Section: CME Category: Wound Care

The Use of Injectable Micronized Amnion Chorion Membrane in the Treatment of the Lower Extremity

Matthew Garoufalis, CWS, DPM

Matthew G Garoufalis, DPM, CWS discusses the many uses of dHACM (dehyDrated human amnion and chorion membrane). Dr Garoufalis discusses the future of wound care and the advantages of injecting this mixture directly into the wound and applying it in day-to-day wound care cases or in very difficult wound subjects. He also offers injectable dHACM as almost a panacea for future wound and joint care.

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Goals and Objectives
  1. List the advantages of using dHACM for injection
  2. Review clinical protocols for injection
  3. Describe the application and follow-up process
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  • CPME (Credits: 0.5)

    PRESENT e-Learning Systems is approved by the Council on Podiatric Medical Education as a provider of continuing education in podiatric medicine. PRESENT e-Learning Systems has approved this activity for a maximum of 0.5 continuing education contact hours

    Release Date: 03/16/2018 Expiration Date: 12/31/2020

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    Matthew Garoufalis has disclosed that he is a consultant, adviser and speaker for Ortho Dermatologic, MiMedx, Acelity.

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

    Male Speaker 1: We're going to welcome back to the stage Dr. Matt Garofalis. Matt -- All of you have had the opportunity to hear him speak, past president of the APMA, internationally recognized podiatric surgeon, very active in wound care, very active in clinical research. He is going to talk to us about injectable dHACM.

    Matt Garofalis: Good morning everybody. Thank you for being here this morning. Let me start off by thanking everybody that was able to attend our little VA meeting yesterday. We got a little high spirited at times there, but thank you for being there. I'm enjoying some of the great news about out our VA parity bill. I'm sure everybody has already sent off on the advocacy on their personal email already today. They are letters to their senators, right? I'm sure. If not, get going. And first day of December, so you know what that means. First meteorological day of winter. We're enjoying some great weather here in Phoenix, which is wonderful. I'm headed back to Chicago tonight, which is going to have a great weekend, 60 degrees on Sunday. On Wednesday, the high is going to be 10. Here we go. And also since I have the podium, let me remind everybody of the faculty development session. We'll be going on this afternoon at 2:30 and please feel free to attend if you're involved in teaching. Students and residents, I'm going to guarantee you, you will walk away with some interesting nuggets of information that you can use to improve your teaching techniques and will help you with your programming. That being said, since I always like to be on the cutting edge of things, I'm going to talk to you a little bit about using injectable micronized amniochorion membrane for the treatment of different things in lower extremity. As you listen to this presentation, understand that and you will hear me say this several times in the presentation, we're talking about something in the musculoskeletal world where we're not going to be using cortisone anymore. This is really going to be groundbreaking. We have a chance in podiatry and especially in the VA setting to be the groundbreakers for this kind of information and this kind of use of these products. So as you heard me speak previously, be creative, use your imagination, use science to push creativity and let's see where that goes. So let's get started. Of course, these are some of the learning objectives, protocols for injection therapy, some of the application that we're going to talk about and I'm just going to scratch the surface of those applications and of course the VA slide, these are my opinions and all that. And speaker disclosures and let’s get right into it. So, dehydrated human amniochorion membrane. It's been around for several years in a sheath form. This is what the sheath looks like. We understand the benefits of using an amniochorion membrane revolve around reduction in scar tissue formation, revolve around reduced inflammation, enhance soft tissue healing because it helps to build the collagen scaffold, growth factors, cytokines, promotes angiogenesis, inhibits MMPs. So it's everything that you want in a product you're going to apply to wound. And it's not going to be rejected, which is wonderful. So this is a slide that we looked at a couple of days ago and it has already been outdated. Because now instead of 226 proteins and growth factors, it's 528. So it provides a myriad of different growth factors, chemokines and cytokines to the area in which we're placing it. In chronic wound, as I stated a couple of days ago, we're actually transplanting this product, implanting it into an area where these types of proteins can no longer be produced by the patients themselves. So providing them a method of now using these transplanted proteins to close that chronic wound. So we actually reset that wound and jump start it and kick it into action when we apply this product. So because of our experience in using this product in wound care, somebody got the bright idea that what if we take this sheath and tear it up into a whole bunch of tiny little pieces and it's called micronized because they're very, very small. We got a blowup picture of what it would look like and put it into a vial so that it can be mixed with saline and then inject it.


