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Lecture Hall Wound Care | Treatment

Diabetic Limb Salvage: Advanced Options in Wound Healing


John Steinberg
John Steinberg, DPM
Assistant Professor
Department of Plastic Surgery
Georgetown University School of Medicine
Washington, DC
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Lecture Transcription
~1

Very briefly since I have no voice yesterday to give my talk, I'm going to go ahead and use this opportunity to give a brief overview of Diabetic Limb Salvage. We’ve had some great discussion thus far at the conference particularly on Charcot foot at a fabulous Thursday morning session for those of you that were there discussing and really having an open forum discussion on some of the challenging cases that we face particularly looking at Charcot reconstruction and diabetic limb salvage. I want to go through with you some opportunities and some interest; we check the slight advance there.

~2

On the identification of problem wounds and the concept here is to realize that these individuals fit into two categories. We have persons who were healing and persons who were not healing. We’ve had some discussion earlier about a wonderful paper in diabetes care that you can see listed at the bottom here at 2003 published by Peter Sheehan that really outlines for some timelines and trajectories to understand that every wound has a trajectory. And that trajectory is either towards non-healing or as towards healing. And what we should be looking for if you boil all this down is that when you’re taking your length times width measurements, it was not healing 10 to 15% per week and you’re seeing that patient on a weekly basis. When you get to the 3rd or 4th week and you’re still not seeing 10% to 15% healing, you need to step back and reassess this wound site and realize that you may now need to shift from the left hand side of the screen being basic wound care to the right hand side of the screen where this wound has failed basic therapy and you need to go into some level of advanced therapy technology. Now, there also is an opportunity at this point to step back and reassess the wound. You may need some rediagnosis for this wound. You may need some additional radiographic evaluation. You may need some additional biopsies or culture results that will help guide which we do it for this individual. But the reality is that you need to be able to reassess this and move on to the right direction.

~3

Wound bed preparation. This is the term that we’ve batted around a little bit already at this conference and the concept here is that we’re trying to establish a wound that is ready to move on to the next step. When the wound is ready to move to the next step, you would consider it prepared given the treatment parameters that you have established for it. So one of the mistakes we make sometimes when we prescribe some of these advanced technologies or therapies for wounds is we don’t necessarily have a goal or an endpoint while we’ve written that prescription or when we put them on a new dressing or when we put on a new kind of graft. We haven’t pre established in their mind. What it is that I'm looking for to declare this a success and know when do I move on to the next step? So that’s something that we need to identify and be able to move forward with.

~4

Bioengineered Alternative Tissues. This is the term that we coined just to kind of catch all the catchall term for what was becoming a great confusing terminology mix of skin substitutes and skin graft substitutes and bioengineer tissue. We didn’t really know what to make of all this, but you can really fit all this into this category when you talk about bioengineered alternative tissues and tissue generation.

~5

The science of bioengineered alternative tissue particularly looking at the living tissues during this discussion, I want to highlight some of the top process and what goes into the living tissue grafts apligraft and dermagraft, the cell therapy part of this is obviously what we’re actually trying to achieve. We’re receiving growth factors cytokines and natural antibiotic production from these living cells that we’re delivering or somewhat transplanting onto the wound. And I encourage on, we’ve certainly probably heard this terminology before that when you put on apligraft or a dermagraft and you put on a living tissue substitute or a tissue product, you have to think of this as a sheet of growth factors and a sheet of cells rather than a piece of skin. If you think this as a piece of skin, you probably going to use it at the wrong time in the wrong patient. If the wound is ready for a piece of skin, you probably should use a piece of skin and get a piece of the skin graft and heal the wound. We’re usually using these bioengineered tissues way before the wound is really ready for skin graft.

