Anthony Tickner, DPM reviews the current evidence based medicine on offloading devices. Dr Tickner presents why Total Contact Casting is the gold standard for off loading DFUs and gives compelling evidence that this is the treatment we should all be using.
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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Anthony Tickner, DPM
Saint Vincent Hospital/RestorixHealth Wound Care Center
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TAPE STARTS – [00:00]
Male Speaker: And now our next speaker is new to our podium Anthony Tickner is from Worcester, Massachusetts not Worcester but Worcester, Massachusetts Saint Vincent Hospital where he is a trained as a director of the program there and the Wound Care Director. He’s going to be talking about “The use of TCC and DAMA for the Rapid Closure of a DFU in an Obese Patient with Lymphedema.” DAMA I think that’s but Dam Amnion, is what the DAMA stands for? I didn’t know what DAMA was but and the TCC in integrating these components in getting patients to heal. So, let’s walk on Dr. Tickner to the podium.
Anthony Tickner: All right, okay. So, that is not a picture of our hospital, just in case you are wondering. Won’t that be great? You’d love to go to work every day? So, what we did is this is actually this case was born out of a Superbones West last year. And I was actually there not to speak but to go to a physician leadership conference for RestorixHealth, part of our Wound Care Center. And then the process we had this patient at that time and then, you know, as you’ll see through the slides, he’s a very large individual, very complex situation, you know, just a big, big BMI and everything else, all the comorbidities. So, I spoke to a few people at that meeting and I said, you know, he’s come to us from a different facility and he’s got this chronic right heel ulcer that won’t heal. You know, he’s going to lymphedema clinic, he’s going. He’s getting his compressive wraps. He’s got special shoes. We’re trying to offload him. What can we do? So, I thought to myself, well, let’s try to do a modified total contact cast where we’re not going to mess with his, you know, his girth or compromise the fluid or the edema but we’re not getting enough just by his traditional wraps. So, disclosure, invite a faculty of Superbones, no conflict of interests, like I said. This is actually a paper that we submitted to podiatry management as well. So, look for that in the November-December issue this year. I’d like to thank Dr. Frykberg, and Allan Sherman, and Michael Shore, and Darrell, and the whole team for inviting me. So, a quick overview diseases and the VIPs we’ll talk about, offloading guidelines and evidences review, effective offloading by design to help heal wounds and also the creative use of this total contact cast and that DAM amniotic tissue. It’s actually dehydrated amniotic membrane allografts to help heal a DFU in a lymphedema patient. Quick learning objectives, we want to amplify through EBM not EDM, we are in Vegas, and historical data that TCC is the gold standard for offloading DFUs, determine when adequate DFU management is being utilized and when it’s absent. We also want to quickly talk about different types of the offloading devices and created an awareness that difficult non-healing wounds and large patients can and should be treated non-conventionally. We know that the patients that come into our clinics and come into our offices aren’t being adequately offloaded at majority of the times. Just take their insoles out of their shoes and you can see, kind of, gives you a little, kind of gives you a little bit of, you know, a clues to what’s going on where they’re putting more, most of their pressure. This was covered a lot today and yesterday but it’s worth, you know, going through again. Diabetes in the United States, it’s on the rise; 8% of the US population continually on the rise, 26 million people. Of those people 40% to 60% of people with diabetes have neuropathy. The other half have PAD, some of them have everything, foot ulcers making up 6% of the DM population at 1.5 million people.
