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Male Speaker: So Dr. Chris Brownley is going to speak to us on the role of wound care and offloading to regenerate the diabetic foot. Dr. Brownley is a very frequent lecturer for us in our meetings, heâs the chief of foot and ankle surgery at Vastro Medical Center and comes to us from Pokipsy, New York. Welcome Dr. Brownley.
Chris Brownley: Okay. Good afternoon, itâs a real pleasure to be back here in scenic Teaneck, New Jersey.
As a disclosure, Iâm not a scientist, Iâm a foot and ankle surgeon. So weâre going to talk a littlt bit about the regenerative medicine approach to the diabetic foot and the different things that we have to remember.
From a disclosure perspective, unfortunately I donât own any stock in any of the companies that are here today. If I did, Iâd probably be somewhere warmer.
Objectives today is just to understand where weâre at, as a population. How we â why is diabetes such an epidemic, why is the diabetic foot such a costly entity, differentiate the different factors that we have to deal with from an arterial venous and neuropathies perspective, and then look at the current trends that we have, and then what role we can coordinate our care and then looking at some of the total contact casting advances that are occurring now on wound care.
From a disclosure perspective, I have used all the amnion-chorion placental products for about 8 years, I have a lot of experience with dehydrated cryopreserved, and Iâve run a wound care center, and I still am involved in diabetic foot wounds on a daily basis.
All these products are great, and what weâre going to talk about today is what some of those applications are, and what things are important to remember.
Iâve had no trouble using dehydrated or cryopreserved. The dehydrated is easier, as far as a shelf-life, the response and the wound care healing that we have with these regenerative products is amazing.
Iâm talking about 2 or 3 applications healing times from 2 to 4 weeks versus when I used to run a wound care center with [indiscernible] [0:01:57] it would be months and months and months.
The things that we canât forget, as amazing as these products are, is that we canât forget to manage the patient. You know, the diabetes epidemic that we have in United States is huge. We have to remember to control the blood sugar in A1C if weâre not controlling out patients, if weâre not looking and talking about obesity, weâre going to have failure.
As amazing as these products are, if we donât look at, and understand whatâs going on with our population, weâre going to fail.
So we know that the overall numbers is huge, about 10% of our population is diabetic, and I think that number is from 2012. Itâs probably going to be higher. Weâre seeing increase incidence with child obesity. Itâs now the 7th leading cause of death in the United States which is huge.
What are the factors involved? You know, I remember being a young student when I first met Robert back in 1980s in Boston. And I remember thinking about diabetes as a foot problem. Itâs really a whole body problem. Itâs far beyond the podiatry perspective, itâs a cellular problem.
We have arterial issues, we venous issues, we have neuropathy. My biggest focus on neuropathy was the centry, because thatâs what I was told, but itâs really far beyond that, it involves the autonomic system, whatâs going on with our patients nutritionally, whatâs going on in the organ disease and why are they decreased.
We know, all of us in this room that one of the reason diabetic footstone heal is they get stuck in that inflammatory phase. And the reason the previous lecture was so great, is itâs talking about modulating all these biologic products that we have, are there to signal the cells to heal. Get them out of that inflammatory cell.
I donât care if you use dehydrated cryolifelies, whatever you use, and itâs basically a signaling device.
But if weâre going to use these products, we have to remember to treat the whole problem. We have to look at the patient. Did they have an autonomic neuropathy, what role is that playing on the cellular healing, do we have their vascular system looked at, their venous system, do they have an infection and then what are we doing for offload.
Because if I just put a biologic product on this ulcer and I donât look at all those other things, Iâm going to fail. Did I do good surgical debridement?
Annual cause for diabetic is in the billions, obviously you can see that diabetic foot-limb complications is greater than lung cancer, prostate and leukemia combined. Itâs a huge cause to our system and we have to be much more efficient at spending our dollars wisely and looking at the overall cause to the patient and the healthcare system if we fail.
CDC reports some good news. Iâve been in practice for almost 25 years, we â since â we look at the data from 2014 the CDC sees a dramatic decrease and amputations have decreased 65% over the last decade. I think that means weâre doing a better job as a team. We got podiatry primary care, vascular neurology endo, wound care centers have come full swing and then the overall awareness in education. So we as a team are doing a much better job than we did.
I remember being a young resident and being very excited when somebody would come in with amputated toe.