~6

The role of fibroblast in wound healing and the concept here is to understand that although we may like to think that we’re past this biology that we took way back when in undergrad in podiatry school, but the reality is that a lot of this does tie back to cellular biology and much of what we get from using this living tissue products comes from the human fibroblast. If we can deliver healthy fibroblast onto a wound that doesn’t itself have the ability to contain or produce or sustain healthy fibroblast, then we’re going to artificially stimulate healing in this wound site and you can see the products and the co-factors that are direct tributaries from a viable fibroblast. So again, the concept and a lot of questions coming about the platelet growth factors and such is the strong role for those in wounds. But if you truly think that it is a cellular deficiency or if you have some clinical evidence that tell you that you have dysfunction at the level of the wound on a biological level, then why would more of the same help the wound. We need to bring in something from the outside and that’s what we can do with this living tissue grafts.

~7

In particular, the bi-layer tissue therapy or trade name of apligraft this has four basic components, the surface are cornified layer which is exposed to air, the final manufacturing process actually contains keratinocytes as well as the epidermal layer. The dermal layer underneath is where the human fibroblast were found and that’s all seated on top of it and extracellular matrix which is bovine type I collagen.

~8

Now, early on this slide was used a lot by the manufacturers to show at the top kind of a cartoon picture but then at the bottom in a photomicrograph to show the product versus human skin and the similarities are amazing and they should be quite proud of the fact that they were able to reproduce what looks and feels somewhat like human skin in the laboratory using these tissue cell banks. But the reality is that this really is not the reason I use these products. If I need a skin, again, I would go to the thigh and I would take a skin graft and I would put it on the wound. The reality is that what we’re using this for as a biology of the fibroblast and the biology of the collagen and the keratinocyte that we’re delivering to the wound site, in my experience, you lose all if not most of this structure and this actual framework within 24 to 48 hours after applying the graft on the wound site. I don’t take the dressing off and find that there is still sheet of tissue and find a big slurry of cells and a mass of coagulant, but the reality is that’s still a viable successful graft patient. You just need to let that sit there and do its job for 3 to 4 weeks.

~9

The characteristic of bi-layer cell therapy again, this is neonatal cell, it’s not fetal. People get very anxious about this from vorted tissue or is there an ethical boundary here that’s been crossed. This is neonatal. These are healthy kids that are out running around playing basketball today who have had a circumcision and their tissue rather than being thrown to pathology is taken to the cell banks and used to generate this large cell banks and they have harvested a total of 10 to 15 graft in order to keep this cell banks viable. So, there’s very minimal ethical concern here. We have cells that are producing cytokines, matrix proteins, antimicrobial peptides and complex epidermis which are generated from the wound margins.

~10

Some of the FDA clinical trial data for this and efficacy, and in particular looking at apligraft, these are venous leg ulcerations greater than a year duration. This is where you really start to see some of the benefit using this product in your most difficult hard to heal patients at 4 weeks, 8 weeks, 12 weeks and 24 weeks seeing a significant difference of the control group and the active group healing almost 50%.

~11

In the diabetic foot ulcer clinical trial for the FDA, this showed a significant lower rate of osteomyelitis and those who received the bi-layer cell therapy.

~12

And this has open up a whole new clinical venue of these patients for wound healing. I share with you a clinical example here of a patient obviously have an aggressive foot infection traversing from the plantar spaces into the dorsal spaces involving the first ray but obviously also involving significant portion of the dorsal soft tissues.

~13

If we were to evaluate this and debride it, this ended up for a complete disarticulation of…

~14

The first metatarsal and the first ray. We then progress to negative pressure therapy and hyperbaric oxygen to stimulate a deep tissue coverage for this patient and then progress on the bioengineer alternative tissues.

~15

So once we got to a mostly healthy granular bed and had most of our deep tissues covered, we then progress on to the bi-layer of self therapy. You can see the migration from the wound margins.

~16

We applied our second graft at the five week post grafting mark and a third graft…

~17

Was finally used to heal this patient.

~18

Negative pressure wound therapy can be used in conjunction, it’s not necessary when you’re talking about bioengineered tissues but certainly can be used in conjunction. Great study here published in Lancet at 2005 by Dave Armstrong and Larry Lavery that showed the role of negative pressure wound therapy really is in that wound bed preparation. It’s in preparing the wound to move on to the next step increasing the rate of granulation tissue and the rate of healing.

