Wound care is a growing public health burden with new clinical products emerging seemingly daily. But how to know which products are useful for which patients and how to access such information can be a challenge for busy clinicians. lerEXPO recently hosted a wound care technology expert panel sponsored by vTail. The panel included Matthew Regulski, DPM, FFPM RCPS (Glasg), Director, Wound Care Institute; Thomas E. Serena, MD, FACS FACHM, MAPWCA, founder and Director of The Serena Group; and Lee Rogers, DPM, FFPM RCPS (Glasg), President, American Board of Podiatric Medicine. The session was moderated by LER Founder and CEO, Rich Dubin. The following is an edited version of the transcript from that session.
LER: What is the most effective way to learn about new technologies and products in the wound care space? What are your go-to resources for getting information?
Dr. Serena: It’s more and more difficult because you don’t have reps coming into the hospital. We use an app [smart phone application] now. There are many advantages to these platforms that allow us to communicate with sales reps. I like them primarily because they work on my time, I can download material and get information in an unobtrusive way. So, I like that I am in control of how that works. Our group of nearly 40 Wound Care centers has downloaded the app from vTail—it’s incorporated in our practice. Another source is virtual conferences; that’s about all we have right now, but things won’t be the same post-pandemic. It’s going to be a different world.
Dr. Regulski: I think vTail is going to be a tremendous way for us to be in contact with physicians and with the industry.
Dr. Rogers: I engage a lot with the reps. I want to know what’s coming out and what’s new; however, I like their conversations with me to be short and to the point. If you wait to learn about new technology when you go to continuing medical education meetings or if you wait for it to come out in a journal, you’re a little too late.
LER: Do you think that wound care, in and of itself, will become a medical specialty?
Dr. Regulski: It’s becoming so highly specialized. There are talks about having specific residencies in wound healing, limb salvage, diabetic wound healing, all different types of specialties. It’s becoming so complicated with the regenerative medicine platform and in the science of healing. Considering a diabetic foot ulcer has a 47% mortality rate, venous leg ulcers have a 29% all-cause mortality rate, and the country is spending about a million dollars every 30 minutes on diabetic foot ulcers (DFUs) and complications—I think it definitely is, without a doubt, a specialty.
Dr. Serena: I would say foot and ankle surgeons are ahead of the medical doctors in regard to wound care. [Foot and ankle specialties] have a lot more fellowships than we do and we’re trying to catch up. There are a number of fellowships now that are available and, hopefully, there will be a lot more and we’ll be able to get a variety of different specialties such as in DFUs and in general wound care.
LER: Is there a recommended wound care certificate or program that either of you might recommend?
Dr. Regulski: There are different societies that put forth recommendations: the Academy of Physicians in Wound Healing, American Professional Wound Care Association, and American Board of Wound Management. I, as a podiatrist, have 2 certifications from the American Board of Multiple Specialties in Podiatry, in both diabetic wound healing and limb salvage. It was an excellent test, very telling of your knowledge, and very difficult. If you are specializing in wound care, I think it’s important to become certified, so it tests your capabilities.
Dr. Serena: We’re primarily using the American Board of Wound Healing and that may be because I was past president of AAWC (Association for the Advancement of Wound Care), and that’s who they use. However, there are a number of available programs that are really quite good.
LER: What country or nation do you feel is at the forefront of wound care technology advancement?
Dr. Serena: I think the United States. Everybody wants to sell here; we’re 50% of the world marketplace. I get a call a week from somebody who has a product somewhere in the world who wants to bring it into the U.S. and wants clinical trials and those sorts of things. So, I think we can say we are at the forefront of wound care technology. The Italians do a fabulous job in DFU management, as evidenced by Italy’s fall in their major amputation rates throughout the 21st century. A lot of the Western countries are on par, but the place that industry wants to be is here.
Dr. Regulski: I’m working with a Polish company and a Swiss company on some good stuff but, like Dr. Serena said, everybody wants to be here as well.
LER: What is your favorite piece of technology and how do you incorporate it into your daily practice?
Dr. Regulski: There are a lot of good things for biofilm management and for the detection of wound healing. The Polish company I mentioned previously—we’re doing flow-mediated skin fluorescence, looking at NAD+ (nicotinamide adenine dinucleotide) fluorescence in the epidermis to signify wound healing cascade after post-obstructive reactive hyperemia. The remote ischemic preconditioning that we just finished a clinical trial on had an 83% healing rate compared with standard of care. That was a fascinating thing, looking at the generation of anti-inflammatory proteins within the body and angiogenic signaling to stimulate wound healing just from a pump on the patient’s arm.
There are all kinds of good things out there—exosomes, Wharton’s jelly injections. But you have to practice good standard of care medicine—offloading devices, total contact casting is crucial, multi-layer compression in venous leg ulcers—to get you to the point that you can put a regenerative matrix, or a skin sub or skin graft on the wound.