And a couple of months later, we get to do a transmit. And a couple of months after that we do a BK. It was a great surgical experience. We didnât do the patients any service but we did learn an awful lot. So obviously, foot and leg amputations are occurring four out of a thousand adults with diabetes in 2008. Itâs increased to 11 out of a thousand in 1996, and it continues to get better.
So overall, the wounds, there are about 30 million diabetics in the United States. 20% of those will get wounds. Thatâs 6 million wounds, 3 million hospitalizations, 17 billion we spend. So thereâs only 17,800 podiatrists in the country so we need as much help as we can get from our primary care and vascular colleagues.
Overall principles, very, very important to make sure that the patients are seeing their primary care on a regular basis, that their blood sugars are under control, their cholesterols as well. I wonât operate on any diabetic for elective surgery if their A1C is not down in the 7 to 8 range. Weâll continue to manage them until we can get them under control. Because it doesnât matter how great a surgeon I am. If the patientâs blood sugar is not under control and their A1C is not where I need it to be, theyâre going to fail.
Regular visits, obviously, to podiatrist is really important. I think that one of the reasons weâve seen decrease in diabetic foot ulcers and amputations is weâre doing a good job at doing diabetic foot offloading, diabetic shoe care regular visits. Important to evaluate patients and have them do their own self-evaluations.
Healthy diet is really important. I think one of the problems we have now is people are all supersizing everything they eat. No one takes the time to talk to diabetics about staying away from flour, sugar, all the things that they shouldnât eat. Obviously, avoiding smoking. I have a very strict non-smoking policy in my practice. If you smoke and you wanted me to fix you, you need to stop smoking or Iâm not going to treat you. If youâre not and youâre going to continue to kill yourself, why should I put myself out there? And also the importance of being active and exercise.
Overall, the key to blood sugar, obviously, is the blood sugar is out of control. We know that itâs going to interfere with the patientâs response from a vascular perspective, small vessel disease. The neuropathy is going to get worse. We need to look at how we are taking care of the wounds, making sure weâre doing good debridement.
These biologic products that we talked about in the last lecture are awesome. But if you put that biologic product on a wound that you have not surgically debrided properly, youâve not removed all the bio burden, youâve not made it bleed, youâve just wasted that product. You can take a great placental allograft, $2,000 allograft, put it on wound, and if you didnât debride it, if you didnât make it bleed, itâs going to fail. Because it needs that fresh wound bed to communicate with the cells. Youâve got to be able to do that. If you havenât done that, the product is going to fail.
And then youâve got to do great dressings, which weâll talk about. Offloading is huge. I spent many years in a wound care center. I was not a huge fan of total contact cast back in the early â90s and late â80s because it was very rigid and we hadâ¦ more of the time we put contact casting on, we ended up with a problem. But the good news is thereâs better offloading now and the total contact cast technology has advanced significantly.
The growth factor is obviously, as Robert said, we started back in the â90s with Regranex and also Apligraf and Dermograft. Those were all great products. I think those have been sort of eclipsed as has PRP with the biologics, using amnion/chorion and umbilical grafts have been very, very helpful for us, and whether weâre doing wound care or open surgical cases.
So the regenerative things that we have available to us now, the gold standard really, donât ever forget good surgical debridement, controlling the bioburden, really important in reference to what youâre doing to the wound to cleanse it, making sure that any underlying infection has been treated. Proper offloading is key. If you put a great product on and you havenât offloaded the patient, itâs going to fail.
Advanced wound dressings are out there. Youâve got to control the moisture, either wound is dry or wet. One of the otherâ¦ and pick the dressing that you feel comfortable with. HPO is still very effective. I always thought that HPO was a wonderful way to offload the patient five days a week for two hours. I also think we got to change their bandage five days a week. I think that was one of the reasons why it worked. I think the oxygen didnât hurt, but I think it was the daily wound care and offloading.
Avascular reconstruction, very important in patient compliance. One of the things I love about the total contact casting weâll talk about is itâs very easy for me to keep the patient compliant. Because theyâre in this TCC and they canât do anything to it. They canât take it off, they canât walk on it, they canât pick it, they canât mess with it. Itâs made my job very easier.
Whatâs new in 2017, over the last probably 7 to 8 years, is all of us are now exposed to the biologics, the allografts, the amnion/chorion and umbilical. In our practice, we use cryopreserved and dehydrated products. We have a freezer in our office. More often than not, itâs much easier for people to use a dehydrated product because the overall shelf life is easier, itâs easier to handle. And then over the last year or so, weâve been using injectable amniotic fluid in our wounds.
