Join Jeffrey A. Ross, DPM, MD to learn about his strategies for optimizing the wound environment. Dr. Ross will also share his case studies utilizing a Collagen/ORC/Silver-ORC dressing.
My name is Dr Jeffrey Ross. I'm here in the Baylor College of Medicine, where I serve as associate professor in the Department of Surgery and the Division of Vascular Surgery with E Save the Extremity Program. I'm going to talk to you today about diabetic foot ulcers and how we can help to heal these ulcers. Utilizing these snap therapy system as well as the palm, a gram Prisma matrix. We have a diabetic epidemic here in the United States. We also have a problem with childhood obesity in this country, which is leading to an increased number of young diabetics. As you will see later, we see a number of these diabetic cases which are in their thirties and forties, which is way too young for ah population. That's at risk. So the presentation today is walking through care and management of the diabetic foot ulcers, best practices for wound bed optimization. So here is some important information you should be aware of. So here are my disclosures. I serve as a consultant speaker for Casey I, which is now part of three m and I also serve as a consultant and speaker to life. That health We're part here at the Baylor College of Medicine in a limb salvage program entitled Save the Extremity Program. It's important that we are a multi disciplinary team and approach to saving lower extremity limbs. Objectives of this presentation will be discussing optimizing the local wound environment with diabetic foot ulcers. And as a pre Lim, I'd like to talk about the epidemic of diabetes in our population here some of the statistics that we want to know, such as. By the year 2030 the number of people with diabetes globally will rise to an estimated 500 million one million amputees globally in patients with diabetes every 30 seconds. Here in the United States, about 1200 amputees occur weekly 130,000 lower extremity amputations, or about 5.6 per 1000 adults with diabetes. Just as an informed, uh, note, this has increased dramatically, unfortunately to the 80,000 that we used to see in prior years. So the numbers, unfortunately, have increased once again, even with good wound care and with good multidisciplinary approaches, a few other fast facts the total number of people who have diabetes here in the United States average about 34.2 million. Here are a few other important factors. They're about 27 million people who have been diagnosed, or about 8.2% of the US population. However, what's more important is about 7.3 million of these individuals are undiagnosed, or about 21.4%. This is very important for those individuals who are undiagnosed and suffer some of the problems that we will see in later years. So what is pre diabetes and what are some of the statistics that we see in prediabetes? Number one? Pre diabetes is a condition regarded as metabolic syndrome, where we have, uh, insulin resistance where we have hyper lipid anemia and we see conditions such as end stage renal disease development. We see about 88 million adults aged 18 years of age or older who come under the category of pre diabetes. That's about 34.5% of the US population. For those individuals who are 65 years of age or older, we're looking at about 24.2 million adults as well who have pre diabetes. Now, this is a very important slide. Uhh. As many of You know, uh, wound healing is very important. And when wound healing is stalled, or as we say here, stuck in inflammation, we want to know. Why is this condition occurring? Well, if we look at the left, we see that cells to produce excess. Proteus is on the right. Damaged tissues occurred due to degradation of extra cellular matrix and growth factors. And then we have bacterial, Proteus is and toxins that occur toxins could be bacteria as well as Proteus iss. And then last but not least. And I think many of you have heard this term, uh, in the news these days Ah, side of kind and free radicals or increased inflammatory response. So how do we prevent delayed wound healing from occurring in the first place and prevent excessive? Proteus is degradation of these growth factors, uh, toxins from developing in these wounds and increased inflammatory response in wound healing. It's a known fact by Peter Sheehan that ulcers that failed to progressive worsen from weeks 4 to 6. We need to look at these wounds and those that fail to achieve 90% of resolution at week eight are typically not going to hell at Week 12, you can almost predict that. So if we see that a wound is not improving by four weeks, I think you need to really start over again. Look at retooling and see how you can improve this wound. We have an expression. It's called if a wound is now chronic and is stalled. Start again to breathe the wound and make a chronic wound and acute wound. It's a good little tidbit. So let's look at the topic of abnormal wound repair, particularly in the diabetic patient, where we see that wound healing is decreased and the elongation time of response is also increased. In those individuals. Abnormal wound repair will affect acute inflammatory response. Some of the categories that we will see will be increased. MMP counts, my insufficient sailor response and poor Veysel Dilip Ation. Obviously, in the diabetic who may be suffering from peripheral vascular disease or are immuno suppressed, they're gonna have poor profusion of those tissues and poor options in tension. As a result, they're going to have inadequate regulation response, and that's going to cause dysfunctional fiberglass. Due to the low interest sale of glucose and last four deposition of extra cellular matrix. As I mentioned, collagen synthesis is dependent upon