Dr. Serena: I agree 100%. It’s always basic wound care before you use the nice shiny new tool. Of course, we all love the shiny new things. We’ve done a lot of work with MolecuLight and visualizing bacteria that’s turned out to be much better than I thought it was ever going to be. It has a very high positive predictive value. We’re doing some research now with the oxy deoxy, the snapshot device, and that may show some promise particularly as it relates to hyperbaric oxygen. We’re really focused on diagnostics—the fluorescent imaging, the oxy deoxy, some of the biomarkers that are working their way through the US Food and Drug Administration (FDA)—what’s got me most excited are the diagnostics, but there’s a lot of great stuff coming along in the pipeline.
LER: We talk about a lot of positive impacts that technology can make in healthcare. Are there any negatives that you have experienced, what might they be, and how can you mitigate them?
Dr. Regulski: The hardest part for me is patient compliance—a lot of people who smoke, a lot of people with uncontrolled sugar. You educate them, and you refer them to multiple specialties to help them, especially the diabetic population. However, they don’t want to go to a dietitian, they don’t think they can help them, or they’ve been there before. They don’t want to give up smoking. I think the patient compliance aspect plays in this.
Dr. Serena: I think one of the problems that I see with technology is that we have a lot of pathways through the FDA, and even now with CMS (Centers for Medicare and Medicaid Services), but the products don’t have good evidence. It may just be a ‘me-too,’ but that doesn’t mean it works the same. I like to use products that have done at least a single clinical trial, that have shown some benefit against some reasonable standard of care. I think the price of getting into the marketplace should be that you have to do a trial, because half the trials you do, you learn something you never planned on and had nothing to do with the product.
Dr. Regulski: Right. And like Tom says, in the skin substitute market, 120 skin substitutes are on the market. How many of them actually have RCTs [randomized controlled trials] to show they actually heal in 12 weeks? Not many at all.
LER: Do you ever use technology for custom diabetic shoes, primarily for patients with Charcot deformities? And if so, is there an app or program that works better than another?
Dr. Regulski: We have 3 orthotists who work in our practice, and they do a lot of molding to catch all those nuances of the Charcot foot. It may be kind of old school, yet they make some really avant-garde stuff. As far as using an app or program, they use a computer simulation that can take an image of the foot, but a lot of times they will still mold with plaster and catch those nuances.
LER: Medicare does not cover custom orthotics for diabetic patients unless they have complications already. Would it not be better to prevent the injury and ulcers by providing custom orthotics?
Dr. Rogers: When you’re talking about a partial foot amputation, you’re dealing with a prosthetic or shoe fill, and I don’t have a problem getting those covered. I do have an issue getting reimbursement on the preventative side, which is too bad. On the preventative side, if you want to know what’s really going to be taking off and be interesting is remote patient monitoring. That’s going to be the future for diabetic foot prevention. Remote patient monitoring is kind of like a fire alarm for the foot. Let’s say we’re dealing with temperature–that’s one form of remote patient monitoring that we can do for the foot. You get a hot spot–which studies have shown can predict an ulcer up to 35 days in advance. We have to respond to that hot spot and intervene in that case, and that may be with modified footwear, evaluating the biomechanics, looking at the vascular supply to the foot, and a host of other things. I think that’s the future of prevention.
LER: And what type of technology would you suggest that they look at with respect to that?
Dr. Rogers: There are 2 companies that are doing a really good job right now, Orpyx and Podimetrics. Other companies are coming in as well. One of the issues is that the device itself can be cost-prohibitive. The [Veterans’ Administration] actually has patients getting these devices and going home.
The technology was present, and there was even reimbursement, before the pandemic, but it’s being propelled by the pandemic to make this more practical to do now. I think you’ll see some less expensive devices being developed.
LER: Should effective shoe-based approaches, and receiving reimbursement for such, be a focus for prevention?
Dr. Rogers: I think we can all agree: improper footwear causes ulcers. However, studies in which patients are provided with proper footwear have, unfortunately, led to some mixed results where there hasn’t been as strong of data that we would have expected to support that. That’s given ammunition to payers to deny these types of services. I think it should be a major topic of focus. I know the APMA (American Podiatric Medical Association) is always focused on this with, again, mixed results.
What I want everybody to understand is that in order for a patient to develop an ulcer or trauma, it’s a result of pressure times repetitive cycles of stress. I think we’re going to see prescribing activity like we prescribe a drug come more into our thought process. And when these hot spots are occurring in remote patient monitoring, the first and most important thing is to stop walking. “Mr. Jones, we have a hot spot predicted to ulcerate. Until get into the clinic, you’re limited to X number of steps per day.” Offloading and the transfer of pressure is also important to consider.
Dr. Regulski: I wonder if there’s something we can do to help with that tissue to offload in these high-pressure areas. I have used Leneva on about 150 people to prevent these areas that occur, then callous, and then that could then lead to an ulcer. I think that’s helped significantly for my patients.