One of the things you can do is you have a wound like you see in the picture, you can apply a biologic to the wound. One of the things that Iâve been doing in the last year or so is actually injecting it underneath. So weâll take the patient to the operating room, weâll do a nice debridement, and instead of laying the product on top of the wound, we actually inject it on a 45 degree underneath. So basically, youâre taking that cell signaling device, instead of hoping that it might be absorbed on the surface, youâre actually injecting it underneath. And youâll see a dramatic change in how those wounds look within about a week. And they typically close within about two weeks or so.
So offloading solution, obviously, for a lot of us, you know, the most common off loading device for the diabetic foot is the surgical shoe. It is the most common but itâs the least effective because the patient can take it off. They can walk around barefoot. Thereâs no real way to offload a surgical shoe. It really hasnât evolved those. And in fact, itâs not wood anymore. Diabetic shoe with offloading or insert is not bad, but again, it still allows the patient to take it off. They are able to walk around on it. Ankle-foot orthosis, obviously a little bit more successful but a little bit more costly and it takes time to get the device towards walker and CROW boot. I like to use for long-term management of those diabetics with severe neuropathy and obviously a bone deformity.
So where does total contact casting fit in? Total contact casting, when you look at the literature, itâs really the gold standard for offloading a diabetic foot. And I admitted to you earlier when I was in the wound care center, I didnât really love total contact casting because I was using a rigid fiber glass material. If I didnât put it on right, it was a pain to put on. And a lot of times I would use it, I ended up with a new wound on maybe the back of the heel or the outside of the ankle where I was trying to heal a plantar wound, now, I have two or three more problems. So I didnât really love it. But the materials have changed. The indication is obviously for non-infected ulcers, Charcot neuropathy, postâCharcot reconstruction, delayed primary closure. Contraindications obviously, anytime you have an infection. The last thing you want to do is put it in an infected wound in a TCC and then end up with a bigger problem.
If the patient has significant arterial involvement, you have to be very careful with the TCC because they could end up with almost a compartment syndrome, you could end up with a problem. And those non-compliant patients, we all have them, you have to make sure that this is not someone thatâs going to try to cut it off themselves or do something to hurt themselves.
Other contraindications, allergy to cast material, which is pretty rare. If the patient has an underlying DVT or compartment syndrome, make sureâ¦ I had aâ¦ one of my post-op patients happens to be a physician. You know, doctors make the worst patients. He come in yesterday complaining about her leg pain and how my cast boot interfere with her leg and now she has tendinitis. And I thought, you know, Iâm just going to get an ultrasound. Sure enough, she had a significant DVT. So whenever you think you might have a problem in the calf, always get an ultrasound to make sure.
These are some of theâ¦ this is from Diabetes Care 2005 showing you to offload. If you look at barefoot pressure versus in a TCC, thatâs significant. And you can see down here, barefoot versus a conventional TCC and then some of the newer materials.
The big change in TCC now is that itâs using a material thatâs very, very flexible. So itâs a lot easier to work with. This is a typical rigid fiber glass or plaster cast, not that friendly to the leg. The newer TCC uses a flexible, soft casting material. It is much easier to work with, it contours to the foot and leg. And what happens is, and I didnât appreciate this when it first came out, when you weight bear in a flexible TCC, it actually pumps the leg. So on weight bearing on a TCC, itâs going to help exsanguinate the edema in the leg and then when you offload. So it increases your tissue profusion. So youâre using it as a pump, an arterial and venous pump because of the way the materials interact with the leg, and thatâs been very, very effective.
Basically, as I said, itâs supported by level 1 data, itâs very safe if you apply it correctly. Youâre going toâ¦ if you look at the literature, theyâre 90% heal rates in diabetics, typically at 5 to 8 weeks. My studies have shown a little bit less than that in a four-week range. It is a very, very effective. It has cut amputation rates significantly and there are only 4% of the patients who are really eligible are actually using this. And I think the reason the 4% is there is because a lot of us had trouble with TCC back when we first started doing it. So now with the new materials, I ask you to take a look at it and try some of the newer materials. I think it only takes a few minutes. Iâll show you a typical application.
This is just showing you diabetes care found to be safe and effective. The reason it does work as I said is itâs a great offload, it really improves patient compliance, reduces sheer force, helps pump the leg and itâs been significantly better at offloading. For instance, first metatarsal is 70% offloaded and 45 for the heel.
So this is one of my cases. This is a 62âyearâold obese diabetic with Charcot.
