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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Lee Rogers, DPM
Amputation Prevention Centers of America
White Plains, NY
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Lee Rogers has disclosed that he is a consultant for and receives financial or material support from KCI
So, let‘s welcome Lee Rogers.
Lee Rogers: I actually wasn’t stuck on the plane this morning, I got stuck last night and I spent the night in Dallas in the airport. And I don’t know if any of you seen what they have now in the airport, they’re called Minute Suites. And it’s like a little closet that you get to sleep in. So instead of sleeping in the chair, you can just go and rent a Minute Suite. I saw them in Japan when I was there once but now, we have them in Dallas, in Atlanta, and Philadelphia. And I think they’re opening in Chicago soon. So try it out. I feel well-rested. So, I’m going to talk about advanced wound care, when and why. These are my disclosures. And so, when you look at advanced care, it’s not only about products. I think a lot of it is about setting up an advanced algorithm for how to treat wounds and prevent amputations. And we talk a lot about the stairway to an amputation really to help us understand how somebody with diabetes ends up in the predicament of requiring an amputation. And then, we can backtrack and say what is it that we can do to prevent that from happening. So the first step is obviously the diagnosis of diabetes. But it’s not a single step from diabetes to an amputation. There are several steps that occur in between those two endpoints after that. About 8 to 12 years later, they develop peripheral sensory neuropathy that leads on failure. Repetitive trauma can cause an ulceration. The patients may or may not have peripheral artery disease, kind of depending upon your subpopulation. But it’s almost always the infection that is the coup de gras that leads to the amputation. So this allows us to kind of backtrack now. If this is the natural history of how somebody with diabetes would end in an amputation then we could say, what interventions can we do to prevent a patient from moving from one step to the next, and how in some cases can we even deescalate their risks. So, we’ve written about this a lot too, the six steps to prevent amputations. And the first three steps, they’re infection, vascular and pressure, offloading pressure. Larry Harkless talks about those a lot, called the VIPs of diabetic wound healing, vascular, infection and pressure. And then once you’ve managed the VIPs, you have a simple neuropathic wound that responds well to debridement, promoting granulation tissue, and then wound closure. So, our basic DFU pathway, this is the pathway that I kind of had in my mind every time I see a patient is, you know, you start with the DFU. If it’s infected then you follow the IDSA guidelines. If there’s ischemia, then you revascularize. Then you move down to the standard of care. That includes offloading, debridement then local care. You evaluate the effectiveness of that. If it’s effective, you continue the standard of care. If it’s ineffective, you move on to advanced care. And that’s really the summary pretty much of when to use advanced care and when not. And we’ll talk a little bit about some of those steps. So diabetic foot infections are primarily a clinical diagnoses. There’s not a single test you can order to diagnose an infection. This is completely relying upon your clinical acumen to determine whether or not there’s an infection present, swelling or edema, warmth, sometimes pain and then otherwise, painless foot. It’s important to classify this according to IDSA. And then infection always trumps vascular. If you’re considering what’s more important to a person who has an infection and gangrene, do I call the vascular surgeon or do I take him to surgery, the answer is always infection. And take care of that first then get vascular involved afterwards. There’s an appropriate way or the dos and don’ts of taking cultures in the foot. I’d encourage you to read this. This came from the IDSA guidelines, Lipsky’s paper in clinical infectious diseases. And also with ischemia, so that’s the next step down, we know that ischemia delays wound healing and it can lead to an amputation. So patients that have diabetic food ulcerations, they require some type of investigation for peripheral artery disease because it may not always be visible on the clinical exam that they have clinically significant PAD. And then, needed intervention should not be delayed. And that’s the thing that the mantra in our unit, you know, the thing that leads to more amputations is delay. And we try to get that out of the equation. A few papers won and this was by George Andros in 1984. So I was six, I remember reading it. And he talked about the need for arteriography in patients with gangrene and palpable foot pulses.
