Robert Frykberg, DPM, MPH reviews the basic principles of good wound care. Dr Frykberg defines a protocol for diabetic foot ulcers and reviews advanced therapeutic agents to achieve the goal of healing the wounds.
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Robert Frykberg, DPM, MPH,
PRESENT Editor - Diabetic Limb Salvage
Carl T Hayden VA Medical Center
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I am speaking in lieu of Dr Ross Talarico, who came down ill this week, and could not make the meeting unfortunately. So I�m kind of filling in, providing his topic, which was Advanced Wound Care Modalities � when do we use them?
So my topic will be on timing and protocols. I need to give disclosures � consultant speakers� bureau, research support for a number of companies. This talk is sponsored by Advanced Biohealing.
So we had to forego the, I think, a basic lecture on epidemiology of diabetic foot disorders, �cause it really sets the stage for the magnitude of the problem that we all face on a daily basis. And those of you who do a lot of diabetic foot wounds and take care of a lot of these patients know what I�m talking about. It�s a very serious, very difficult problem.
We know that diabetic foot ulcers are the pathonomonic classic lesion of the diabetic lower extremity, going back several centuries if you look at all literature like I like to do. We do know that diabetic foot ulcers are a multifactorial etiology. There�s approximately a 15% lifetime risk for foot ulcers in the overall diabetic population. We know that the multifactorial causes of foot ulcers can be very briefly simply classified as either neuropathic, ischemic, or neuroischemic. And that�s the very basic, that�s the simplest way to classify things. And I like to be simple with classifications, �cause I think a proper classification really does help to facilitate your management.
We know from several very important studies in the literature that diabetic foot ulcers are the precursor to diabetes related amputations in about 80 to 85% of diabetes related lower limb amputations. So what this really means is that you know from Riber�s 1999 study that foot ulcers, non healing foot ulcers, are in the pathway leading to those amputations in about 80 to 85% of diabetes related lower limb amputations. This does not mean however that 85% of diabetic foot ulcers go on to amputations. That would be absolutely horrible. But when you look at an amputation, you can bet your boots pretty much that a non healing ulceration was in the pathway that led up to that tragic event.
So we know from the prior speakers that principles of wound care are really basic, and if you try to simplify things it makes a daunting task somewhat easier. So we know that with our patients we need to properly evaluate them and provide for medical management of the comorbidities. So if we properly and thoroughly assess our patients and their wounds in their lower extremities, we can pick out these important metabolic parameters that are disturbed in the diabetic lower extremity. And when we find these problems we address the problems. So of course we provide for multidisciplinary medical management � these people are sick. We provide for vascular intervention, because a large proportion of our diabetic patients now present with foot ulcers that are of neuroischemic etiology � far more than 30, 35 years ago when I started. So we need to look for vascular impairment, and by looking for it you will find it, and our job is to look for unrecognized ischemia, because you know many times a non healing diabetic foot ulcer is the first presentation of chronic lower limb ischemia or sometimes called critical limb ischemia. So you need to look for it, and when you find it, you get your vascular referral and you get that problem corrected.
We also recognize the role of infection. We�ll be talking about infection later, but one of the other reasons why these wounds remain chronic for such a long time is underlying occult infection or osteomyelitis that�s been undiagnosed, or even chronic heavy bioburden can prevent this. So hence we need to be sure that we drain underlying abscesses if present.
We need to provide for aggressive debridement to remove necrotic tissue, and subsequent bioburden. So you need to look for these problems and correct them, and if a wound is clinically infected, you treat that with antibiotics. Sometimes even when it�s not clinically infected but let�s say it probes the bone, you have suspicions for clinical osteomyelitis, you need to treat with appropriate culture directed antibiotics. We�ll talk more about that later.
Once you�ve done the full assessment, then you zero in on the wound care itself. And wound care, as I�ve already mentioned in part, consists of debridement, wound bed preparation as Dr Grady and Dr Molder have discussed. An essential part of your care is always offloading or for venous ulcers, obviously, compression. Then we consider therapeutic agents � things that we want to put on these wounds. And I believe that surgery is an essential part in the overall care for these chronic diabetic foot ulcers. Some people would consider just incision and drainage or debridement, surgical intervention, but also bone resections, joint resections or even amputations are part of the overall protocols that we use to treat these chronic wounds.