Heâs had failed Charcot reconstruction, and he gets this chronic ulcer on the bottom of his left foot. This is as good as itâs ever looked, itâs typically about 2 centimeters by a sonometer, and a good sonometer deep.
And no matter what I put on it, all the biologics I tried, it really never really responds. So this is what he looks like after heâs been debrided, and heâs bleeding. And if you do these biologics, or you do TCC and youâre worried about bleeding, do good debridement put a compressor dressing on it, go see somebody else and come back when itâs got a chance to clot.
So this is him, this is his TCC, itâs not one of the prettiest ones Iâve ever applied, but does seem to work pretty well. I gave a little bit of K-tape up here, and this is him ambulating in the TCC with a little rocker bottom boot. And he works actively, heâs an accountant.
This is his leg, the basically, the first we got. Now, what I did was, I put a little sober dressing on that wound, and then put the TCC around it. Really important when you do TCC, not to offload. Our instinct is, when doing wound care, is to put a dressing around it, to offload it. You donât want to do that, because if you offload a wound, thatâs going to be immobilizing the TCC, the offloading will actually interfere with that tissue pump perfusion to the wound edge that we talked about. So donât do that. Iâll show you one of my slides where I did it, and youâll see why it didnât work.
So this is week 1. So I apologize for the image, but if you look over here, thatâs a week later. There is no biologics on it, thatâs just a week of TCC. This is him at week 2, this is showing you the offload, and I did this, because I put this casing, because I want you to not make the mistake I did.
You see this impression? So this pad that I put on there, obviously, is going to interfere with the tissue perfusion. He did well, he went on to heal, but what we want to do is just use a nice thin dressing, and use the TCC the way itâs supposed to be applied.
This is another diabetic, obviously heâs had some toes removed, very non-compliant, really kind of a pain in the butt, get all these debrided off, get down to a nice beefy granular wound, and then go ahead, and apply. So this is the first day TCC measuring it, showing it back. I think thatâs the first week back, actually, thatâs week number 1 after the first cast. So significantly better. It goes on, I use a little bit of a silver dressing, and a little bit of Promogran with the AG in there, and then this dressing to absorb drainage. And he went on to do very, very well.
This is showing you, thereâs some studies in Europe where they redo the TCC, you can reuse the TCC week after week. And what I found when I was doing my work is that you really donât want to do that, because the leg gets â and particularly in diabetic with edema, the leg gets significantly smaller week to week, so if you take this TCC off, and you try to reapply it and secure it with more fiber glass, youâre really losing that pump. So I would recommend if youâre doing TCC, put a fresh one on each week.
This is an example of one of our ankle patients who walked all over a regular fiber glass cast, and you know as well as I do what happens when patients walk all over regular fiber glass. And this one is as I said, a week old, this one is a week old.
So TCC application is relatively easy, you do your good surgical debridement, as we talked about, easier, youâre going to put something over the wound, based on how much drainage you have, and then youâre going to apply basically a sleeve. The key is not to use the stock in that that they recommend, which is a non-cotton stocking and itâs kind of a poly material. You want to make sure your foot is at 90 degrees. Youâre going to put a little bit of synthetic, not cotton, synthetic cast padding around the toes. You kind of winded it around the toes and get a nice padding around the toes. And then youâre going to hold the foot, not like this, but at 90 degrees, and youâre going to use a thin padded tape over the malleoli, over the anterior leg from the top of the foot up to the middleâ¦ almost the top of the tibia. And then youâre going to put a second layer of stocking and on.
Now, I had experienced where I put this on in a different order, it didnât work. So donât do that. Follow the steps exactly the way I did. And then basically thereâs no cast padding. All youâre doing is that two layer of stocking and that the second layer goes over those little stripes and then youâre going to start to wrap this flexible fiber glass from the front of the foot up to the top of the tibia. Youâre holding the at 90, youâre contouring the foot. I have a little pillow that sits under the leg so I can do it on my own. And then youâre going to cut out. Once you get that on, youâre going to take the firmer piece that basically goes on the bottom of the foot like a big U. And youâre going to place that and it goesâ¦ thereâs a flatfoot bed and then youâre going to put this U across. Thereâs a great YouTube video that I can show you from the booth.
And then essentially, youâre going to wrap the next layer from superior to inferior and just incorporate that all in there. Again, itâs a flexible material, itâs not hard. And hold the foot at 90, thatâs really important. Make sure that you mould it in and youâre going to pull back that layer of cast padding and then youâre going to cut, make sure thereâs plenty of room for the toes. I pull that synthetic wrap that I put around the toes out. I just do -- I do that in the beginning to make sure thereâs enough room for the toes. And then, basically, youâre going to mobilize the patient in whatever shoe of your choice.