[05:02 And it just goes to show that you can’t rely on the foot pulses as a clinical exam as your sole indicator of whether or not there’s a good flow. I think the absence of foot pulses is a pretty good indicator that there’s poor flow. But the presence of foot pulses is not a good indicator of good flows. You have to move beyond that when you see a patient. There’s a couple of other studies too. This one from George Ha Van who Bob and I spent some time with in Paris not long ago, looked at the ABI and how it underestimates prevalence of PAD in people with diabetes and we knew that already. So your PAD exam, obviously your physical exam comes first and we can tell a lot by a physical exam, but it may not necessarily rule out entirely PAD. Then you have to move to your noninvasive studies. And there’s a lot of different studies that you could do as a noninvasive. And unfortunately, none of them have been pitted against one another. And so, it’s hard to determine which one would be better. The different circumstances are better. If you’re looking at a toe, you might use a different test. If it depends on what your hospital has available and sometimes what setting you’re in. So, there’s all sorts of things you can do as a noninvasive study. And then, any ischemic involvement needs to be seen by a vascular surgeon and they’ll often do something more invasive. One of the things that we use very frequently is skin perfusion pressure. I like this because you can get close to a toe, if not on the toe, and get the actual capillary pressure inside of the skin. And the capillary pressure comes in millimeters in mercury and there’s only one pressure. It’s not like blood pressure. We have a systolic and a diastolic. You only get one pressure of the flow going through the vessel. And there’s some pretty good interpretative guidelines on when somebody may have a problem with wound healing. The way it works is that a Laser Doppler is put underneath a cuff. And that cuff inflates through about 90 millimeters of mercury. And then that cuff slowly deflates over a couple of minutes. And the instant that that capillary bed, it’s exsanguinated when it’s inflated, the instant that it flushes with flow that the Laser Doppler picks it up and records it as the capillary perfusion pressure or skin perfusion pressure. So, we look at these and these guidelines are pretty good. There’s been some studies that have corroborated these. If you have a skin perfusion pressure lower than 30, you have a pretty unlikely chance that that wound is going to heal. If you have a skin perfusion pressure greater than 50, that shows that there’s no significant vascular impairment. There’s a big gray zone between 30 and 50 that requires some clinical skill and comfort level to determine what you’re going to do. But it’s a good way to quickly rule people in or then rule them out. Something else we’ve been using a lot and I saw them out here actually. And I don’t have anything to do with their company but I walked by their machine. The SPY imager or LUNA and this uses ICG green dye that you inject in any vein and you can use it in about 3 to 5 seconds. It goes from the heart, it gets into the periphery. And you use this laser camera which you see over the OR table there. And the laser will excite the dye and then you see it on the video screen where the dye is going. So you can use this as kind of a skin angiography to determine where any perfusion is getting. And that will help you determine the extent of debridement that you might need to perform. For example in this patient, he has a gangrene in the second toe. There’s some tracking gangrene that extends between the second toe and that fibronecrotic patch there in the arch. And I’m injecting anesthesia there. So you don’t really know what needs to be debrided. That didn’t show up. That video is not playing. All right, so we’ll skip it. Now, the video showed what needed to be debrided and I took a skin marker and drew around the edges. You know, the rest of it is not going to survive. So, after you pass kindergarten, you know they’re just cutting between the lines and then you remove what’s not viable. So then, we’re off to pressure unloading or offloading. And there’s lots of techniques that you can use, everything from total nonweight-bearing like bedrest, wheelchair or crutches or the rolling crutch. You have total contact casting which some call the gold standard.
