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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Mark Couture, DPM
Central Texas Prevention of Amputation for Veterans
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Male Speaker 1: This morning, I’m going to talk to you about my retrospective study I did with cryopreserved umbilical cord. We’ll talk a little bit of biology upon the product too, but just a quick [indecipherable] [00:10] slide based on this conference. As far as what we want to learn today, we want to learn about basic scientific actions that cryopreserved umbilical cord has for helping to mediate the response or effectiveness of the tissue. Describe the procedure as far as utilizing this tissue for chronic ulcers for the foot and ankle. Also want to talk about design for my study, that is 60 month retrospective study at the VA, and just looking at real world effectiveness of using cryopreserved umbilical cord. Then, I’ll go over a couple of case studies that I put together. So, cryopreserved amniotic membrane and umbilical cord tissues, I’m told like I mentioned this one time. The product is NEOX CORD by Amniox Medical. Hereafter referred to as cryopreserved umbilical cord. There’s three different versions of it here. We’ve got the 100 version, which is the cryopreserved amniotic membrane, the CORD, which is the 1K product which is thicker due to deemed amniotic membrane and umbilical cord. They also got a particulate form called the FLO that has the umbilical cord and amniotic membrane as well. So just discussing the fetal wound healing. Fetal wound healing is scarless. Fetus heals with regeneration without inflammation and scar. The tissues for fetuses have innate regenerative properties. Amniotic membrane and umbilical cord, of course, are fetal tissues, so they differ from adult tissues because of their immune modulators. Amniotic biology is not equal to adult tissues. However, the innate regenerative healing properties of these tissues are preservable and transplantable. So everyone is familiar with the wound healing cascade. When you get stuck in that inflammatory stage, that’s where your wounds will stall out, so we got to get out of that cycle. Transition from a fetal regenerative healing type to scarring type is what adults do. I mean, that just depends on how much inflammatory reaction is going on at the wound site, so less inflammation, more of a regenerative healing type. When there’s a tissue injury or a wound, we’ve got the three different outcomes here. You can either have deficient healing or nonhealing wound, where you get chronic inflammation. You can get repair and scar formation, which is what adults do, or you can have regeneration, which these tissues help to do within the wounds that we treat. Amniotic membrane and umbilical cord modulates the inflammatory response. Just making this as simple as I can, more for myself, not for all of you. The effect of inflammatory cells is an increase in cell death for the proinflammatory cells. They decrease the proinflammatory signals and increases anti-inflammatory signals. If you decrease inflammation, you get the fetal wound environment, and then you get regeneration instead of scarring. Amniotic membrane and umbilical cord, again, are fetal tissues that are electively donated. Tell my patients this, some of them have issues sometimes with, they want to know if it’s from aborted babies, and it is not. Anyways, amniotic membrane and umbilical cord matrix contains a unique biology that’s not in adult tissues. These modulate in the chronic wound environment by basically lessening inflammation. When my oldest daughter was younger, she used to go on my shoulders when we’re at the zoo. Instead of holding on to my hand, she’d hold on to my hair and she direct me which way to turn with my hair. I say that because I liken that to getting IRB approval at VAs for research studies, because that’s how it feels. Anyways, I did a 60-month retrospective study in my facility using this product, because I’ve been using it for about three years now. All of my wounds were foot and ankle. In my facility, we’ve got a wound clinic that typically treats the venous ulcerations, so most of my wounds are foot and ankle. Of course, I want to see how effective the cryopreserved umbilical cord was for my patients for these chronic wounds in the VA population. A lot of you here are familiar with some of these data on here. I’m not going to touch on them. Really the slide should be prevalence of lower extremity ulcerations, not light ulcerations. Again, the take home from this is that ulcerations associated with diabetes, most common cause of foot and ankle ulcers. Studies done that say that 15% of diabetics will develop a DFU during their lifetime, and that the DFUs are responsible for about 80% of all diabetes-related lower leg amputations. The inclusion criteria for my study was, of course, anyone that had a confirmed diagnosis of a foot and ankle ulcer, confirmed application of the cryopreserved umbilical cord. Always took the measurements as far as length and width to get your square centimeter, and then of course, identifying the number of applications that were used for these patients for their wounds.