~19

Some early experience with us at Georgetown with negative pressure wound therapy when we initiated this for our patients in comparing to control, we found that we decrease the length of stay on average by 3 days for our inpatients and those who were receiving negative pressure wound therapy as part of their comprehensive surgical plan as opposed to those who were not, we decrease our rate of cross contamination. Doing dressing changes on the floor can be a very hazardous type of procedure versus every 3 to 4 days with the negative pressure therapy system, you’re decreasing that chance of cross contamination. And we also have been utilizing this very significantly at our surgical closure site in BK and TMA amputations and have a significant decrease in our dehiscence and re-infection rates.

~20

Couple of clinical examples here with a 39-year old gentleman plantar ulceration obviously of a mechanical nature. If we don’t deal with the mechanics, it doesn’t matter what biology we throw on top of this wound we’re going to continue to fail. So this particular gentleman we can see his x-rays.

~21

No real significant concerns here but he…

~22

Had functional equinus is that all kinds of topical wound care with no real improvement to the wound and then finally…

~23

Upon progression, you can see what debridement and casting was able to get for so we got a healthy granular wound bed with adherent wound edges and we’ve got it to where its clean enough now that we feel comfortable proceeding to the operating room.

~24

This is a gentleman that we did a debridement percutaneous tendo Achilles lengthening applied after graft and put them into a splint.

~25

His post debridement culture shows no growth so we have a healthy wound bed without significant contamination and he healed rapidly in the next couple of months. Mostly due to the mechanical correction that we achieved from the tendo Achilles lengthening, but since we had such a chronic wound site, I felt that we need to give this someone of a biologic boost and that’s what we did by using the bi-layered living cell therapy.

~26

No Audio

~27

Another example here, we have dorsal and plantar wound status post incision and drainage, however this IND was incomplete because there’s a residual osteo of the 4th and 5th ray. We debrided this as you can see in the right hand photo to the point of a partial 4th and 5th ray amputation.

~28

Progressed on for kind of a comprehensive approach here for how we’re going to save this foot, counseling the patient that probably a TMA would be indicated here but if you want to try and save as much of your foot as possible, we certainly can attempt with some biologic tissue augmentation and what we did first was Integra with negative pressure wound therapy progress on to apligraft and then…

~29

Progressed on to a split thickness skin graft. So we kind of use all these products to prepare us for the next one. Integra to Apligraft to split thickness skin graft.

~30

Real briefly on diabetic foot infection, important to distinguish between a closed diabetic foot infection or mostly a cellulitis versus an open diabetic foot infection or oftentimes a deep abscess or an osteomyelitis. Closed infections are usually responders that are rapidly responding to an antibiotic course, however, obviously having to distinguish those from a necrotizing fasciitis or some type of a true gas gangrene. Open wounds are generally more chronic. They’ve been exposed to multitude and number of organisms that are present and this can be significant challenges because of the need for a stage approach. We generally can't take a wound that’s been open for two years, take them to the operating room, and cut up the metatarsal head and suture close the wound. We’re going to end up with a massive dehiscence and probably an abscess that was created like closing that wound. So we stage these procedures in combination with the…

~31

Appropriate antibiotic therapy you see during a 3 to 5 day spacing between the debridement and the closure. Systematic approach to diabetic foot infection here obviously…

~32

A rather important part of what we’re talking about and it’s important when we’re looking at diabetic foot infection to distinguish and prioritize between infection and ischemia. If you don’t have this thought process as your initial screening step when you’re going through this patient in the emergency room in your clinic, in the office, in the hospital bed, you have to be able to prioritize this, this is a major medical legal risk factor in dealing with the diabetic foot. A number one reason, a podiatric physician or surgeon will get sued but for a diabetic foot case is failure to consult a vascular surgeon or failure to intervene early with revascularization in these patients that end up with proximal amputation. You don’t want the evidence to come back and look for your chart to say that we think we could have prevented this below knee amputation that resulted from your care if the physician had gotten an earlier vascular consultation. It should be part of your initial work up for this patient a non-invasive vascular exam and if that shows any concerns, then they’re moving for an angiogram and a vascular surgery consultation. There are many situations where any gangrenous forefoot.