So we know there are a lot of advanced therapeutic products that we see out in the exhibit hall that we use all the time, but we have to rely primarily on good standard wound care to initially manage our wounds. Good basic wound care is always job number one. Then you can starting adding the advanced therapeutic products when you see the good basic wound care, as we�ll see in four weeks, if it does not progress properly with a 50% reduction in wound size, then you move on to your advanced therapeutic products. But you never neglect the good basic wound care that we�ve already discussed.
So then the question remains, when do we need to consider advanced therapeutic agents? When do we need to use these? And that�s a very important question, �cause it comes up with every patient. And then if we do use these, we have to closely monitor the patient�s subsequent progress, because we know that these patients do not heal on an upward trajectory. There�s many peaks and valleys all the time. There�s always problems, we need to address these problems and respond to the wound as it presents to you each week. And each week it can certainly change, so you need to be aware of that. You constantly have to monitor these wounds.
And also the question remains, when do we stop using advanced products, or how often do we need to use the advanced therapeutic agents? So many of you have seen this diagram for the most part put forth by Peter Sheen in 2003, put forth by Andrew Bolton in his New England Journal paper that Dr Molder had referred to earlier. Basically it states that we provide that good wound care, the basic tenets of wound care always remain the same. And you observe the patient for four weeks. And if you can see healing at 50% or greater at four weeks, then you just continue on with the good basic wound care, �cause those patients have a predictable response, meaning that those people are more likely than not to heal, let�s say at 12 weeks.
However, if you do not see a response of about 50% within four weeks, then you need to step back and reconsider what are you missing. Have you missed underlying ischemia? Have you missed underlying osteomyelitis? Have you inadequately debrided these patients, or are you inadequately offloading them? Are they malnourished? Is there some other issue? Is it a malignancy? Do we need to do a biopsy of these wounds? So you need to step back and see if the patient�s not responding the way they should. You step back,
reassess, and if your reassessment shows no hidden variables there then you want to consider your advanced therapeutic agents to help stimulate that healing, as we�ve heard.
In 2010 Bob Snyder published a review, a consensus document, on, it was an update guideline towards good wound care. And they really felt that the use of advanced modalities, when indicated, should be viewed as a new standard of care. And they shouldn�t be considered as a last resort. And in our center we do not consider advanced therapeutic agents as a last resort. We consider them as an early adjunct to good basic wound care, because we are in a VA system, with very very difficult, very very sick patients that don�t always present with that beautiful healthy neuropathic wound in a well-perfused foot. In fact that�s more the exception than the rule. So we tend to use our advanced therapeutic agents very aggressively and much earlier than would traditionally have been used.
And several reports and abstracts in the literature have certainly supported this role that we�ve embraced, which really is early and aggressive treatment will reduce the long term costs of not using them to treat these patients. Several studies, whether it be with negative pressure therapy or different types of tissue substitutes or what have you, show that the costs are loaded up front with using these advanced therapeutic agents. And that the savings come in the long run by avoiding hospitalization, surgery and amputations. So based on this, and based on several other studies, we tend to use things earlier and aggressively to keep people out of the hospital. Obviously we�re not always successful, but that�s the position that we take.
So what kind of advanced wound care technologies do we use? We use numerous � every one of these different agents we�ve used at some point in time. We tend to rely very heavily on our cellular based tissue products especially our human fibroblast derived dermal substitute, the Dermagraft product. We also use several different negative pressure devices as well, depending on the size of the wound. We use other of these various topical wound care therapies, all of them are used in clinical practice, few of them really have any Level 1 studies to support their use. But they�re still useful depending on the type of wound that you�re dealing with.
We also like to pay attention to the evidence base. This is just an interesting graph I developed a couple of years ago looking at the percent improvement over control groups for published peer-reviewed randomized control trials. Looking at the studies in comparison to total contact casts, which I think most people would agree is almost this gold standard for healing wounds, but mainly it�s healing neuropathic wounds.
So if we look at these, this was with Granex, this was the Apligraf trial, a graft jacket trial, published several years ago. This was not really fair, it�s on an oasis venous leg ulcer trial. And then we look at the human fibroblast derived dermal substitute, the Dermagraft product. We see varying rates, margins of effect compared to the control population in the period we�ve studied. And so we used this with 64 or 67% margin of effect, it�s the highest in Dermagraft compared to controls in any other study. So we use this as our rationale for why we use the product that we use, so freely on our really difficult wounds, because the evidence supports the efficacy when comparing it to good standard wound care. But it was just an interesting comparison when you look at populations � you really want to look at intent to treat populations in randomized control trials, not retrospective studies, not just prospective uncontrolled studies here, so, very interesting to see. All of these are published,
but it just turns out that the Dermagraft has the highest marginal effect, even though I have a lot of criticisms for the clinical trial from which this data was derived.