oxygenation, oxygen, tension and profusion. In the cases of many of our diabetics, due to micro angio, pithy or due to peripheral vascular disease, they're going to have low oxygen tension. And that's going to affect wound healing. So looking at the stalled wounds or the wounds not healing efficiently, let's look at re balancing the wound. Environment number one. We can look at maintaining moist wound environments. We can reduce the microbial burden, the bio burden, as we call it, decreasing those biofilms and last but not least, lowering the Proteas and free radical activity. When we do these three things, that's going to now optimize our will management, thereby stimulating room healing. So let's look at Proteus is for a few moments. So what are Proteus is well, Proteus is number one of proteins, but their degradation enzymes. There are two categories of Proteus is there The Syrian Proteus is such as the last tastes. And there are the matrix. Mattel. Oh, Proteus is such a Z m m p s. So let's look at Proteus is and chronic wounds. So the left. We have inflammatory Proteus activity and to the right. We have the time frame in days, weeks and even months. So when you look at a normal wound healing process, we're talking about a wounded day zero, whether it's just been debris did and usually at about day three, we'll have. Maybe an increase of Proteus is, but to a slight lower extent. And then a day seven, we see the bell curve dropped significantly where the Proteus is drop in number and the wound healing really goes on into resolution. However, in the stalled non healing wounds, we see an increase inflammatory Proteus activity to a great level. This level is such a significant level that it's going to cause these non healing wounds to go on in time well past a week, well past weeks and even months of non healing. That's where we know that something needs to be done to improve the wound, to maybe go back to develop a acute wound and decrease the Proteas level. So Proteus is are in excess and non healing wounds. The inflammatory Proteus is obviously predominate, and we talked about the two different types of Proteus is a moment ago, such as the last days and such is the M. M. P s. When we look at Proteus activity, we see that there's a great number of a last taste. 40 aces here on the left side in all three types of wounds, whether it's a Venus leg ulcer, a diabetic foot ulcer or a pressure ulcer. But the MPs or slightly decreased compared to the last cases in the three types of wounds as well. Now, when we look at em MPs and we look at chronic fluid, we see that the MPs number 123 and eight and nine go up in level with this chronic fluid accumulation. So when we have biofilms where we have fluid accumulation, where we have infection, we're going to see increased M. M. P s. So what are the features of palm A gram prisoner matrix? They're comprised of a sterile freeze dried composite of about 55% collagen, about 44% oxidized regenerated cellulose, or O R. C, and about 1% silver. RC silver O. R. C contains about 25% with ironically bound silver, better known as a very, very strong anti microbial agent. So let's look at the sacrificial substrate story. When a tissue injury occurs, whether it's debris, mint or trauma injury, collagen is going to be replaced by fibroblasts. Well, we want college, and that will be replaced by collagen. Type one collagen, which is the stronger collagen or like for like collagen will then go on to a batter, healing with less scar tissue and less recurrence of an ulcer in a chronic wound signaling for fiber. Plastic recruitment is not occurring, and collagen is quickly degraded. This college in degradation is triggered by excess matrix material pro Dionysus or better known as M M. P s. If there is an abundance of collagen, this will help minimize the unfavorable effect of the M. M. P s. Now it's important to know that delivery of collagen and addressing can act as a sacrificial substrate for excess stem and peace. So oxidized, regenerated cellulose or O. R. C is, we've discussed what is cellulose. It's a major component of all plants, once oxidized, or C is completely bio resolvable and readily degrades through fluid absorption and subsequent jelling. In the studies that have been shown in vitro, it's been shown that O R. C number one, the grades to glucose and glue chronic acid, which will lower the pH of the wound. Now it's been shown in the research studies that lowering the pH will help to control bacterial levels. In addition, bacterial static properties. Next, the RC will show stimulated cell migration and growth. It will reduce, as we've discussed earlier, Proteus activity levels, specifically the last taste Proteus and last scavenge free radicals and bound excess metallic ions. So what is our ideal dressing? And what are the benefits of silver without harming cell growth? The ability of O. R C college and containing silver will reduce bile burden and retained dermal cell viability. What do we mean by that? Well, silver concentration is important, but, uh, utilizing too much silver can actually be toxic to the cells. If we use to little amount of silver, we're not gonna have any microbial effect at all. So it's important just to optimize that amount of silver so that we can increase cell growth, re genesis and having an anti microbial effect, but without being toxic to the cells. So the initial bacterial levels that tend to the fifth of greater with the use of silver such as MRSA, E. Coli strep biology knees V. R E and Pseudomonas organ osa. So a pivotal RCTI study with the use of collagen or see with silver o. R C in diabetic foot ulcer patients showed number one at the 14 week RCT prom, a gram prisoner matrix versus a control of a basic wet to dry standard