On to critical limb ischemia which we don’t want to get to 1.5 million people. Down to limb loss 80,000 people per year or 80,000 limbs per year. So, from a health care point of view, it’s expensive and Medicare and the different providers are already doing this now but it’s going to be even more profound in the future where it’s going to be put up or shut up or X amount of dollars to heal this patient and good luck. So, nearly 80,000 lower extremity amputations are performed in diabetics each year. The two-year costs involved with hospitalization, prosthetics, rehospitalization is almost $100,000. The projected lifetime healthcare cost to treat a patient that’s undergoing an amputation is over a $500,000. Five year mortality rate for these different types of things we see in our patients. Patient goes into their primary care doctor and says “I don’t feel good” next thing you know, there’s blood work, there’s labs, there’s all kinds of testing. Doctor comes back and says, “Mr. Jones, I’m sorry but, you know, you have a carcinoma or you have a cancer.” That patient is going to run. They’re not going to walk. They’re going to run to other appointments. Get in there. They’re going to be scared. Yeah, look at neuropathic ulcers, five year mortality rate is over 40% higher than prostate cancer, breast cancer and Hodgkin’s combined. Yet if you tell a patient, “Hey, you got a neuropathic ulcer,” are they going to run? No. So, there’s no sense of urgency . We talked to patients about diet, exercise, lowering your sugar, stop smoking, kind of like a three-ring circus of, you know, noncompliance. So, here’s a little picture here, exercise block, place the block on the floor, walk around it twice, sit down relax, you just walked around the block twice. Good diabetic foot ulcer management, well, it starts with a good history and physical. So, we need to get the information before we can figure out the plan. Through wound assessment and treating, we want to look at their blood supply; we want to look at if there’s an infection present; we want to look and see if they’ve been debrided or offloaded or if their wound is dry, if the wound is more than, you know, if it’s overly wet. Timely wound healing is less likely to occur if we don’t have a comprehensive plan including offloading. Consensus guidelines, this is a paper from JATMA 2014 and what it’s basically, the gist of it is the management of diabetic foot ulcers through optimal offloading and, you know, I don’t know how many people are aware of this but when you come to these conferences you’re really, really lucky because a lot of these papers that we reference that we talked about, you have a lot of these people that did this in the audience. So, two people that are here that I know of Dr. Frykberg, Dr. Lee Rogers. So, it’s a wealth of knowledge at your hands if you have any questions about anything and it’s really good to consult with people. Down below here, this is kind of the whole meat and potatoes of the paper. Total contact casting is the preferred method for offloading diabetic plantar foot ulcers as it has most consistently demonstrated the best healing outcomes and is a cost effective treatment. Let’s look at some different examples of offloading devices. We have removable devices, non-removable devices, and no evidence that supports some of the devices. Yet, we use them. We use them all the time as Dr. Brownlee just had his talk about hammertoes. After you do a hammertoes surgery, one of the first things you do is surgical shoe, post-op shoe. You may modify it and do a CAM walker or something else or knee roller or knee scooter but we use these all the time. So, examples of removable offloading devices, we have pneumatic aircast walkers, CAM walkers, DH walkers, half shoes, CROWs for Charcot and other. So, removable offloading devices with no evidence custom ankle orthotics, surgical post-op shoes, heel relief shoes.
Again, I’m not up here to be hypocritical, I use these as well but if you look at all the literature, all the data, it doesn’t, there’s nothing out there that says, you know, “there’s a study of 20,000 surgical shoes XY and Z.” Examples of non-removable offloading device system, well, this is where we get into our total contact cast, our plaster fiberglass traditional total contact cast and removable instant total contact cast which is a softer material. Sometimes patients like to bling out there cast. Is Eric Trikola [10:42] in the audience? No? He left. But I think this is one of his patients but I like the slide so much because patients don’t necessarily need to enjoy having a non-removable device on them but, you know, if they need to do what they need to do, good, they’re compliant. Lee Rogers was so gracious to let me cast him in a wheelchair but if anybody knows Lee, they know he’s not very compliant so I had to lay him down. But all kidding aside, there’s a picture of my son planking, so the gist of everything is you got to get people off their feet and total contact casting is going to help definitely offload them. So, some more removable devices and again this is from the consensus document, you can either go JATMA online or talk to the, you know, the folks of Derma Sciences who helped with this in the beginning. But if you need a copy of this, you know, it’s very interesting because it goes through, it does all the work for you Dr. Frykberg and its associates, they look at a bunch of data and basically the removable devices and you have evidence for that device, yes or no? And level evidence. So, you look at walker cast, you look at diabetic shoes, you look at surgical shoes, you look at, you know, the CROW walkers, fixed-ankle walker, there’s evidence to show that these devices work and there’s also a kind of a grading system that would tell you, “Okay, well, you know, there’s not a lot of stuff out there that says that these worker do work,” and then there are some devices that have a lot more evidence to show that they’re – to back them up. So let’s look at non-removable devices surgical techniques and this is interesting because you look at total contact casting, different types of contact casting, football dressing, soft contact casting, look at these surgical techniques with debridement, external fixator. Well, we know that debridement, there’s evidence to show that it’s going to help. But the level of evidence is very low because we don’t have tons and tons of data that shows us that this is the end-all be-all. So it’s not so much a negative thing to say moderate or very low. It’s more of a recommendation that we need more. Again, crutches, canes, walkers, rolling walkers, bed rest, we all use these, we all use these but there’s no data that says, you know, 20,000 people had a knee scooter and were compared to this group or that group. Offloading options by condition, you see here, we have different devices up on the top. We have total contact cast. We have some boots. We have removable devices, some types of surgical shoes, and some braces on the end. And then you have different wounds along the side here and then the blue dots are basically what they’re indicated for. So, with a total contact cast or with a boot, whether it’s removable, non-removable, a lot of them can be used for a lot of these different things. Study done by Dr. Caroline Fife out of Texas, she has a massive amount of data that she could access, so this is from the US Wound Registry and what it was was a compilation of data from over 11,000 patients with over 25,000 DFUs in total and you see the demographics there.
