Matthew G Garoufalis, DPM, CWS discusses the role of oxygen within the chronic wound and its influence on the wound healing processes. Dr Garoufalis outlines the reasons Cyclical Pressurized Oxygen Therapy works so well in healing, the types of oxygen therapies available, and their advantages and disadvantages. He documents his discussion with examples from his cases.
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TAPE STARTS – [00:00]
Male Speaker 1: Dr. Matt Garofalis [phonetic], well known to us all. He is from the Chicago area. He is going to be speaking on specific type of cyclical pressurized oxygen therapy, which is currently undergoing national and international clinical trials right now. So, let’s welcome Dr. Matt Garofalis from Chicago.
Matt Garofalis: Good morning everyone. Thank you for showing up early this morning. We're going to talk about this other oxygen therapy. We're all familiar with hyperbaric oxygen and we may or may not have the availability to use it and we may or may not have the availability to use this right now, but as we go along, I just want you to understand about this and about its upcoming availability and just want to make aware of it. So let’s get right to it. Some of the learning objectives that we're going to follow through here today, nothing outrageous, just want to learn a little bit more about this other therapy and of course the disclosure statement about the VA. I'll put that in there and it makes the VA people very happy. Speaker disclosures and let’s get to the brunt of the other presentation. We know about standard wound care. We know about all the steps that we have to take in treating the wound and in what orderly progression we follow, but one thing that we seem to miss sometimes or there isn't readily available to us is oxygen balance. It's something that plays an increasingly larger role in the treatment of wounds and if we're aware of this and can apply this technology, we often see that these wounds heal a bit faster. We know that there is a lot of bio-burden in the wounds and this is just a little graft showing the different types of wounds and displaying the different types of bio-burdens in each of these different wounds. And we also know that when oxygen is applied, the bio-burden level decreases. We have an opportunity to apply oxygen to wound in any of its various formats, we can aid that wound by decreasing the bio-burden. Now, there are different oxygen levels at different places in the wound and something that we're not always aware of, but if you look at this graphic, we can see that at different areas within that healing wound, we have different amounts of oxygen and this can dictate the performance of that ulcer in terms of rate of healing. And we can't always get these measurements locally either in our clinic or on rounds. We don't have the availability or instrumentation to have these precise measurements available to us, but this slide is to make you aware that there are differences in oxygen penetrations. So there are some facts concerning oxygen in tissues. We do know that healing improves whenever we increase the local concentration of oxygen. I think there have been enough studies with hyperbaric oxygen that demonstrate its effectiveness. Even though it may have been misused often times, we do know that it is effective in healing the wounds that we treat. So we do know that under certain conditions, supplementation of oxygen is exactly what we need to do to get to the next level in wound healing. We know that hypoxia and tissue death is very much a problem that we deal with when dealing with diabetic foot ulcers and other wounds. So if we can change the oxygen concentration, we can actually change what's happening at a cellular level and if you look at the bottom bullet down to mitochondria which I know that brings back some nightmares. We're going to talk about mitochondria little bit here for a few slides. Sorry about that. But it changes the function of what the mitochondria does in terms of producing the ATP that can energize wound healing. So we know that if we don't have the right oxygen concentrations, we end up getting conditions like these that can complicate wound healing or forestall wound healing and so oxygen plays a very important role in everything that we do. We know that chronic wounds lack adequate oxygen. We know that we need higher levels of oxygen in order to synthetize the appropriate amount of collagen in the appropriate structure to close the wound. We need oxygen to increase cellular matrix and we need oxygen for new blood vessel supply as well as to fight off infection. So as I said earlier, many of us can be or are familiar with whole body HBO, but then again there are some limitations for full body HBO.
We will go over those shortly, but it may not be available to everybody. So this pressurized oxygen system is becoming more available. Right now, it's readily available in the VA system and that’s where the majority of the studies are being done in this country. In Europe, it's readily available and the other arm of the study that I'll talk about in a moment is being finished in Europe. So we know that for instance in our hospital we use this and it's very easy for the patient to use. Oxygen is delivered in a humidified format. Patient uses this at home for about 90 minutes a day. It's very easy to apply and there are very few if any contraindications. So they are getting the benefit of oxygenation in their wound at home on a daily basis. So this is a busy slide, but it talks about the comparisons between hyperbaric oxygen and this topical or cyclical pressurized oxygen. We know that topical oxygen itself at term topical oxygen kind of doesn't have the best. The first time you hear about it, you'll go, "oh topical oxygen, I know about that. That’s a bunch of garbage." Well, that’s what I first said when I heard about this therapy too, but I wanted to tell you that this is a bit different. So I will go down some slides and tell you why this is different than the topical oxygen that you may heard about earlier. So let’s go right to some of the differences here and these are the contraindications. There is only one contraindication for the use of this modality compared to systemically produced HBO oxygen. So that includes a lot of patients. We know that atmospheric oxygen is important and there is a difference between non-permeable and permeable oxygen healing in wounds. So it does make a difference in wound healing. We know that in models, we can demonstrate that pressurized oxygen sinks to a level of about 4 mm into the granulation bed under cyclical pressurized terms, so this helps us to re-oxygenate the granular bed and defeat the bio-burden though we have many models that tell us this. This is a bit of a complex slide and we do go back again to our mitochondria and ATP. I know that’s bad nightmares for many of us from bio-chem and things like that. But what this slide demonstrates if you look at the blue bars that go up and down in three sections across that graft. The further to the right that we go by increasing oxygen, the more we increase collagen production and the more we increase ATP production and this is exactly what we do when we apply either HBO or cyclical pressurized oxygen. We go from wound at room oxygen levels that all of a sudden gets an increase in oxygenation, so you get better collagen production and better ATP production. So this wound then begins to heal much more quickly. So just by applying this type of pressurized oxygen, driving oxygen into the wound bed, we all of a sudden increase the metabolism that’s going on in that wound bed, which is a good thing. That’s exactly what we want to accomplish. We also see that in an oxygen-treated wound bed, we get neovascularization at a much faster rate because of the oxygen penetration, which is stimulating this ATP through the mitochondria. So we have studies that show this also. In human use, we see that there is a significant increase in oxygen levels at the base of the wound at the granular bed with the increase of pressurized oxygen almost immediately. So that allows for again better granulation tissue and better wound healing to occur very quickly. This slide demonstrates what happens to a wound with just 60 minutes of cyclical pressurized oxygen applied to this wound bed. We get a beefed up granular bed and increased vascularization almost immediately. You also at a cellular level, begin to get cellular changes in the tissue quality because of the hyperoxygenation -- easy for me to say -- that occurs at the wound bed. So even looking at the histology slides, we can see that there is almost an immediate change and difference in the tissue quality.
