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Conferences Future of Regenerative Medicine 2017

Advances in Wound Care and Off Loading

Christopher Bromley, DPM

Christopher Bromley, DPM discusses risk factors for wound healing in the diabetic population. Dr Bromley outlines his recommendations for successful wound healing and the best methods for off-loading. He supports his discussion with case studies.

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Goals and Objectives
  1. Understand the current population risk factors for wounds
  2. Identify the role of Diabetes in Foot Wounds
  3. Differentiate the various risk factors from Arterial, Venous and Neuropathic perspectives
  4. Review Wound Care principles and current trends
  5. Review the role that the Total Contact Casting and other products can play in treatment
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  • CPME (Credits: 0.5)

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    Release Date: 03/16/2018 Expiration Date: 12/31/2018

  • Author
  • Christopher Bromley, DPM

    Chairman, Foot and Ankle Surgery
    Vassar Medical Center
    Poughkeepsie, NY

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  • It is the policy of PRESENT e-Learning Systems and it's accreditors to insure balance, independence, objectivity and scientific rigor in all its individually sponsored or jointly sponsored educational programs. All faculty participating in any PRESENT e-Learning Systems sponsored programs are expected to disclose to the program audience any real or apparent conflict(s) of interest that may have a direct bearing on the subject matter of the continuing education program. This pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are related to the subject matter of the presentation topic. The intent of this policy is not to prevent a speaker with a potential conflict of interest from making a presentation. It is merely intended that any potential conflict should be identified openly so that the listeners may form their own judgments about the presentation with the full disclosure of the facts.

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    Christopher Bromley has nothing to disclose.

  • Lecture Transcript
  • TAPE STARTS – [00:00]

    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, he’s 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, it’s a real pleasure to be back here in scenic Teaneck, New Jersey.

    As a disclosure, I’m not a scientist, I’m a foot and ankle surgeon. So we’re 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 don’t own any stock in any of the companies that are here today. If I did, I’d probably be somewhere warmer.

    Objectives today is just to understand where we’re at, as a population. How we – 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 I’ve 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 we’re going to talk about today is what some of those applications are, and what things are important to remember.

    I’ve 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.

    I’m 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 can’t forget, as amazing as these products are, is that we can’t 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 we’re not controlling out patients, if we’re not looking and talking about obesity, we’re going to have failure.

    As amazing as these products are, if we don’t look at, and understand what’s going on with our population, we’re 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. It’s probably going to be higher. We’re seeing increase incidence with child obesity. It’s 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. It’s really a whole body problem. It’s far beyond the podiatry perspective, it’s a cellular problem.

    We have arterial issues, we venous issues, we have neuropathy. My biggest focus on neuropathy was the centry, because that’s what I was told, but it’s really far beyond that, it involves the autonomic system, what’s going on with our patients nutritionally, what’s 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 it’s 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 don’t care if you use dehydrated cryolifelies, whatever you use, and it’s basically a signaling device.

    But if we’re 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 don’t look at all those other things, I’m 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. It’s 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. I’ve been in practice for almost 25 years, we – since – 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 we’re 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.

    [05:00]

    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 didn’t 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. It’s 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. That’s 6 million wounds, 3 million hospitalizations, 17 billion we spend. So there’s 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 won’t operate on any diabetic for elective surgery if their A1C is not down in the 7 to 8 range. We’ll continue to manage them until we can get them under control. Because it doesn’t matter how great a surgeon I am. If the patient’s blood sugar is not under control and their A1C is not where I need it to be, they’re going to fail.

    Regular visits, obviously, to podiatrist is really important. I think that one of the reasons we’ve seen decrease in diabetic foot ulcers and amputations is we’re 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 shouldn’t 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 I’m not going to treat you. If you’re not and you’re 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 it’s going to interfere with the patient’s 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 we’re 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, you’ve not removed all the bio burden, you’ve not made it bleed, you’ve just wasted that product. You can take a great placental allograft, $2,000 allograft, put it on wound, and if you didn’t debride it, if you didn’t make it bleed, it’s going to fail. Because it needs that fresh wound bed to communicate with the cells. You’ve got to be able to do that. If you haven’t done that, the product is going to fail.

    And then you’ve got to do great dressings, which we’ll 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 ‘90s and late ‘80s because it was very rigid and we had… more of the time we put contact casting on, we ended up with a problem. But the good news is there’s 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 ‘90s 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 we’re doing wound care or open surgical cases.

    So the regenerative things that we have available to us now, the gold standard really, don’t ever forget good surgical debridement, controlling the bioburden, really important in reference to what you’re 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 haven’t offloaded the patient, it’s going to fail.

    Advanced wound dressings are out there. You’ve got to control the moisture, either wound is dry or wet. One of the other… 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 didn’t 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 we’ll talk about is it’s very easy for me to keep the patient compliant. Because they’re in this TCC and they can’t do anything to it. They can’t take it off, they can’t walk on it, they can’t pick it, they can’t mess with it. It’s made my job very easier.

    What’s 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, it’s much easier for people to use a dehydrated product because the overall shelf life is easier, it’s easier to handle. And then over the last year or so, we’ve been using injectable amniotic fluid in our wounds.