Some of you might have seen this. It was an algorithm put forward by Howard Kimmel some years ago from the Cleveland VA, looking at low risk patients versus high risk patients. Those of you who were in the workshop this morning saw this same graph. This was also published in the journal of diabetic foot complications, I think it was last November, October, November. Basically what it�s saying, in the high risk population when you have patients with prior amputations, prior history of ulcers, renal failure and marginal levels of ischemia, we tend to rely early on these advanced products earlier, rather than waiting for a longer period of time. And I think this fits our model perfectly, because we tend to aggressively use a number of advanced agents, usually in concert with one another, earlier rather than later, and really that�s the message here.
So our general standard of care embraces this four-week rule, where we�re looking at four weeks of good standard therapy, looking for a 50% reduction in size of the wound. And if we reach it then we continue with that. If we don�t see that we�ll start our advanced therapy earlier rather than later, and we use the human fibroblast derived dermal substitute, and we usually use it in concert with other therapies. So we freely use multimodal therapies � in fact, that�s more the rule than the exception in our center.
We use generally four weeks of advanced therapy, and if we continue to see improvement we�ll continue with the therapy. If we stop seeing improvement then we step back and reassess again. So, and also we evaluate every week. Some weeks I say, �No, that wound is too soupy, there�s too much drainage, it looks infected � let�s hold off on this until we clean it up.� So you constantly have to be reassessing your wounds for progress, and if you fail to see progress or you see a problem, you stop, you go back to basic wound care, and then when circumstances are correct you move forward.
So what agents do we use? You can see we use all of these agents. They�ve all become a very important part of our wound care protocols, plus we�re also using some amniotic membranes, PRP gel, Becaplermin once in a great while, collagenase and multiple types of dressing. So we use multimodal therapies. We use a lot of different products, depending on the circumstances at hand, depending on what type of wound, what is the characteristic of the wound, does the patient have ischemia, renal failure, how chronic it is.
So these are just some case examples of some difficult wounds that we�ve had. A patient with, comes to us with really a trashed forefoot after having a proximal vascular procedure that was frankly, was not optimally done and didn�t work as many of these grafts do, it went down, so we had to perform a TNA. He had a chronic wound on an old ankle fracture. This was a piece of the Pegasus product, equine pericardium, that we saw in the last lecture. This piece of pericardial graph lasted longer than the company did, because this was on for several months, and the company had subsequently folded. But as we often see in our patients, especially ischemic patients, the flaps on our amputation sites go down, and then as you surgeons would know, that�s when your heart sinks, where you get Hershey squirts or what have you and then you have to say, �Okay, now what am I going to do?� So then what we have to do is go back to the operating room. Here we put on a bilayered matrix silicone covered dressing here, over the exposed bone, and we use negative pressure of course. Here we use the Dermagraft application. This was a movie but you�re not going to see it on this slide. And we healed up this wound here eventually with the equine acellular
graft, and we finally got this patient to heal. The important thing here is that you can see, well, we spent a lot of time and effort on this. However, we�ve kept the patient out of the hospital. We�ve kept the amputation at the same level that it was initially done, and I think that�s the value of using these advanced agents early and aggressively, avoiding further hospitalization and amputation.
Here�s another person who had has ischemia bypass, the bypass was only partially effective, we had to do a proximal midfoot amputation. We noticed a nice big dehiscence here, but the wound quality was not so bad with that dehiscence, so we used negative pressure therapy. We used the fibroblast dermal product here on the wound with continued negative pressure therapy, and we were able to effect a final resolution of this, keeping the patient out of the hospital, and a very sick patient with some residual ischemia. So by using the products in this fashion, we are able to effect final closure and still keep the patient out of the hospital, thereby putting the costs up front with the costs of these products, but in the long run we�re saving a lot of money and resources by not having to bring that patient into the hospital. That�s really the message that we�re trying to promote in all of this.
So in summary, multimodal therapies are most consistent with current clinical practice, and as I�ve said several times, earlier is always better. Also remember that your wounds change over the course of treatment and you need to be prepared to change your therapy as the wound characteristic change. We always pay attention to the basics and we constantly are reassessing our patients as necessary. And remember the four week, eight week rule, four weeks of good therapy and add your products. If you haven�t had eight weeks resulted in good wound closure then you need to step back and reassess.
So thank you very much. I think I�m a couple of minutes later. Thank you.