So that’s one thing that we want to do. We want to improve tissue quality, so it limits the possibility of further breakdown once this ulcer is healed. So we raise the pressure inside this boot between 10 and 50 millibars, almost up to half an atmospheric pressure and it's cyclical over this 90-minute period. And so you get an increase of pressure five times what it is at room pressure, half an atmosphere of increase. And at the same time, because of the cyclical pressurization of the boot, you are also decreasing edema and swelling. So you are increasing a pumping action to that lower extremity and that also increases circulation, decreases edema, takes care of the venous pump for you. So you're getting neovascularization not only by oxygenation but by physical pump activity. And it's humidified which allows for better penetration. So this is an effectiveness graph looking at this compared to other modalities and we compared it to negative pressure, we compared it to other forms of oxygenation and we discovered that we're right in the ballpark here with healing wounds with cyclical pressurized oxygen. We had very good results with this. This is just a very busy graph talking about the study that’s going on and some of the locations as to where it's happening, but it's a 220-patient study. What's interesting about this study is that even though it isn't complete yet, already been presented to CMS. CMS took a look at this study and they looked at some other studies done with other topical oxygen modalities. The other studies they looked at that had been done by other topical oxygen modalities, they threw them away. They said they were not appropriate studies in terms of CMS. They looked at this study and said, "well as soon as you complete the study, we would like to see the results because if you get the results from this study that you are anticipating, we're going to endorse this study and put together a coding package for this modality." This was last year. So we have some good things on the horizon, which is why we want to make a presentation to you about this modality because for some of you not in VA system you don't have it available. But shortly once the study is completed, it's going to be presented back to CMS and it will become available to you. These are some of the examples of the other oxygen modalities that are out there that CMS is not interested in because they do not find them effective, but they've been around for a long time and these are some of the modalities that have given topical oxygen a bad name. The boot, the bag that you put over the foot and you pump air in or the little modality that just streams air across the wound and that’s topical oxygen. They are pretty ineffective, but there are all these different modalities out there that have done some studies, but they are not appropriate studies. They are not validated studies. So one thing that works really well when we use this cyclical pressurized oxygen modality is we can use it with some of the other modalities that we have in the room next door to us. They work hand in hand extremely well. So you potentiate the effectiveness of these products when you add oxygen to the wound, which these work even better, the oxygen works even better. So there is also a cost factor involved. If we look at hyperbaric oxygen and a cost relative to the cost involved with this type of cyclical pressurized oxygen, we're saving money, which is one reason why CMS is so very much interested in this. They are trying to contain the cost of HBO and they are looking for another option to make available to the public. When they do that, this is that option that they want to make available to the public. So as soon as that study is done, we're going to be in great shape. So there is a workshop later this morning that we hope all of you can attend to get a hands-on view of how this works, but this is where the strongest technology is and the greatest interest is on this type of oxygenation of the tissues. There are all sorts of applications as you can tell by the slide that this can be used on. It's being used on sacral wounds, not just on lower extremity wounds, but as you take a look at this, think of some of the applications that you may find valuable when you use this on your patients. This is the study that Dr. Friedberg mentioned that was done last spring in Europe. So they are already looking at this in a very favorable light in Europe and this was at the UMA [phonetics] Conference just last May and they are going to be talking about it again at the meeting in Krakow next May.
It is even already on the agenda for speaking opportunities and go over this consensus document. So it's already making great headway there. So in summary it allows you -- this is what the boot looks like. It also comes with a chamber. So the little humidification port is down there and during the workshop, you'll be able to actually get hands-on with this and take a good look at it. So we think we have something promising here to offer our patients. Something that’s very easy to use at home and something that will make a big difference in the way that wounds are healed. Just a few quick cases. This shows you the difference in wound healing in just one week in this particular patient with a plantar ulcer. We have other patients. This is the difference in three weeks using pressurized oxygen in a patient that has a necrotic Achilles tendon that all of a sudden manages to get granulation tissue over the top of it. We actually saved this and didn't have to do a major debridement on it. This is that patient further down the road on his other side with granulation buds and epithelialization occurring very quickly after the application of this modality. This is a very stubborn venous leg ulcer. This patient has had these wounds on again and off again for probably 10 years and finally with the application of pressurized oxygen, we got movement. We finally got movement to begin to close these ulcers. He couldn't believe it because he thought he was doomed for the rest of his life to have these wounds and by applying pressurized oxygen to these wounds, he now has hope. These pictures were taken a few weeks ago and they are just about closed at this point. And one last one, a big difference with just six weeks. This is a wound that had been open for years on a medial side of the foot. So it is a promising modality, something that we can add to our armamentarium. Hopefully, you all have a chance to look at it during the workshop and we can answer some questions for you at that point. Thanks a lot.
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