LER: A home healthcare nurse sometimes will show up in a patient’s home and find dressings and treatment modalities they’re unfamiliar with. Aside from Google, what would you recommend as a resource?
Dr. Regulski: Our visiting nurses spend some time with us in our wound centers so they can learn how to apply dressings and to recognize different types of modalities that we use. That’s helped a lot. It has also increased referrals.
Dr. Rogers: There’s a group that I’ve been working with called Innovative Outcomes, which supplies patients with single-dose packages of dressings. There’s a QR code on the box that you can scan, and it plays a video of exactly what’s in that package and how to put it on. They provide education in a technologically friendly way.
Dr. Serena: I suggest using apps such as this sponsor where the nurse can get ahold of practitioners. One of the features that I think is coming is peer-to-peer communication, so if there is a problem, the nurse can send a message with a picture, and the prescribing doctor can respond.
LER: Well, I think that also leads us into a great question here. Has the pivot toward more use of technology harmed or helped the doctor-patient relationship?
Dr. Serena: It’s led us to some interesting challenges. Because our patients are texting us, it has led to increased familiarity. You’re not in the clinic with that white coat on, telling them what they should do. Now, you’re communicating with them freely. I think a peer-to-peer type program is going to be a good thing because you can put guardrails on that kind of communication.
Dr. Regulski: I think it’s helped a lot. I give trusted patients my cell phone in case I have to put them in the hospital. These people have a lot of questions after they leave, and they forget things and get frustrated. I think the telemedicine field, and now with this peer-to-peer vTail, it’s comforting to patients because they have a lot of questions. I think it helps cement the relationship.
Dr. Rogers: I think all the new communication aspects really enhance the physician-patient relationship. But there are other parts of technology that I think have harmed the physician-patient relationship–point-and-click electronic health records where you are staring at the screen the whole time, filling in the information because you need to get through all of that. You might argue that it creates more standardization and all the benefits that come along with that, but it leads to a less personalized visit.
LER: Do you see fewer patients coming into clinics because they can get your advice over the phone or through telemedicine less expensively?
Dr. Regulski: We’re busier than ever. Due to the virus, a lot of people have been afraid to come to the office, the wound center, or even the hospital. Now, unfortunately, they are going to be in the hospital even longer—needing multiple debridement surgeries and things of that nature. The amputation rate is up elevenfold in diabetics. We never stopped seeing patients during the pandemic, because if you stopped seeing the patient in office then you’re going to see them in the hospital.
Dr. Rogers: Some wound centers in our area closed down during the height of the pandemic. But wound care is not non-essential; it’s, in fact, the opposite.
LER: Is there a great resource for understanding the business side of wound care? For example, the hospital administration is hesitant to invest in the advancements unless there’s a business plan that shows return on investment and implementation, but the presenting doctor doesn’t have that type of business background.
Dr. Rogers: Hospitals engage management companies because they don’t understand everything to the business side of wound care; it is very complex. I have always advocated that the wound care doctor should have a seat at the table when interviewing these management companies to determine how the management company will work with you to get what you and the hospital both need, because that’s how the patients get better.
Dr. Serena: You better bring data. For example, we find one center that is willing to implement the technology we suggest, we collect all their reimbursement data, and then we present that data to other hospital purchasing departments. If you can show them that this other hospital is using this device, it’s getting paid, and show the return on investment, it gives them a level of comfort.
LER: We’re coming up to a close, but I thought this would be a good question to end with. What does the future of wound care look like and what do you think will become obsolete?
Dr. Rogers: The pandemic has changed healthcare forever in some good ways. A lot of these technologies existed before the pandemic, but they became more practical to use—for instance, AI (artificial intelligence) that interprets skin temperatures and provides alerts that are based on predictive measures. I think, in the future, there’s going to be some AI that’s specific to wounds, such as devices that will be able to detect odors and different colors. As for what will become obsolete, in my mind, some of the products that are based on older technology, even some older CTPs (cellular and/or tissue-based products) might go away. People are going to want to see technology based on evidence.
Dr. Regulski: As Dr. Serena said before, I think it’s the diagnostics. How do we know when these wounds are out of an inflammatory state and receptive to put a tissue on, to do a skin graft, to turn a flap, to move more into that proliferative phase? I like the diagnostics to predict healing, such as the flow-mediated skin fluorescence. Or can we determine if the wound will heal on its own by looking at the microvascular functions? I think diagnostics, and very advanced regenerative medicine, are going to help us propel these wounds along a more prolific paradigm and get them healed quicker and be cost-effective.
Dr. Serena: Diagnostics are the future. I also think private wound care partnerships between multidisciplinary groups that are not associated with hospitals will be one of the fastest growing segments in the field.
This program was sponsored by an unrestricted educational grant from vTail. This discussion can be heard in full at lerEXPO.com along with the rest of the 3-hour program; CMEs are available through September 2022.