I think rocker bottom is better. There are some cheap alternatives out there, $10 or $12. I donât use a flat surgical shoe and I donât use the cane walker. There are some great tools out there.
When they come back, because itâs a flexible material, you donât need to use a cast cutter. Basically, if you get a nice pair of short bandage scissors, I prefer something from Germany. The Pakistani stuff doesnât do it. I have a pair that sits on my desk with my name on it that no one else steals because theyâre sharp. And I basically just cut up right up the center of the tibia with the scissors. And once you get through the first layer, then you go ahead and cut through the stocking and basically just pry it open and this will come off.
This is a slide showing you that you can reapply it. But I will tell you that I disagree with the vendor in a sense that I wouldnât reapply. And I think itâs really important to apply a fresh one. It takes about 5 minutes to do it. Itâs not difficult. I do it by myself.
Overall, the most important thing about the wound care regenerative space right is that, as amazing as all the products are, there is no substitute to doing great surgical debridement, managing the [indecipherable] [21:55] and managing the patient systemically, making sure that youâve looked at their arterial and their venous issues.
TCC has reallyâ¦ you know, has established itself as the gold center offloading the diabetic foot. I recommend doing it because youâve got great compliance, great offloading. Itâs far superior to what we used to have. Itâs very safe with minimal risks. It has increased patient compliance.
I typically have about 10 minutes to apply. Basically my staff brings in a bucket thatâs got everything laid out for me. It says TCC on it and thereâs a little pillow that goes on the knee. I donât know if youâre by yourself in your office or your clinic. I donât need a lot of people to help me put it on. And itâs very inexpensive. Itâs not like some of the other things that we have example.
And it typically takes me about two, maybe three applications to get most of the wounds healed. And that is not my experience in all the years I spent in wound care environment.
So we have a few minutes for anybody who have questions about offloading or some of the advances we are talking about.
I see that I either did a really good job or youâre still sleepy. Thank you.
Male Speaker: Just remember, all the fancy implants that we have do no good whatsoever unless you do proper offloading.
Yes, we have a question.
Female Speaker: So somebody has to ask. So if TCC is the greatest thing since live spread, what is the role of biologics?
Dr. Brownley: Thatâs an excellent question. So most of the diabetic wounds that we have get stuck in the inflammatory phase, thatâs why they donât heal. So if a wound is stuck, these diabetic wounds, the reason theyâre stuck in the inflammatory phase is because of the autonomic neuropathy and because of the comorbid conditions the patient has with their blood sugar. So what weâre doing with regenerative medicine is weâre usingâ¦ all the biologics are signaling devices, right? Theyâre not skin grafts. Itâs a signaling device. So weâre using the biologic to signal the body to heal.
So this is a great pair. They work synergistically together. Iâll debride, Iâll go ahead and apply the biologic and apply the TCC. Just like in a situation where I might be in the OR, Iâll do a great debridement, I might need a VAC. Iâll use a biologic under my VAC if I need the help because I can change that patient and get him out of the inflammatory phase and get him moving forward.
Male Speaker: I like that about putting the biologics with the TCC. Iâll try it next week. What about recurrence? After you have done the two or three application of the TCC.
Dr. Brownley: Yeah. So thatâs a great question. One of the things that we see, and you look in the data on the biologics, is that if you look at some of the papers that have been published, is when you use a biologic in a wound, in a diabetic wound, typically what you see is that not only did they heal faster but they stay healed.
I give another lecture that we donât have time to give today, but it talks about we use the applications and how quickly they heal.
And not only do they get healed but they stay healed. What I see when I use TCC, with or without biologics, Iâve got a much better healing and the patients, from a compliance perspective, they stay healed. They do well.
Male Speaker: Even the Charcot case?
Dr. Brownley: Iâve got lots of Charcot cases I can show you. Again, if you get them healed, fully healed, they do well. Now, thatâs no substitute for that Charcot to make sure they transition from a TCC to a torch or a crow. You have to make sure youâre not going to transition them into a new-bound sneaker. Youâve got to transition them into something else.
But this tool is great. A lot of times Iâll send them to the orthotist, get the mold, get the footâ¦ get that crow book or torch moving. And Iâm using the TCC and Iâll transition them right into the brace or the boot
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