Encore Insights, Ep. 2: The State of Wound Care Research with Dr. Thomas Serena

Like most people in wound care, I never really went into it — it dragged me in kicking and screaming. I was a general and vascular surgeon for years, and wound care just gradually filled up my practice. But what really drove me deeper into the field was the research. There isn't a lot of it in the wound care space, and when we started doing clinical trials and looking at outcomes, it was a genuinely exciting opportunity to start figuring out what's actually going on. That's what kept me here — probably the research more than anything else.

On the physician side, we've been pushing — not very successfully — for wound care certification through the National Board of Medical Specialties. That's going to take years. But the bigger opportunity is on the APP side, because wound care is largely run by advanced practice providers. APPs really run wound care. As we increase the educational opportunities for them — conferences, podcasts, anything that spreads the research — the field will advance. And what Encore is doing now, participating in clinical trials, is really the best education you can get. If you want to truly learn wound care, do a trial.

If you're looking for evidence-based standard of care for pressure ulcers, keep looking — because you're not going to find much. In mobile wound care, the randomized controlled trials for treatment number maybe five. Compare that to cardiology, where there would be five million. We are just getting started. Pressure ulcers have been the redheaded stepchild of wound care for a long, long time, even within the wound care world. There was a large Australian study published earlier this year — a thousand patients — that challenged whether silicone foam dressings prevent pressure ulcers at all, after billions of dollars spent on them. Does that mean they don't work? Not necessarily. It means we have to keep studying, and maybe the setting matters. A product that underperforms in the ICU might perform very differently in a nursing home or a home care setting.

Most of what we have in pressure ulcer management is noise. For diabetic foot ulcers and venous leg ulcers, we've got a solid body of clinical trials to lean on. But for pressure ulcers, it's thin. The basics — debridement, moist wound healing, bacterial burden control, nutrition, offloading — those are well-supported, and no one will argue with them. But then what? Because for a lot of patients, those basics alone don't move the needle. Do you go to a skin substitute? Negative pressure? There isn't a lot of evidence to guide that decision. That's exactly why I'm glad Encore is working with us to gather some of this evidence — we just finished a first series looking at skin substitutes, and we're getting ready to start a second. That's how we'll know.

Facilities are short-sighted on this. They run on very thin margins and don't like adding services. But it costs far less to prevent a wound than to treat one — especially in the litigious environment we're in now, where any wound is ripe for a lawsuit. Plaintiff's attorneys have won some very large awards in this space, and now everyone's looking. The argument we take into these facilities is: put your preventative measures in place, document them thoroughly, and that's your defense. You can win these cases. But without a well-documented prevention program, you're a target. Not all wounds in nursing facilities are related to nursing care — many arterial wounds aren't — but if you can show the court what you did to prevent it, you're in a very different position.

Absolutely, because prevention trials are coming — coming to a nursing home near you. The Australian publication I mentioned is going to light a fire, because many dressing companies make about half their revenue on preventative dressings. Now that the evidence is being challenged, nursing home operators are going to ask hard questions about what's actually working. There's also a compelling legal advantage to being in a trial: because the consent forms are extensive and the documentation standards are so rigorous, there are very few legal actions against nursing homes that are in active trials. In fact, I've never seen one. Plaintiff's attorneys take low-hanging fruit — they don't want to fight something that's going to be difficult to try. And we're also excited about getting better diagnostics into these prevention trials. Shear wave ultrasound, for example, can detect deep tissue injury two days before it's visible — AI can read the images even when a trained clinician can't. Imagine scanning every patient on admission. If they come in with a DTI, it's exculpatory. The lawsuit goes away.

You try to maximize the patient's medical status — which in a nursing home is, okay, fine, they're all sick. And then if you're doing good debridement, the moisture's controlled, there's no bacterial burden, you've got them on protein supplements, and the wound still isn't responding at all — at that point, you need to step back and ask whether something else is going on. Typically if a wound isn't healing in about four weeks, you really need to redo everything. For a lower extremity wound: do they have adequate vasculature? Is it pyoderma? A vasculitis? Prior radiation? Are they on a biologic that's destroying their ability to heal? You need to look at everything and reassess: I'm doing all the right things — why isn't this wound responding?

You're the wound experts. Call it whatever you believe it is. I'm not afraid to call anything by what I think it is — if I think it's arterial, I call it arterial. If uncontrolled diabetes is the primary driver, that becomes part of the clinical documentation, and I let them challenge me. 'You didn't call it a pressure ulcer.' My answer: it's not a pressure ulcer. You need to have good supporting evidence — you can't randomly classify every wound as something else — but if the evidence supports it, you're allowed to say so. You're the experts. There's no reason to be shy about it.

This is a big one. About 1% of nursing home patients have critical limb-threatening ischemia, and over 20% have significant peripheral arterial disease — most of it unreconstructable. You can't fix it. So they get a heel ulcer and then what? The biggest mistake I see is an inexperienced provider going in to debride it. If you debride an ischemic heel ulcer, the patient will almost always end up with an amputation. When you debride a wound, you triple the metabolic demand for the skin in that area — and it already can't meet that demand. So it's going to get worse. The other issue is documentation. A diabetic patient with a heel ulcer and peripheral arterial disease has a neuroischemic ulcer. That's the etiology. Yes, it's on the heel, and maybe it was triggered by friction on the sheets — but it's a neuroischemic ulcer. If the patient had good circulation, it wouldn't have happened. Document accordingly. The other clinical trap I see constantly: providers feel a pulse in the dorsalis pedis and assume the foot has adequate circulation. At their age and with all their comorbidities, most nursing home patients don't have collateral between the dorsalis pedis and the posterior tibial. You need the posterior tibial open, and you need an ankle-brachial index from the posterior tibial to know whether that heel ulcer is going to heal. This is something called angiosome-directed flow — the heel ulcer is supplied by the posterior tibial artery, and if that's not open, you may see ischemic ulcers even when the foot looks okay.