    Initially, it was thought to be injected into the wound or then somebody got the idea of injecting it into a musculoskeletal area like a tendon or a joint. Well, let's look at that. Let's look at the product itself because we want to understand how the product works as I just mentioned some of the overriding issues that are important in this. We know about the growth factors and the chemokines and the cytokines. There are all sorts of collagen that are important, the whole myriad of collagens that we need to create a scaffold are there in this type of a product. We know that what we've seen in healing of wounds and soft tissue lesions that it works exceedingly well when the wound is prepared appropriately. We know that it involves human fibroblast. We know that it attracts mesenchymal stem cells to the area. The patient's own mesenchymal stem cells are attracted in a flurry and much more aggressively than they would be otherwise. So we know that it has some significant properties. We know that growth factors now play an important role in the wound healing cascade at every level of the wound healing cascade. This was unknown to us many years ago. Now we know that growth factors are important all along and if we can provide a product that has a multitude of these growth factors and signaling proteins, then we can help speed wound repair. Now, wound repair we think of in a chronic state, but how about wound repair in an acute state. So we will talk about that in a moment. This is a quote I would like to use from my good friend Gary Rothenberg about advanced modalities. The reason, one of the big reasons that we use these products is we treat the whole patient. We're not just treating the site of injury. We're treating the patient because we're trying to improve the quality of life, which is very important, which we're actually pretty good at when we use these types of products. So the first place that we use this is the injectable wound. This happens to be a neuropathic patient. He is not diabetic. He is neuropathic because of chemotherapy. He is a cancer patient, but probably one of the most stubborn patients that I have ever had to deal with in my life. He is one of the case studies I showed you a couple of days ago, but this is a patient who no matter what we applied to this wound, no matter what dressing we applied, no matter what product we applied, the dressing would pop off a couple of days later and no matter what offloading device we provided for him, he would be back in his tennis shoe. So we had him to leave the clinic in a beautiful dressed wound with a fancy product and an offloading mechanism. A week later, he would come back to the clinic with his own especially designed dressing, which is pretty minimal and a tennis shoe. So as you can imagine, that’s pretty frustrating. And of course in the VA system, you can't just kick him out of the clinic because they end up coming right back to you, of course. So we decided to, instead of placing a product on the wound, we're going to place the product in the wound. And we started doing injection therapy of micronized dHACM amniochorion membrane around this wound, around the wound edge because we want to stimulate the edge effect and then into and below the granulation bed. And at the time we did this, we would put a light dressing on and we just let him leave in his gym shoe because we're not going to swim upstream with this patient. He is going to throw away whatever offloading device we're going to use anyways and we're just going to go against the grain and do the injection and just let him go. So absolutely a little bit outside normal procedure here, but what we're able to do with this injection therapy and we discovered like, wow, there may be something to this. In 12 weeks, he was closed despite the fact that he wasn't offloaded, despite the fact he didn't have much of a dressing, there is something to this. So we started doing more of this. So now what we're doing many times is we're injecting amniochorion membrane into wounds into venous leg ulcers into diabetic foot ulcers as a way to stimulate the wound edge, stimulate the edge effect and stimulate the granulation bed because we can address those areas specifically by injection therapy. So then people got the bright idea, "well Gali if this works in wounds, where else can we use this type of a powder keg type of product to heal other sorts of injuries."


    And so plantar fasciitis study was completed and what they discovered in the plantar fasciitis study is that no matter what strength or amount of amniochorion membrane they injected into the plantar fascia, as long as they injected some, they saw significant healing effect in plantar fasciitis. So much so that it took one injection of this to take care of plantar fasciitis and the way it was done was through isolating the area of inflammation with an ultrasound looking at it and doing the injection right into the area of inflammation under ultrasound guidance. And they found that with one injection, they had a 90% success rate in healing plantar fasciitis, which is remarkable because we all know what a difficult time we have in treating plantar fasciitis and how many times we try all sorts of different modalities, surgical applications, things like that. And so what I decided to do, because I also have a private practice, is take this one step further. So in my private practice, I decided to try this out. How would this work in patients that have a choice that are covered with private insurance for their cortisone injection, but at the time I started this, we're not covered for the injection of the amniochorion membrane. So I put this little table together and discussed it with my patients and showed them the study that was done. And we know that cortisone injections were 50-70% of the time. We know there are some detriments to using cortisone especially consecutive cortisone injections. And I showed them there was a 90% success rate if we go this route. However, there was a cost to it, cost of about $300 that was out of pocket at the time. But I could bill for the other aspects of care such as the visit, the nerve block, ultrasound guidance and the cam boot. Subsequent to that and most of my patients decided they would go with the amniochorion membrane injection, so I had wonderful success with that. They were really excited because they would rather take one shot than the risk of having more than one shot. Since then, Blue Cross Blue Shield in several states has decided to cover these injections. So now it's a no-brainer. So what I have decided to do in my private practice and what we're beginning to do even in the VA is limit our use of cortisone. This is actually going to be the wave of the future where we're going to limit the use of cortisone because we know that cortisone is a Band-Aid. It's a short term Band-Aid. It's a hit or miss type of proposition. Yes, we're going to get relief, but for how long and how much. With this, we seem to get not only relief, but we get healing which is ultimately what -- that’s our job, that’s what we want to do. So interesting, so if we can do this with plantar fascia, where else could we use this type of material in the lower extremity. We know that it's already being used in knees, hips, shoulders, in the musculoskeletal community, but how about Achilles tendinopathies. Well, Achilles pain, we're surely not going to inject cortisone. We know that’s a no-no. We know we can't do that and we usually treat it with immobilization or some invasive techniques that are minimally invasive that may help it, but why don't we inject this and heal the area. Wouldn't that be something? So we know what the symptoms are of Achilles tendinopathy. We know what the typical treatments are, but now we can offer something a little different and these are some of the things that we can treat with injection therapy of dHACM, dehydrated human amniochorion membrane in order to facilitate healing. So think about the possibilities that we have here in using this type of product for these types of conditions, insertional tendinitis, retrocalcaneal bursitis where we can't use cortisone and these are difficult patients to treat. Immobilization is a treatment, but is that the best that we can do? If we can offer them something else, wouldn't that be wonderful? It would be really nice. So I put together kind of an application cascade here. So we usually block the area peripherally with a nerve block, select the appropriate amount of injectable that we're going to use and mix it with saline. I prefer to mix it with saline as opposed to local anesthetic because I believe that local anesthetic will break down some of the cells and you may not have it as an effective injection.