of care. Comparing 25 versus 15 in the control study showed significantly mawr diabetic foot ulcers achieved a greater than 50% reduction in one area versus the control at Week four, and we're looking at about a difference of about 79% versus 43% with a significant P value off 430.35 At Week 14. The number of wounds completely healed was 52% with the O. R. C versus 31% respectively. Now, if we look at the graft, we'll see the percent of healing as we discussed, 79% utilizing the program prism of Matrix versus 43% utilizing the control study. So we look at this pivotal RCTI with collagen, or C, silver and RSC and diabetic foot ulcer patients. The results for infection what it showed was that there was a significant lower percentage of wounds withdrawn due to infection. In many of these studies, we have to see patients unfortunately withdraw from the study due to infection. Well, if you look here, you'll see that in the college. In our city silver RC study no patients were withdrawn due thio infection, whereas in the control study, 33% had to be withdrawn from the study due to infection. So we have some interesting cases to display today. Number one this case, uh, diabetic foot ulcer study utilizing prom a gram Prisma matrix. A 74 year old male with a diabetic foot ulcer of seven months duration Previously one that went a transmitter. Sally amputation, as you obviously see here as a result, oftentimes due to weakness and due to a various deformity after the transfer metatarsal amputation, a ulceration occurred and it weeks zero. This ulceration was treated with the pram a gram prisma matrix. At Week four, you can see that there's been some consolidation with re epithelial ization of the wound and a week 13 complete resolution of the ulceration. A second study of a 68 year old diabetic insulin dependent male with stages 2 to 3 ulceration secondary to diabetic peripheral neuropathy and excessive pronation of his foot. Hama Graham Prisma Matrix was initiated a week zero for this ulceration due to the pivoting of the Alex and due to the neuropathy and due to the compensation and 4 ft various and planet flexing of the fifth metatarsal, we are utilizing the program Prisma Matrix and then a Week four. Seeing that ulceration improved significantly and obviously a week eight, the alteration improved with type of characteristic tissue development. Unfortunately again, due to the pronation of this patient developing blister formation list of formation was resolved in the ulceration was decreased by more than 50% at week eight. Week 12 You can see that the hyper Cara ta tick tissue buildup continues, but the ulceration now has decreased to probably about 75% at week 12. In a third case, a 62 year old diabetic male with a Stage three, he'll ulcer host agreement and utilizing the program Prism of Matrix, initiated at Week zero. You can see the level of the ulcer and the use of the program, Prisma and improvement of the ulceration, a week. Four to about 50% decrease, both in depth and in size of the ulceration. A 72 year old diabetic Orel controlled with a stage to ulcer the medial Alex again with hyper characteristic tissue secondary to obesity. Excessive pronation. Gay problems with the application of the Palm A gram Prisma in the first week zero and then a four weeks developing good granule ation tissue decrease in consolidation of the ulceration. 1/5 case. A 77 year old diabetic, insulin controlled male with diabetic peripheral neuropathy. Peripheral arterial disease. Post debris Men. Reception of osteomyelitis with wounded essence, as you see here at week zero with application of the Palm a gram, prism of matrix and then it Week zero. The application of the Matrix Gannett Week zero on the control lateral side and a Week four Utilizing the Matrix again with decreased size of the wound and the ulceration, both in size and in depth. Very interesting case of a 77 year old female diabetic with coronary artery disease, hypertension, arthritis, chronic kidney disease for for material disease with chronic osteomyelitis and a strong history of critical lower limb ischemia status. Post right pop little plantar arch bypass and a post transmitter Arsal amputation of her left foot. Unfortunately, she developed some breakdown both immediately and laterally. So it weeks zero, we apply the pomegranate Prisma matrix, and this is a very vory a stoop case of good healing. So, as you see here, at four weeks, the ulceration decreased significantly good grain relation bed much more superficial and consolidating and size and to our amazement and to our hearts content we see it. Week eight complete resolution of the ulceration now case Study number seven a 68 year old diabetic male was staged 2 to 3 ulceration. Very common. Disallow ulceration secondary to a hammer toe condition with contracted extensive tendon and flexor tendon with the use of the pentagram Prisma both in week zero just that week to where we were able to achieve regulation, tissue development, fiber, plastic activity, college and synthesis. And the wound decreased both in size and depth Significantly. Now, why is this important? Because the pomegranate prisma afforded a good wound healing basis and promoted the healing so that this one would not deep increase in both sides and depth. As we know, due to this condition. Quite often these wounds will actually deepen to the and exposed the distal phalanx bone, which would then could go on toe CIA myelitis and possibly amputation. So if I utilize in the program prison in this case, we're able to achieve, uh, decreased wound size and depth and achieve good resolution to this wound. It's a very interesting case. Study. 