~33

We will wait until the revascularization has been completed before we do any debridement. As long as there is no infection threat, we’re concern for abscess. We talked of Thursday about culturing and I thought I would throw this slide up for you just to back up what we had talked about of the concern of how important cultures can be or sometimes how misleading cultures can be and how they are taken.

~34

This is a great study that was published in 2004 in diabetes medicine that looked at 60 infected foot wounds. Two cultures were taken from every wound. One was a superficial culture taken prior to debridement which we generally said was a bad idea and one was a deep culture taken after the debridement which is generally what we said was a good idea. The concept here in these individuals was I found that the swab and the deep tissue cultures were identical only in 62% of these cases which meant that a swab contain all organisms plus that contaminants 20% of the time and the swab failed to diagnose the deep actual organism, another almost 20% of the time. So if you rely on superficial swabs to guide your antibiotic therapy, you’ve got a 40% chance of being wrong with what you’re actually treating this patient for, so deep tissue biopsy and culture swabs are what are scientifically indicative for this patient.

~35

The Infectious Disease Society of America has established some pre-significant guidelines for the use of antibiotic therapy in the diabetic foot, I encourage you to review this if this makes a significant part of your practice. They have established the criteria for mild, moderate or severe infections looking at what medications orally and parenterally can respond to this therapy.

~36

There is some distinction and some concern of a lot of piptasor or Piperacillin in combination which is better known as Zosyn by its trade name versus some concern for Ertapenem which has come out for a little more recently. It’s a once a day drug that has certainly a significant indications for the diabetic foot…

~37

And have a great FDA trial showing their relevance and importance. I’ll share with you a quick clinical example here of a patient that really drove home the message to me of just how severe and how rapid the changes can be in diabetes for foot infection. We oftentimes have this tendency to disbelieve our patients. And a patient comes in the ER, they say, oh they got a horrible malodorous foot with drainage and gangrene and just to looks like it’s as a disaster for of a train wreck that’s probably going to lead to an amputation and he say, I’ve only had this for 3 or 4 days. In the back of your mind you’re thinking liar, liar, and liar. And in reality it can be true. Although many of those cases, the patients are in denial and then at the cases they don’t have a good visions so they don’t see the infection. They don’t come to the hospital soon enough and because of neuropathy as we know, they don’t have the pain that we would expect them to have from that infection. But I’ll share with you one example, this patient came into our clinic longstanding diabetic patient with neuropathy. He said prior concerns and prior ulcerations and prior cellulitis all responded well to outpatient. He comes in with this infection that the slide doesn’t really do a justice but he has got a cellulitic foot. He’s got fluctuance on the bottom of his foot. He’s got some fever and chills and we explain to him this is very different from your previous infections. This is a emergency. You need to come to the hospital this time. You need to be admitted today. We’re going to operate tonight. We’re going to try and save your foot. But you may end up with an amputation. This is a bad infection coming from this somewhat nondescript ulceration. Patient refuses, refuses, refuses. We spent 45 minutes going over the AMA guidelines and the fact that this gentleman is if he leaves the office, he’s leaving against our advice and we just couldn’t get through. We tried, we tried again, we couldn’t get through. And I finally gave up and I said, you know what, you know what the risk is here sir, you know what we’ve advised you to do, you may against that, I can spend any more time with you, I’ve got to move on to the next patient. And we wrote him what he requested, what’s his prescription for his Cipro clinda. And we’ve explained to him please come to the ER as soon as you can so we can get you admitted. This gentleman showed up four days later in emergency room. And this is what his foot look like.

~38

And to me this was rather dramatic. I know this going to get worse. I know he was going to end up to the point that he probably would up on amputation. But I didn’t expect to see this amount of change over four days. So this kind of reaffirmed my belief in some of those patients who, say it’s only been there a few days only a few days. It can go from this to this in just a matter of days. And of course this patient progress on to below knee amputation.

~39

Real briefly, I want to talk to you, I mentioned there was a great study done in regards to Ertapenem. The concept here is what was called the side step study. This is led by Ben Lipsky who’s a real pioneer in the IDSA in the diabetic foot world. This is a large study 473 specimens that were obtained that base line looking at cultures, looking at patients.