    So I do the nerve block first, mix it with saline, inject it and then because it's anesthetized, either 25-gauge or 22-gauge needle because they're not going to feel it, right?, it's already anesthetized. The larger the bore of the needle, the less cell degradation you get upon injection. Post-injection, limit activities, some ice, bracing, immobilization, usually in a cam boot or walking boot. And for pain control because this does create a certain amount of discomfort, usually Tylenol or Tylenol 3. We stay away from the NSAIDS because we have just injected one of the most powerful anti-inflammatories we can, so they are having a reaction to the increased fluid content in that tendon because it doesn't respond well to increased fluid content. So this is what we do. I actually got to practice this. The first time I gave an injection to Achilles tendon, I did it on my brother. I said you're going to be the guinea pig because he is just a stubborn, stubborn guy. He is a tennis player and he was upset that his daughters who were in high school and college were kicking his butt on the tennis court. Well, they should. You're not exactly getting younger and they're pretty young and physically fit. But he is suffering from Achilles tendinitis. And so he said, "you got to fix my Achilles tendon". "Oh sure, no problem, I can do that." He came in, we did an ultrasound scan. He had a 7-cm longitudinal tear in his Achilles tendon. It was about ready to blow up. And I told him that I said "you know what I think you're done playing tennis for a couple of months." He goes, "no I'm not. I'm not going to stop." "How about if we put in a boot. I mean we should take you to surgery and repair your Achilles tendon, but how about if we immobilize it." "No, I'm playing tennis tomorrow. What are you talking about?" Stubborn, right? Stubborn. So anyways, he says you have to fix it. Thanks for the challenge. I said you know there is something new out. This was several years ago. We're going to inject amnion membrane, placental membrane into your tendon. He thought I had really lost it then. He goes, "isn't that like when moms give birth, isn't that what you're talking about?" "Yes, that’s what I'm talking about." So after I calmed him down, this is exactly what we did. Under ultrasound guidance, we did three injections into Achilles tendon. I did put him in a cam boot, which he was unhappy about. This was on the Saturday. Called him on Tuesday. Doing great. "Yeah, hurt like hell on Sunday but doing great on Tuesday." "Still wearing the boot?" "Yeah, I'm still wearing the boot." Right, called him on Saturday, a week after the injection. Got my sister-in-law on the phone. Said, "boy, he feels great, what did you do. He is like a new person." I was suspicious with that comment. Let me talk to him. He is not here. Where is he? He is playing tennis. Oh God. Anyways, I got hold of him, of course yelled at him, which did no good, but I was able to get him back finally for another ultrasound four weeks after the initial injection. There was no sign of a 7-cm tear in the Achilles tendon, no sign. And I spent about 15 minutes using a whole bottle of gel looking at this Achilles tendon from every angle I could to finally understand that the Achilles tendon was healed and he was pain-free. So the application of this from an injection point of view, you can just imagine what we can do with this. We can do things with this that previously we would never have thought of injecting these types of areas, but because now we have this technology, we can do things that before we thought were impossible. They're not impossible anymore and with a little creativity, we can do away with the cortisone injections except for those people that absolutely needed covered by insurance. But introduce something that actually not only is a Band-Aid but can heal these areas once and for all. So we're beginning to see this. There is a lot of research on this right now in orthopedics and in podiatry. A lot of articles will be coming out in the next probably 6 to 18 months on this. So for those of us that have this technology available to use today, please start using it and get comfortable with it because you're going to see some amazing benefits from it. I was surprised with the benefits that I saw but when we understand the theory and understand the product that we're using and how it works, then we can understand why it is effective and there is one more data being produced to tell us just that. So with that, I'm all done. You won't see me up in the podium any more for this meeting which is you're probably really happy about, but don't forget the faculty development session this afternoon that will be fun. Thanks.


    TAPE ENDS - [20:32]