Some of mean age, and mails, and everything like that. Now, you look over here, what they were looking at is types of offloading devices so they looked at cast shoes, shoe modification, CROW walker, TCC and others. Of all that data that they collected, what they found was there’s not a lot of evidence, there’s not a lot of research that they could find showing fixed ankle CAM or some of these other devices were being used. So non-removable total contact casting or even instant total contact casting, more evidence, more reference pieces of data. TCC is something that’s very underutilized but there is a lot of data supporting it. It’s kind of that difficult interface to get your patients into the total contact cast because it is non-removable but it is on the flip side one of the most, you know, research aspects of offloading. So, TCC has a healing rate of about 90% within 5 to 8 weeks. Yet, we aren’t fully utilizing TCC. I mean, look at this poor guy. He could have used something to help offload him. There is a gap in practice. Again, this is data from the US Wound Registry where the eligible diabetic foot ulcers treated with TCC, and the eligible diabetic foot ulcers treated with non-TCC methods. So, you see the non-TCC methods is all purple, yet 3.7% of the time the eligible people that could be put into a total contact cast, they’re actually getting casted. So there’s a big discrepancy. Study done in 2001 by Dr. Armstrong and others basically showed that the percent of healed wounds was close to 89.5% compared to removable cast walker or half shoe in a time of 33.5 days compared to 50.4 days with a removable cast walker and compared to 61 days with a half shoe. His buddy, Dr. Lavery a few years later in 2014 did a similar study with just a little bit of variation, so here you see percentage of wounds healed is 88.9% with TCC, 50% with a healing sandal and then 40% with a shear-reducing boot. And you see here, 88.9% of people were healed in 5.4 weeks compared to the data from 2001, those numbers all look very, very close. So then we look at amputations and infections with people that are being total contact casted compared to people that aren’t being total contact casted. And you see that amputations and infections are nearly in half, so you look at the numbers, TCC is a lot lower, non-TCC a lot higher, TCC a lot lower for infections, a lot higher without. So we’ll look at a quick animation of mechanical perspective of normal ambulation, whether you’re diabetic, whether you’re neuropathic, whether you’re completely healthy, no medications, everybody is going to have the same types of forces when they ambulate. You’re going to have pressure forces coming from the ground, you also going to have shearing forces sliding back and forth. So, that’s normal. Now, what if we increase all that pressure in somebody that doesn’t have sensation? Well, they start to develop an ulcer, could be on the heal; could be on the forefoot, it’s almost like a domino effect sometimes. One pops up, another one pops up. So, we want to try to reduce these forces. The total contact cast is the optimal device for protecting neuropathical [indiscernible] [19:36] during ambulation, this device differs from a typical orthopedic cast, you’ll have people ask you, “Well, why can’t I just him on a CAM walker? Why can’t I put him in a different type of cast?” This was done in 1994 by Dr. Caputo. This was a paper from the New England Journal. So, okay that patient agrees…
…to be casted, why would we want to put them in a prone position? Well, there’s so much data on that as well. Placing the patient in the prone position, knee flexed, knee and ankle at 90. Posture calf muscle shifts approximately and you get that conical effect. Sometimes it’s more comfortable for them too to relax and not see everything that’s going on and you’re not going to strain yourself trying to lift their leg up and manipulate the plaster or the fiberglass. Prevents edema because you got gravity working with you and helps prevent high pressure areas of the cast. So, the two major, let’s look at the two effects at two levels, macro and micro. So, on a micro level – macro level excuse me, weight redistribution, we’re going to have pressure reduction, shear reduction. Let’s look at micro, angiogenesis, fibroblast migration, keratinocyte recruitment and you’re going to get a lot of that cell re-epithelialization. This was a study done by Dr. Alberto Piaggesi out of the University of Pisa in Italy. And very highly effective study but very simplistic as well, it’s a histological study which you, in a nutshell, you have two groups, you have one group that has total contact casting, you have another group that has the control group which is basically crutches and a surgical shoe. Now, if somebody is paying attention and they’re compliant and they’ve got a surgical shoe and crutches, you’d say, “Okay, well that’s pretty good.” What he found was that the deleterious features, hyperkeratosis around the wound, around the ulcer, fibrosis inflammation, cellular debris. And you look at these numbers, don’t worry too much about the plus or minus or the, any of that, but just look at the number itself, a lot higher in the control group that has crutches. A lot lower in the TCC group, look at the beneficial effects, granulating tissue, cutaneous annexes, capillaries, control group with the crutches and the surgical shoe. A lot lower the beneficial effects, a lot higher with TCC. So, we’re talking about offloading people and getting them into something that’s non-removable, locking their ankle at 90, reducing their stride length, protecting them in the process and trying to heal their wound. What’s going to be better than that? Well, if