Exclusion criteria, I’ll touch on a little bit here and expand upon. I always felt like when you’re doing a study, that you can include patients that are lost of follow-up because you don’t know the results, so we had to exclude those. The other one were significantly noncompliant patients. So, if you had someone that’s removing their dressings or they’re taking the tissue off, if they’re not following offloading instructions on a consistent basis. My favorite one is the guy who took out his total contact cast with a small pocket knife and then tried to gift it to me at the next visit. I also excluded patients that developed an infection that led to a major or minor amputation. Now, that might be controversial to some because, of course, amputations can happen for any of these patients just because infections can develop within the wounds. But I decided to exclude them because I think it’s more of part of their disease process versus any function of the tissue that we put on. That’s why I excluded those patients as well. Just as far as endpoints and potential benefits, the primary ones is to measure what percentage of wound is actually completely closed. Secondary endpoints, times complete healing measured in weeks, number of product applications that were used, and then of course, correlated the number of applications to time the wound closure. Of course, potential benefits from the study we see how well the cryopreserved umbilical cord was for treating DFUs where they could demonstrate faster wound healing for some of these patients. As far as the demographics here, I had 57 patients for this study. I have at age of 66, all male, which is of course common in VA population. Many of these patients were diabetic with peripheral neuropathy. A lot of those comorbidities there that we see in the VA patients on a consistent basis, so no surprises there with the demographics or comorbidities. Here’s the data, so 57 patients and 64 total wounds. Fifty one of the wounds healed up for 79% heal rate. The initial wound area you see there was about almost 7 square centimeters. What I found was that exactly about 3.4 applications with an average healing time of 5.5 reach for these patients to heal, which I thought was pretty impressive. Again, taking into account the inclusion/exclusion criteria, those are the numbers that we got. Even if you subtracted out the ones that had amputations, it still came to around 70%. Just mapping this out here in terms of weeks. At four weeks, as far as these healers, 51% of the wounds were healed up. Eight weeks, 80% were healed up. In the 12 weeks, 90% of these patients were healed up. Again, we got an average of about 5.5 weeks. Now, I should mention that I see my patients on a weekly basis for sharp debridement and reapplication. Sometimes at two weeks, if they can’t make it in, but generally, it’s one week. That’s always the process that I’ve done and I always tacked on my tissues with Mepitel. If I’m in the OR, I may suture it down. This tissue has thicker properties than some of the other amniotic tissues out there. It’s very easy to suture, good handling characteristics. But usually in the clinic, I just tack it down with Mepitel and see them weekly and reapply. Now, some of the bigger pieces may not be taken up into the wound over time, and so if they’re still present within the wound, I’ll debride wherever the wound is open and then just redress and wait for it to all be taken up before reapplying. First case study here, 67-year-old patient who’s actually not diabetic, had a incision and drainage surgery because of the abscess on top of his right foot. Large initial wound, 11 x 4 centimeters. Started him on Santyl initially when he came to the clinic for followup just because of trying to promote a little bit more granular base because he had some fibrotic material, started the cryopreserved umbilical cord application. That first slide you see there is not fibrotic slough. That’s actually residual amniotic tissue, because the cord is thick. Since we had to use some of the bigger pieces on him, they’ll still be present within the wound usually after a week or two. But it granulated in pretty quick as you can see it there on the far right. He went on to completely heal after 11 weeks of treatment. These are weekly applications of the product and just seen for consistent visits. Just emphasizing some of those bigger pieces, if they’re still present in the wound, I’ve left them be as they may take two to three weeks to fully incorporate. I don’t disturb it. But, of course, if a portion of the wound is open, I will debride that open part of the wound.
Again, this patient healed up in 11 weeks with consistent appointments. I think if you see your patients past the one to two weeks [indecipherable] [10:10] for these ulcerations, you have more of a chance for complications to occur. The cryopreserved umbilical cord has been shown to promote granulation tissue on deeper wounds. I’ve used it actually over healthy tendon and bone and can be used all the way to full closure for the wound. Second case study, 62-year-old insulin dependent diabetic, malignant melanoma on the bottom of his right foot. It’s one of those areas that you don’t want an ulcer to be, right around the fifth metatarsal base, but that’s where his melanoma decided to show up. I did a wide excision in the OR with a large initial wound size, because I’ve happened to take 2 centimeter margins. His sentinel node biopsy was negative, so I did this in coordination with general surgery. Here’s just mapping out his 2-centimeter margins after marking the lesion itself, again, going to be left with a very large wound. I had to talk to this patient beforehand because, of course, some people would just give up on this and want their leg cut off because of all the potential wound management you’re going to have to do for this, so this could take months to heal. But, he was committed to it. Actually, his A1c wasn’t too bad but he decided to try to pursue wound care. Right from the start, I’ve talked to oncology and kind of sought their opinion on the use of the cryopreserved umbilical cord right away on this since his sentinel node was negative and they didn’t think there’s any reason not to. Anyways, here’s the wide excision. What I did in the OR right away was sutured in the cryopreserved umbilical cord, and he actually granulated in pretty quick. He had a pretty significant deficit. It was hard to tell just how deep the melanoma went just because of the dye that was present from general surgery doing their thing. Anyways, he granulated in real well. We offloaded him. I had to take him to the operating room about three or four times for thorough debridement. I used some of the particulate material to inject subcutaneously. Usually, at 12, 3, 6 and 9 o’clock, and we’d put the cord tissue on over this. So this patient went on to full healing over time and he was committed to the wound care, which is important on the patients done, because if they’re not going to follow what you say, I mean these things of course will go south. They’re pretty quick. But he went on to full closure and he stayed closed up. Points of emphasis as far as with this case here, I mean, you may need to take some of your wounds to the OR for adequate wound debridement. There are some patients of course that aren’t completely neuropathic. If they’re partially sensate, numbing it up sometimes doesn’t work well enough to do an adequate debridement. Sometimes, of course, you want a little bit more hemostasis control where you can get in the OR, so that’s what I do with this patient. Like what you said, are charged on the care facility just on campus so that it’s easy to take him to the OR versus being outpatient. The cryopreserved umbilical cord can be secured with sutures, held in place with a nonadherent wound contact layer. That’s just a long way to say Mepitel. Anyways, you can do it with Steri-Strips, whatever you prefer. Considering the particulate matrix, so one of the things that I’ve done lately is I’ve used some of the particulate matrix to sprinkle a little of the powder over a wound whenever some of the larger pieces of the cryopreserved umbilical cord are not yet fully incorporated. I’ll debride the open part of the wound, sprinkle some of the particulate matrix on there as an adjunctive treatment or sometimes inject subcutaneously. You can consider that for some of your chronic patients as well. Again, of course, advising your patients on potential benefits of treatment of course will get them healed and back on their feet, but also educating them that this may take a long time to heal. Again, there’s a commitment they have to make on their part that I always go over with them because a lot of these patients ask for how long is this going to take to heal. And tell them, “I honestly can’t tell you,” but that depends on how they compliant they are. Anyways, with this study here, I just felt like it was important to get out there. Because I knew product had worked well for me, I just want to see just how well it performs. The study is actually supposed to be going to publication with the next couple of months. I believe that’s the end of my lecture here. Yeah. Thank you.