    [10:00]

    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 I’ve been doing in the last year or so is actually injecting it underneath. So we’ll take the patient to the operating room, we’ll 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, you’re taking that cell signaling device, instead of hoping that it might be absorbed on the surface, you’re actually injecting it underneath. And you’ll 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 it’s the least effective because the patient can take it off. They can walk around barefoot. There’s no real way to offload a surgical shoe. It really hasn’t evolved those. And in fact, it’s 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, it’s really the gold standard for offloading a diabetic foot. And I admitted to you earlier when I was in the wound care center, I didn’t really love total contact casting because I was using a rigid fiber glass material. If I didn’t 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 didn’t really love it. But the materials have changed. The indication is obviously for non-infected ulcers, Charcot neuropathy, post–Charcot 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 that’s 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 sure… I had a… 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, I’m 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 the… this is from Diabetes Care 2005 showing you to offload. If you look at barefoot pressure versus in a TCC, that’s 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 it’s using a material that’s very, very flexible. So it’s 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 didn’t 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, it’s going to help exsanguinate the edema in the leg and then when you offload. So it increases your tissue profusion. So you’re using it as a pump, an arterial and venous pump because of the way the materials interact with the leg, and that’s been very, very effective.

    Basically, as I said, it’s supported by level 1 data, it’s very safe if you apply it correctly. You’re going to… if you look at the literature, they’re 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. I’ll 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 it’s a great offload, it really improves patient compliance, reduces sheer force, helps pump the leg and it’s 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 62–year–old obese diabetic with Charcot.

    [0:15:01]

    He’s had failed Charcot reconstruction, and he gets this chronic ulcer on the bottom of his left foot. This is as good as it’s ever looked, it’s 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 he’s been debrided, and he’s bleeding. And if you do these biologics, or you do TCC and you’re worried about bleeding, do good debridement put a compressor dressing on it, go see somebody else and come back when it’s got a chance to clot.

    So this is him, this is his TCC, it’s not one of the prettiest ones I’ve 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, he’s 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 don’t want to do that, because if you offload a wound, that’s 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 don’t do that. I’ll show you one of my slides where I did it, and you’ll see why it didn’t work.

    So this is week 1. So I apologize for the image, but if you look over here, that’s a week later. There is no biologics on it, that’s 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 it’s supposed to be applied.

    This is another diabetic, obviously he’s 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 that’s the first week back, actually, that’s 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, there’s 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 don’t want to do that, because the leg gets – 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, you’re really losing that pump. So I would recommend if you’re 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, you’re going to put something over the wound, based on how much drainage you have, and then you’re 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 it’s kind of a poly material. You want to make sure your foot is at 90 degrees. You’re 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 you’re going to hold the foot, not like this, but at 90 degrees, and you’re going to use a thin padded tape over the malleoli, over the anterior leg from the top of the foot up to the middle… almost the top of the tibia. And then you’re going to put a second layer of stocking and on.

    Now, I had experienced where I put this on in a different order, it didn’t work. So don’t do that. Follow the steps exactly the way I did. And then basically there’s no cast padding. All you’re doing is that two layer of stocking and that the second layer goes over those little stripes and then you’re going to start to wrap this flexible fiber glass from the front of the foot up to the top of the tibia. You’re holding the at 90, you’re contouring the foot. I have a little pillow that sits under the leg so I can do it on my own. And then you’re going to cut out. Once you get that on, you’re going to take the firmer piece that basically goes on the bottom of the foot like a big U. And you’re going to place that and it goes… there’s a flatfoot bed and then you’re going to put this U across. There’s a great YouTube video that I can show you from the booth.

    [0:20:01]

    And then essentially, you’re going to wrap the next layer from superior to inferior and just incorporate that all in there. Again, it’s a flexible material, it’s not hard. And hold the foot at 90, that’s really important. Make sure that you mould it in and you’re going to pull back that layer of cast padding and then you’re going to cut, make sure there’s 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 there’s enough room for the toes. And then, basically, you’re 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 don’t use a flat surgical shoe and I don’t use the cane walker. There are some great tools out there.

    When they come back, because it’s a flexible material, you don’t 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 doesn’t do it. I have a pair that sits on my desk with my name on it that no one else steals because they’re 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 wouldn’t reapply. And I think it’s really important to apply a fresh one. It takes about 5 minutes to do it. It’s 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 you’ve looked at their arterial and their venous issues.

    TCC has really… you know, has established itself as the gold center offloading the diabetic foot. I recommend doing it because you’ve got great compliance, great offloading. It’s far superior to what we used to have. It’s 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 that’s got everything laid out for me. It says TCC on it and there’s a little pillow that goes on the knee. I don’t know if you’re by yourself in your office or your clinic. I don’t need a lot of people to help me put it on. And it’s very inexpensive. It’s 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 you’re 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: That’s an excellent question. So most of the diabetic wounds that we have get stuck in the inflammatory phase, that’s why they don’t heal. So if a wound is stuck, these diabetic wounds, the reason they’re 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 we’re doing with regenerative medicine is we’re using… all the biologics are signaling devices, right? They’re not skin grafts. It’s a signaling device. So we’re using the biologic to signal the body to heal.

    So this is a great pair. They work synergistically together. I’ll debride, I’ll go ahead and apply the biologic and apply the TCC. Just like in a situation where I might be in the OR, I’ll do a great debridement, I might need a VAC. I’ll 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. I’ll try it next week. What about recurrence? After you have done the two or three application of the TCC.

    Dr. Brownley: Yeah. So that’s 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 don’t have time to give today, but it talks about we use the applications and how quickly they heal.

    [25:04]

    And not only do they get healed but they stay healed. What I see when I use TCC, with or without biologics, I’ve 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: I’ve got lots of Charcot cases I can show you. Again, if you get them healed, fully healed, they do well. Now, that’s no substitute for that Charcot to make sure they transition from a TCC to a torch or a crow. You have to make sure you’re not going to transition them into a new-bound sneaker. You’ve got to transition them into something else.

    But this tool is great. A lot of times I’ll send them to the orthotist, get the mold, get the foot… get that crow book or torch moving. And I’m using the TCC and I’ll transition them right into the brace or the boot

    TAPE ENDS - [25:57]