[10:04] It may not really be the gold standard when it comes to what the standard of practice is because it’s not widely used although it is the best way to take pressure off. And then there are other devices that you can use. But the important thing is really to choose a device that is irremovable. And sorry about this, this video is not playing. I gave it on a jump drive for the first time. I usually play them directly from my Mac but they must not have copied over for some reason. And there’s a boot attachment that goes along with these devices and allows the patient to walk with this type. This is the TCC-EZ. Or you can do a traditional total contact cast. Or you can take a removable device and render it less removable as this one here. So, this is just an Aircast diabetic walker wrapped with Coban. So, debridement cannot be understated, the importance of debridement. This was an important paper that was just published on 312,000 wounds. They did this on Wednesday in Dr. Freiburg's clinic and got all those wounds. And what it showed was and I’ll point this out to you. So here, you look at the percent of wounds that have healed. This is the time of the healing here. And you can see here, this is the frequency of debridement. So the dark color, the dark blue is frequency less than one week. So, patients that were debrided more frequently than one time a week. These are patients that were debrided between every one or two weeks. These are patients that are debrided longer than every two. And what you can see here is that the wounds have healed more rapidly, the ones that healed in less than three weeks, a greater percentage of them had more frequent debridements. And you can see that that kind of fall down here along this. And you could see that the wounds that took longer to heal had greater intervals in between their debridements. So, it’s a good example of an illustration of why you need to debride. There’s different types of debridement that you can do. This is ultrasonic debridement using sonics and it’s a contact ultrasound and helps to remove tissue. It does a good job of wound bed preparation which we talked about before you’re going to use some advanced products so here’s a plantar heel ulceration and you can see something like this is not ready to have any type of graft or product put on it with the fibrosis and the hyperkeratotic tissue surrounding it. But just after one debridement with ultrasound, you can get it to a nice clean healthy wound base. Then it’s always important to reevaluate your progress and knowing whether or not you’re going to jump to something else or a more advanced product. This is a well-known paper done by Peter Sheehan. And what he showed here was that 90% of wounds that did not reduced by 50% area in four weeks, they were unhealed at 12 weeks. So if you don’t have your wound reducing by at least 50% over four weeks, it has a 91% chance that it’s not going to heal in 12 weeks. Similar paper came out looking at wounds and found that wounds that heal by 50% in four weeks were more likely to be healed in 12 weeks. And then, this one which was done kind of the earliest paper looking at the four-week interval. And this was the first consensus on the diabetic foot. I’ve mentioned that. That wounds that were unhealed after four weeks are cause for concern. So we look at advanced therapy in closing wounds. And I think it’s important to consider the wound closure reconstructive ladder. John Steinberg and Chris Attinger talked about this a lot. But this is closing a wound from something that’s very simple to the most complex. The simplest thing is secondary intention, basically letting a wound heal by itself. You debriding it, you providing a moist wound healing environment, taking the pressure off of it, and it will heal by itself. Then, you have a delayed and a primary closure. And this includes probably skin stretching devices. You have skin grafts, both split-thickness skin grafts and full-thickness skin grafts. There’s also flaps and those are both either random flaps or pedicled flaps. And then in the more complex case, free flaps. And then we have these tissues and matrices. A lot of them that there’s a lot of them out in the exhibit hall right now, but they all probably fit somewhere in between secondary intention and primary and delayed primary closure in their complexity and in the way that they work.
[15:00] A lot of these products, the ones with cells in them, they don’t actually even engraft into the wound. I know there’s some disagreement over that but these cells act like growth factor factories and give a lot of growth factors into the wound, but they don’t actually become a part of the patient. And you know that because they are still healing by secondary intention. They’re still healing from the margins in. They’re just doing it faster. And so you’re getting all of those growth factors that are being used like a growth factor pharmacy. So I don’t have time to go through all of the different products but what I did do is some that I’m very familiar with the evidence for and this is not all of them. So if your favorite products aren’t here, don’t get mad at me. Some that I’m familiar with the evidence for, we classified based on the class of their evidence. And some will say that it’s unfair to put Dermagraft and Apligraf in the PMA category higher that the RCT. And the reason is products that are amniotic products like EpiFix, they don’t actually have to go through a PMA, a DFA, they’re human products. If they’re minimally processed, there’s very little regulation at FDA because you don’t have to have every heart approved when you do a heart transplant. And so, this is the same idea with these human products. So they never will get to that level of evidence. They’ll never get to the PMA. They’re not required to go through it. But, the PMA does require these companies to do a lot more study, both safety and