we can get some tissue or if we if we can get some advanced product on them as well, then we have, you know, a chance to speed things up. So, this is just the quick slide on the different types of things we use, whether it’s pig, cow, cadaveric, you know, a lot of things discussed today and throughout this conference. A lot of placenta, amniotic, you know, all kinds of good stuff. So, for this situation we’re going to talk about amniotic tissue, dehydrated amniotic membrane allograft. Then, you’ve heard this before so we won’t belabor the point too much but it’s been around for a long time, mostly in eye surgery and different types of surgeries and the past 20 years or so it’s been so highly regulated that we’ve only been able to use it a lot more readily. Amni on the biological properties non-immunogenic, anti-adhesive, anti-scarring, anti-inflammatory, anti-microbial. You hear a lot of very, very educated seasoned speakers talking about this like I stated before. And the reason it’s so effective is because we don’t want to put something on to somebody’s body that the body is going to reject, okay? So, that’s a major, major point. And especially you don’t want them rejecting something inside of a cast because then you take the cast off and it’s like hurricane TCC. So, the benefits of closing the wound faster, we’re going to lower the infection rates, prevent grade escalation and maximize patient and provider outcomes. So, let’s get to the case, I wish I had a case series but really when you look at this, I mean, if anybody else has any patients like this, maybe we can collaborate because this is 6’9, 500-pound, guy wearing a size 18 shoe.
BMI of 53.6, with a right-heel ulcer, 2.5 times 2.4 times 1.0. And he’s a giant, obviously, that’s not him, I got that off the internet but bilateral lymphedema, continually being treated at another facility, comes to CS for a second opinion. So, that’s the wound, we clean it up a little bit, we get a lot of the junk out of there. We used traditional TCC. We may not used these products directly but similar. And you can see on the side here, this is just an internet photo of a completed traditional TCC. Traditionally, you’d use a soft layer plaster, fiberglass, then you use a fiberglass splintage or something to bolster the area and make it a little bit more firm. And then you use more fiberglass and non-adherent outer layer. So, in his case, this is actually his leg and that’s the chair, I mean, you all know the hospital chairs and how big they are. He’s taken up the whole thing. His leg is huge. That’s the stool. His foot takes up the whole stool. I know Dr. Jensen down in the Florida and Dr. Jaakkola over in the Denver like to sometimes do multiple foot plates underneath. We were thinking about that but we decided to do one-foot plate, but overall he took about three kits of traditional plaster fiberglass and other materials. So, compressive Velcro-style wraps on a left side and like I said three traditional kits on the right. And again, you look at his leg and he’s over here he’s compressed. He’s got his big custom-made diabetic shoe on this side. He takes up the whole chair. Look closely right here, there’s a padding that goes down the patient’s leg if you’re not too familiar with total contact casting. There’s padding you want to put down the anterior aspect with the leg all the way down. We put two-layer side by side because his leg was just so huge. Extra padding, this is not something that typically you would do, all along here but we kind of modify, this is a nice spongy material that sticks on the other side and we just padded it all around the toes, all around the dorsum, and around the malleoli. The reason for that is because we had to figure out a way to try to compress this guy safely but also put them in a non-removable rigid device where he could heal his wound with the dehydrated amniotic membrane allograft on the wound as well. So, in five weeks after casting and using the DAMA, he’s getting small, he’s almost completely healed. It’s worth noting the kind of the protocol we did too. We casted this individual Monday and Thursday every week for nine weeks; the amniotic product was put on once every two weeks for a total of three pieces. So, week 1 through 6 he got amniotic membrane to the wound in addition to being casted twice each week. So at nine weeks, he’s completely healed and we joked, we had started laughing and we’re like “This is, Medicare is going to love this, you know, their 9-week rule with routine foot care.” So, kind of some of the highlights of what we were seeing. Initial leg circumference of his right side at the widest part of the calf was over 70 centimeters before treatment. Final right leg circumference at the widest part of the calf after was 54 centimeters. So we got a reduction of 23%. The wound reduced 60% in four weeks and was completely healed in 9 weeks and this was an individual that was – came to us and had a wound for over two years, and we don’t know what the hell to do with him. Initial weight was 500 pounds; final weight at the end 9 weeks was 450 pounds, so weight reduction of approximately 10%. Not only was it a success because we got this large individual healed with a very difficult wound, we thought outside the box, you know, if you don’t make mistake, you’re doing wound care. I’ve been burnt plenty of times but if you don’t think about things at different way or consult with all your colleagues and figure out what you can do and get some ideas of what can work and what cannot work, you know, you got to use your resources. So in conclusion, don’t be afraid to think outside the box, just be very careful.
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