probably need to use that irremovable concept just as we were previously. If the wound fails to heal externally by offloading them, then you have to start thinking about offloading them internally. That's the big idea. And that's where we want to maybe change the way the foot hits the ground, generally speaking, through some sort of reconstructive surgery, tendon balancing, osteotomies, or both. And that, but now let's kind of move on to where we are now and maybe we'll be moving toward the future. And, you know, there are actually maybe other therapies to offload this. This is just kind of a plussed up version of a total contact cast. Let me just show this because it's maybe a little bit easier to put on. Now, I was sort of a little bit skeptical about this device when it first came out. This is my friend, my longtime buddy, and his longtime nurse. And this is Jeff Jensen. And JJ was a residency mate of mine, super clever guy. And this is him putting on a total contact cast, but you see it's a roll-on total contact cast. And I did not think this was going to offload as well as a regular total contact cast, but I was wrong. This appears to do just that. And this could be something where you can apply it even faster than you do a total contact cast in more clinics. It's just a nice little product. This has been around now for a couple of decades, but something that maybe has some promise. We also move on. You could also, if you really want to get creative and go to the next level, and a person has enough stability and wherewithal to use it, you could even do better than a total contact cast. Check this out. You could use an old school boulder splint. This is an old school splint that actually was originally used for polio, and let me just show this to you. It actually has some little spikes that grab the plaster and then suspends the foot entirely within this construct, and it's relatively inexpensive, and if a person can take short enough strides, this can actually offload even better. It just moves up the cast wall rather than on the bottom of the foot. Just another way if you want to plus it up in this patient population. Now let's look at some other ideas, because there are so many ways to go about this. And again, this is easy to talk about in a slide presentation. It is hard to do in real life, but check it out. This is a favorite patient of ours, although I must tell you all of our patients are our favorites, but these guys are like family, and I was flogging this guy. I was not helping him. I had him in a total contact cast, but I thought he needed a little bit more. I ended up taking him into the operating room after he had a little infection and debrided him, but moved him out of a total contact cast into a VAC, a negative pressure wound therapy, but while I was doing that, we just gave him this knee walker, and check this thing out. It works really, really well. You see him now, I'm going to see if you can see this, just walking out of the clinic, and we're trying to keep him below the speed limit here, but look at that. This guy's in his 40s now, so he's not in his 80s. He has the upper extremity and lower extremity balance to do that, so why not go for something like this? Then, really, the next idea is if we do this from this knee walker, what if we could just make a wearable robot to do this? This is a thing, things that colleagues of ours have been working on just down the street. Aaron Ames' lab has been working on this for some time. Let me just show this to you because it's just awesome. You see this now. This product is loud, unfortunately, and the battery life is not as good as it could be, but it's getting better, and I can envisage a time when we have these kinds of concepts which could assist our patients in stability, even whilst they're healing, or even with new next generation types of ankle foot orthoses. I believe this to be something that is a when, not an if. So, continuing ... ... to move along this, though. We've just talked about a whole bunch of things, but what if we could do something with our patients and not to them? What if we could tell them, maybe, when they're wearing the device, tell them when they're not, tell them the danger's there, and give them this feedback? This has led to what we call the NIH Smart Boot Study, which is a really fun study where we're trying to give people devices that they like or they want to wear. Check this out. This is a boot that was designed by Mike DiTullio, and he designed the second and third generation Air Jordans, so it looks kind of cool in comparison to other ones. We attach onto it a gyroscope, an accelerometer, which also is attached to a smartwatch, and it gives people information about when they're wearing it and when they're not. You could say, Ms. Garcia or Mr. Jones, you know what? You've been wearing this device. That's a great job. Or, you know what? That device is not being worn. It looks like it's sitting next to your door, acting like a doorstop. Maybe we could do better. Doing something with that person and not to them is kind of where it's at, and that, we believe, is a really great way forward. What's exciting is this is catching the attention of a lot of people. We actually went to the Consumer Electronics Show, and this team now, kind of marrying all this stuff, ended up winning an award at CES a couple of few years ago, so this is now becoming a thing. In fact, speaking of a thing, we were flavor of the day with our colleagues at Microsoft. This is our unit at Rancho Dos Amigos, where we can mash up these prosthetics and orthotics, have great cloud computing that's giving people information, and maybe even with an AI-based sort of Sherpa giving people information that might help them move through the world a little bit better. Ladies and gents, I'll put this video in by request, and check this out. I travel a little bit, and this video really made me crack up, and I wanted to share it with you because it's rather telling. Look at this guy. He's just getting on the airplane, and when in doubt, force it. That's the old motto in surgery, and it looks like it's this guy's motto in overheads, but when I saw this, I started cracking up because just like me, this guy's just focusing on a little area and not on the big one. When he steps back, he feels like a dummy, and when I am looking after these patients, I kind of feel like this. I say to myself, that's not just him. That's me. It's me in clinic, not on an airplane, kind of focusing too much just on the foot and not about the rest of the body attached to the foot. Immediately, when I saw this video, after I stopped cracking up, I thought of this great quote, just like you, from Sir Dominic Corrigan, famously of Corrigan's Pulse. He said this. He said, the trouble with most doctors, and I believe just most people, is not that they don't know enough, but they don't see enough, and I think if we step back and we regard what we do, much of what we do in medicine, in surgery, in engineering, I think, is probably pretty good, but there's some things that collectively as a family, we could probably do a little bit better, and that's why it's the practice of medicine, the practice of surgery, and I think if we just use some of this common sense and marry it with just the fact of doing something with our patients and not to them, I think we can effect some really positive change, and in my little area, maybe we can keep a few more legs on a few more bodies, because I think that's what we all deserve, no matter what our health, no matter what our age, and ladies and gents, I just thank you so much, you've been terrific.

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