efficacy in order to show that that not only is this going to be safe for the patient but it’s also going to work. And so, I think the weight of evidence is higher behind Dermagraft and Apligraf for this. There are several products that have randomized controlled trials. These are two of them that you see there. And then there are some products that just have retrospective trials. So they had done a bunch of patients with one product and went back and looked at and see how they heal. There’s no comparative group so that makes it difficult to see if you’re having an effect through study format. And there’s some that really don’t have any evidence for diabetic foot ulcers. There is a diabetic foot ulcer trial underway with Integra but there isn’t any evidence for the use of it in diabetic feet. I’m going to show two cases of something that I think is really cool right now. And we’ve been doing a lot of these. And they’re available. This company is out here in the area too. So you can get some hands on with this. The device itself is called CelluTome and it’s made by KCI. But the technique is called epidermal grafting. So it’s not that CelluTome heals diabetic foot ulcers, it’s that you decided to do an epidermal graft and the epidermal graft would heal it. This is only a product to harvest something for you. No different than a dermatome if you’re using in the operating room and if made by Zimmer. You wouldn’t say, you know, Zimmer healed this diabetic foot ulcer. It’s the skin graft that healed the diabetic foot ulcer. So, this is a new tool that allows you to harvest an epidermal graft in the clinic without anesthesia and with no or minimal pain. So this looks like a cheese grater. You strap it on the patient’s leg and then there’s a head that goes over the top of it and that heats up and provides suction. And after about 40 minutes, you can see through this head, there’s a little window there and it’s actually not that difficult to see but you can see they’re micro-domes, little domes of blisters that are forming through that apparatus. And once they get to be that height then you’re done. So you stop the machine, you take off the head. And then you put a piece of Tegaderm on the domes and this will cut them. So, this blade comes out when you take the blue lever back and forth. And that cuts off the domes. And so now, what you have is the Tegaderm with a bunch of little dots of skin on them and just in rows. And you could take that and put it anywhere you want. And I don’t like to put occlusive dressings on diabetic foot ulcers. So, the next thing that we do is we usually make perfusions through it. And then we put a bolster dressing over it, usually with foam or something to, you know, so any drainage that comes out is absorbed into the foam. And so, since this is a human tissue from autologous, there’s no FDA clearance. You can put it anywhere you want and use it. They’re going through studies right now to study it on diabetic feet and to make sure that it works, but it’s very interesting. Then this is the donor site. And there’s no scarring. And like I said, there’s only been a couple of patients that felt some tugging. But in general, they don’t feel any pain. And you just put a Tegaderm over this, there’s no bleeding. And that’s always healed by the time they come back in a week. So here’s the ulcer that we used it on. This was an open TMA that had a split-thickness that partially healed and a part that’s under a lot of pressure failed.
[20:05] And so, we can either take the person back to the operating room and do another split-thickness and do some offloading. Or we can try this in the clinic with offloading and see how this works. And so here, the purple is Marathon. I use skin adhesive to kind of hold the edges down. And you can see the dots of skin here. All these little dots right there. And so you’re covering this part which is the ulcer, but you’re also getting overlapped and that doesn’t matter. And then, this is him, this is little dark but this is him after 5 weeks. It was completely healed but you have to do a really good job of offloading in these cases but it saved me from going back to the operating room again. There’s another quick case. This again was a split-thickness skin graft that had a partial take. And this area is well-vascularized, ready for some type of graft. You could use any type of graft here if you wanted. And so we have the Tegaderm on. You can see the shiny there. And then, what we did was we used a piece of foam like I said over the wound and I tried to bolster it down. So I’ll put Steri-Strips over the foam just to hold it in place and bolster it down. And this was after two weeks. And it was pretty much epithelialized here. There’s a little spot that was open over there. And then this is after six weeks completely healed. So, this is something we’re really excited about. I showed you two really good cases I’ve done 18 times and has worked about half of the time. And, you know, sometimes people say, well, that’s not a very good batting average. But, these are all really complex patients that that if I can do it and it works half of the time and save me from going to the operating room or save this person from going to the operating room, I think that’s a pretty good success. And we’re doing it sometimes and failed in cases where a split-thickness skin graft has failed. And this is one of my favorite quotes. And you may have heard me say this before, you heard me lecture, but it’s from Will Rogers, no relation to me. And he says, “Even if you’re on the right track, you’ll get run over if you just sit there.” And that’s really true in cases of the diabetic feet where you could be doing some of the right things but if you’re not moving fast enough down that track, you’re going to get run over by that infection that’s just around the corner and have to start all the way back at the beginning. So thank you very much.