Right now it's kind of a mess. Trying to do an ABI in a nursing home bed — the accuracy can be quite low. You send the patient out for a vascular study, the nursing home doesn't want to do it, and even if they agree, you're waiting three or four weeks. And duplex isn't a good bedside screening tool. We're actively working to fix this. There's a Doppler device in testing now — no cuff required — that transmits over Bluetooth to a laptop and can be read remotely. It's based on mean arterial pressure rather than waveform interpretation, and early studies show better accuracy than traditional bedside methods. We're also looking at near-infrared spectroscopy in combination with this Doppler, and early results suggest the combination could give you real confidence in your vascular assessment at the bedside. I think within the next twelve months, that logistics problem will be solved. And it's the mobile providers — the people doing this work in nursing homes every day — who are driving that innovation. That demand didn't exist at scale before. Now it does.

There's actually a really solid data point here. For lower extremity wounds — diabetic or venous — if the wound hasn't healed by 40% in four weeks, it's not going to heal. We've studied this in thousands and thousands of patients. If you haven't hit that 40% mark at four weeks, your probability of healing at 12, 14, or 24 weeks is 9% or less. So if you keep doing what you're doing, it's not going to work. That's your signal. Once you've completed debridement, gotten the bacterial burden down, and confirmed adequate vasculature — if healing still isn't happening at four weeks, that's when you open the advanced wound care toolkit: skin substitutes, negative pressure, topical oxygen. Topical oxygen, by the way, should have DME availability in 2027, knock on wood. There should be an LCD for it in most MACs in 2027, and the evidence in diabetic foot ulcers is strong. So there will be more options in your bag.

MolecuLight is getting a real Medicare reimbursement code in January 2027. That matters enormously — if something doesn't get paid, you might as well not launch it. After three years of working with Medicare, we finally got a code for the device. It detects bacterial levels greater than 10 to the 4th colony-forming units per gram of tissue. That's the threshold at which bacteria — not necessarily infection — will inhibit healing. That's well-documented. So the device helps you identify wounds that look fine on the surface but are carrying a bacterial burden that's silently preventing them from closing. Once you know, the response is often straightforward: debride, apply an antiseptic, and in two or three weeks the biofilm comes down and sometimes the wound just heals like gangbusters. Other times you'll need something more advanced, but at least you know what you're dealing with.

There's a lot of fun stuff. We're getting ready to start an early-phase clinical trial on phage therapy — viruses that kill bacteria. Instead of loading patients up with antibiotics, you put a phage-loaded dressing in the wound and it targets specific organisms, usually Staph and Pseudomonas, and kills them directly. Preliminary phase-two results were interesting. There are also two new debriding agents entering clinical trials — one from MediWound and another called DEBRICHEM from DEBx Medical. DEBRICHEM you apply to the wound, leave it on for 60 seconds, and wipe it off — it debrides like a scalpel blade. It's approved in Italy and available in the Netherlands right now; it'll go through the drug approval route here. And there's cold plasma, which is showing promise for pressure ulcers and diabetic wounds. The common thread for all of these is that I want to see them tested in nursing home populations — because if you're going to sell a product in nursing homes, the trial should be done in nursing homes.

I've always said: if you're going to sell a product into a nursing home, if it's going to be on their formulary, your trial should be done in the nursing home. It's not the same population. Anyone who's rounded in a nursing home knows it's completely different from the outpatient people who walk into a wound clinic. So if you want to know if something works in a nursing home, you need to study it there. The new debriding agents, cold plasma — those trials should be done in nursing facilities. And ten or fifteen years ago, nursing homes would have flatly said no to research participation. That's really changed post-pandemic. Now I find them actually anxious to participate. The mobile providers on the ground have a lot to do with that shift — and that's a big deal for the whole field.

The US is fairly parochial about research — Medicare wants American patients in the data, which makes sense when they're the ones paying. But the FDA does allow international sites. We have seven centers in South Africa that do excellent work, and we're opening in Greece and Cyprus. We've done a good amount in the UK as well. The goals are a few things: access to different patient populations, which strengthens the generalizability of the findings; help with enrollment on larger trials; and lower costs than running everything in the US. The cross-cultural exposure also gives you a window into products and approaches you'd never see otherwise. I only know about ozone therapy because of work we've done in South America and Europe — there's zero evidence base that would get it into the US, but it's used widely there. And the DEBRICHEM from DEBx Medical I mentioned? I used it in Italy, where it's approved. Everyone wants to sell into the US market — we spend about 50% of all wound care dollars globally. International work gives you a preview of what's coming.

Even with the decrease in reimbursement on skin substitutes, I'm very bullish on mobile wound care. The same thing happened to hyperbaric in 2004 — they cut reimbursement dramatically, everyone panicked, and it came back. New products get approved, reimbursement finds its level. The same will happen here. We have MolecuLight getting its code in January, topical oxygen likely available through DME in 2027, new diagnostics in the pipeline. If you're in this space to treat patients in these settings, you're in it for the long haul, and there's going to be a lot more in your toolkit. And what's most exciting to me right now is that we're actually doing clinical trials in nursing facilities — that's really only been possible post-pandemic. That's very new. You're at the cutting edge because you're doing research where the patients are.