~40

The primary endpoint was to compare the clinical efficacy of ertapenem versus Pip-Tazo at the point of discontinuation of IV therapy and secondary this was to look at follow-up after they…

~41

Were on Pip-Tazo if indicated. This was a randomized double blind control trial with 586 patients enrolled in randomized. They received ertapenem one gram q. day versus Pip-Tazo 3.375 every six hours. They were classified according to the UT system and additional radiographic and a clinical test were utilized.

~42

To sum up all that, in one slide for you is the story that we have, additional clinical options for us oftentimes ertapenem 3 can be a more convenient, a more cost effective, those schedule for your patient and they prove that they were at least clinically sufficient and equivalent to the Pip-tazo every six hours. So we’ve got additional options that are evolving for us in…

~43

treatment for the diabetic foot. Prevention of recurrence is a large, large challenge. We talked about this earlier with talking about patient compliance and denial and progressing with care against medical advice. These patients need appropriate patient education. We don’t necessarily always have the time to do it, but we are the best suited provider to inspire them to do it. If we can get these patients to believe that they can make a difference in their disease, then they’ll go on to seek the appropriate education that we can point them towards accommodating the deformity obviously we’ve talked about that and recognizing the actual true…

~44

And appropriate etiology of the ulceration. Thank you very much.

Dr Steinberg discusses the use of advanced wound treatment options for diabetic limb preservation. Dr Steinberg reviews concepts of basic wound care and advanced wound care, emphasizing the appropriate timing of each. He then discusses several specific advanced wound care modalities including bilayered alternative tissue, negative pressure wound therapy, and the appropriate treatment of infection.
Goals and Objectives
After participating in this activity, the viewer should be better able to:

1. Identify the difference between good wound care and advanced wound care.
2. Choose the appropriate advanced wound modality at the appropriate time.
3. Assess the concept of wound bed preparation.
4. Appropriately treat diabetic wound infections.

Estimated time to complete this activity is 30 minutes.
Target Audience
Physicians, diabetes educators, and other health care professionals who treat patients with diabetes.
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Diabetic Limb Salvage: Advanced Options in Wound Healing
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Diabetic Limb Salvage: Advanced Options in Wound Healing
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Disclosure Information
Diabetic Limb Salvage: Advanced Options in Wound Healing
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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 individually sponsored or jointly sponsored educational programs. All faculty participating in any PRESENT e-Learning Systems 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.
John Steinberg, DPM has no relevant financial relationship(s) to disclose.
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Diabetic Limb Salvage: Advanced Options in Wound Healing
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In this section of our Privacy Policy, we discuss the security measures we take to protect information that we have collected about you.

We have implemented technology and security policies, rules and other measures to protect the personal data that we have under our control from unauthorized access, improper use, alteration, unlawful or accidental destruction, and accidental loss. We also protect your information by requiring that all our employees and others who have access to or are associated with the processing of your data respect your confidentiality. We use security methods to determine the identity of its registered users, so that appropriate rights and restrictions can be enforced for that user. Reliable verification of user identity is called authentication. We use both passwords and usernames, as well as double opt-n verification, to authenticate users. Users are responsible for maintaining their own passwords.

Access to Information and Choices

In this section of our Privacy Policy, we tell you how to obtain and correct information we have about you, and how to choose what types of information you may share with us.

Correction of Information We Have About You

If you believe that registration information collected by our Web site(s) is in error, you may edit your personal profile any time that you like. You can directly edit most of your user profile on the Web site on which you initially registered. Information that you can not edit may only be changed by contacting Web Customer Support (see CONTACTS). Requests for deletion of your record may result in your removal from the registry, but we may keep certain demographic information about you for product improvement purposes. You may contact Web Customer Support and ask for the changes that you would like to make.

Our Employees

Our employees are required to keep customer information private, as a condition of their employment with the company. Only selected, authorized employees are permitted to access personal information. Our employees with access to personally identifiable information are required to attend a confidentiality/privacy training class, and to sign a confidentiality agreement. All employees and contractors must abide by our Privacy Policy, and those who violate that policy are subject to disciplinary action, up to and including termination of their employment and legal action.
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