36 year old diabetic male insulin controlled on poorly controlled If that post surgical debridement reception of ASEAN, my Olynyk bone of the Alex into Fallon's Jill Joint and an application of the, uh, dermal matrix that we utilized initially, once the matrix was removed. Then we initiated care with the palm, a gram Prisma matrix and, as you see here a week four and you'll see in the time lapse how much improvement we saw at Week six. Look how much better this looks, how much more superficial and we just have this small, all sort of area left at week 12. But five months complete resolution of that wound, and that was a tough one within osteomyelitis and a very deep wound. So we're very pleased with the achievement and with the use of the prom a gram Prisma in that particular case. So in summary, the collagen or C publications have shown that reduction in the Proteas activity in vitro will clinically effect be effective in helping to heal stalled wounds. There's been extensive publications support at all levels in vitro and in vivo in clinical patients who have had significant diabetic ulcers. Stalled wounds with the use of the mammogram Prisma matrix The college NRC provides an optimal environment which promotes wound healing. And the clinical studies, as we've shown, have demonstrated improved clinical outcomes. So the importance that four weeks have shown that the diabetic foot ulcer area at Week four can be a key predictor of complete healing at Week 12, as we described in the very beginning of the lecture, this has been shown in perspective. Multi center trials conducted in about 11 US sites with about 276 patients enrolled 138 patients who need treatment arm. So what's the significance that we see with this study Number one that patients with an ulcer area have shown reduction greater than the median of 53% a week four and 58% healing at Week 12 and patients with an ulcer area reduction of less than the meeting than 53% a week. Four A 9% healing at week 12. The healers, about 82% show a change in wounded area. Week four. Where is the non healers? 25% change in wound area at week four. So let's look at another subject. Let's look at negative pressure wound therapy and time negative pressure, which we all are very familiar with. And we know how successful it has been for our wounds and for our wound care treatment. When this is applied to a wound via a sealed foam or God's dressing, this will help to facilitate wound drainage. Reduce Idema and the infectious materials that air in the wound. Negative pressure will in therapy. Following debridement has demonstrated to support the time principles as it facilitates the removal of exit date and infectious material. So when we look at a side by side, look at mechanically versus Elektronik Lee powered negative pressure wound therapy. We're very familiar with the Elektronik Lee powered negative wound therapy. Let's look at the mechanically powered snap therapy system with the use of a cartridge. As you see here, a snap system has an advanced dressing kit. It also has a blue foam dressing. It has a bridge dressing kit as well, when we look at our four phases of wound healing, when we look at the first phase or him a static phase one. When we look at the inflammatory Phase two. When we look at the proliferated WCI Phase three, where there's epithelial ization and granule ation formation development and last where we see in the maturation phase for So when we look at the snap therapy system with its advanced dressing kit and the advanced dressing kit and the bridge, we see that the snap system can be utilized for ah, variety of phases of wound healing, whether it be from the initial phase, whether it be from the inflammatory phase, the proliferator phase and then even to the extent of the maturation phase. So were the sites that we can utilize the snap therapy system when there are a number of sites of the body that we can utilize the snap therapy systems such as the flaps and graphs that air utilized in plastic surgery, chronic wounds, such a Zen Thera. Sick surgery, acute wounds, traumatic wounds, pressure to Cuban I ulcers in the cycle area. The hiss wounds sub acute wounds, surgically closed incisions, a zwelling, the venous Stasis, ulcers, rations and the diabetic foot ulcers, as you see here, an amputation of the second toe with a wound. Deficits that is perfect for a snap therapy system to try to close this wound and achieve Stage three and stage four of the wound healing process. So here's a case study of ours. A male 51 year old diabetic, insulin controlled with chronic kidney disease on renal dialysis with peripheral arterial disease, diabetic peripheral neuropathy who were developed necrotizing fasciitis of the entire planter aspect of his foot and the 4 ft lateral aspect of the foot. He went on to a partial 4th and 5th Ray imputation and at that point be where he developed, uh, breakdown off that wound. A application of Venice Cellular dermal matrix skin substitute was utilized, followed by the use of a split thickness skin graft, then followed by the use of a Prisma mammogram matrix at week's zero where we utilized the pomegranate prism of matrix. So what Week 32 we discontinued the use of the pomegranate Prisma application. So, as you can see after discontinuation of the mammogram Prisma Matrix at week 32 we then initiated utilizing the snap therapy system. Overlying the ulceration wound on the planter aspect of the left heel in an arch, as you can see the tubing evacuating the fluid from the wound with the cartridge, Thank you for your kind attention. I hope that I was able to demonstrate the benefits of our mammogram Prisma matrix as well as the snap negative pressure womb therapy system to you today and show you the benefits and how it can enhance our wound healing, particularly in the diabetic foot alterations.