In 1787, Catherine II (also known as Catherine the Great), a Russian Tsarina, set out on a tour of Crimea, an area Russia had annexed from the Ottoman Empire. The area had been devastated by the Crimean War and was a mess. Grigory Potemkin, governor of the Crimea, wanted to make a good impression, so he built phony portable villages along the Dnieper River and had his men dress up as “happy peasants.” The buildings were just facades, but appeared real enough from Catherine’s barge. As soon as she was out of sight, the structures were disassembled and reassembled farther along her route to be viewed again. Since then, a “Potemkin village” has referred to something that appears real but isn’t, or something built intentionally to deceive. The current paradigm of wound care research is a “Potemkin village” that could destroy the clinical field of wound care.
I don’t know if this façade was created by the U.S. Food & Drug Administration (FDA) or if the FDA just bought into the false narrative. In any case, three general models are recognized for wound healing research: venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers. However, as anyone who works in the field can attest, whether a wound develops and/or persists is multifactorial. By the time that a prospective trial has excluded all the important variables, the study isn’t clinically relevant. We’ve studied this a lot using data from the U.S. Wound Registry (USWR). Randomized controlled trials (RCTs) in wound healing exclude subjects with serious comorbid diseases. We compared the characteristics of DFUs and VLUs treated at the same six wound centers performing five prospective trials of cellular and/or tissue-based products (CTPs).1 The “real-world” VLUs were five times larger than those enrolled in the RCTs and had comorbid conditions excluded in the RCTs. Real-world DFUs were most commonly Wagner Grade III ulcers, whereas those enrolled in RCTs were Grade I. Furthermore, when we compared the Wound Healing Index (the mathematical model that predicts whether a wound is likely to heal) of the DFUs and VLUs enrolled in all CTP trials, we could predict the majority of those ulcers were going to heal anyway, whereas the real-world ulcers receiving CTPs have an index that, on average, predicts they would fail to heal without them. But the fact that we perform non-generalizable trials and then use those results to guide clinical decision-making under the guise of “evidence” is not what really worries me. What worries me is that we are not studying the correct wounds. One study analyzing the 5% Medicare dataset showed the majority of chronic wounds among Medicare beneficiaries are not DFUs, VLUs, or pressure ulcers.2 The majority of chronic wound care problems in this country (at least among Medicare patients) are surgical wounds that dehisce, traumatic wounds that never heal, and chronic ulcers that are related to underlying comorbid diseases. These are chronic ulcers and traumatic wounds in patients who don’t “have the courtesy” to have diabetes, or classic stasis ulcers, or a story or presentation consistent with pressure. They are nonhealing chronic ulcers and traumatic wounds that never close due to the underlying medical problems of the patients that we can’t even pretend fall into one of the aforementioned categories. The contribution of specific individual factors may not seem high (eg, scleroderma), but when they are all combined these “wounds with no name” represent one-third of all the problems we see in wound centers.
In other words, the most common chronic wound/ulcer among Medicare patients is “the wound with no name.” We do not conduct any clinical trials on the most common wounds in the U.S. There are virtually no products targeting them, the conditions that cause them are excluded from every prospective clinical trial, and the outcome data from these patients are not reported by most wound centers because the patients are considered “too complicated,” and thus classified as “under palliative care.” These “wounds with no name” are the biggest part of the wound care iceberg that lies hidden under the surface while we point to DFUs and VLUs. This complicated, messy bucket represents the largest portion of Medicare spending on wounds. They are the most common wounds seen in outpatient wound centers. They are how we spend our tax dollars. The average patient lives with multiple wounds and will spend almost eight months (with weekly to bimonthly) visiting an outpatient wound center. They will develop an average of 1.5 additional wounds during the time we care for them. It gets even scarier, however. I’ve been looking at USWR data on these “wounds with no name” to better understand what underlying conditions the patients are most likely to have. This list may not terrify you, but it should terrify the Centers for Medicare & Medicaid Services: chronic kidney disease, stroke, COPD, chronic heart failure, atrial fibrillation, and depression. Combine any three of those and you have one of the Medicare “trifectas” that result in a seven-fold increase in spending over the average Medicare beneficiary. Patients with any three of these conditions have an average Medicare spending per beneficiary in excess of $60,000. I bet at least part of the reason is that they have chronic wounds and Medicare hasn’t figured that out.
The FDA (through its requirements), the manufacturers in response to the FDA, and clinicians (through their marketing) have created the false picture that a 95% healing rate is achievable in the real world.3 That is only true if you exclude the majority of the Medicare beneficiaries with wounds. We’ve created an imaginary “Potemkin village” of happy wounds that heal. The majority of patients in wound centers have “nameless” wounds that are probably caused by a major comorbid disease. These patients have a high prevalence of the diseases Medicare fears most in terms of cost. Nearly every RCT that has ever been performed in wound care has excluded these diseases – for a reason. If these patients are going to have access to wound care services in the future, it will have to be part of a chronic care reimbursement model, not in an episode-based model. In fact, I think the wound center needs a “wound team coordinator” just like they do in transplant clinics. But, currently, we are headed down the episode-of-care pathway, pretending it is actually going to work. For most patients, it will not. n
Caroline E. Fife is chief medical officer at Intellicure Inc., The Woodlands, TX; executive director of the USWR; and medical director of the CHI St. Luke’s Wound Care Clinic - The Woodlands.
1. Serena TE, Fife CE, Eckert KA, Yaakov RA, Carter MJ. A new approach to clinical research: integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system. Wound Repair Regen. 2017;25(3):354-65.
2. Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and medicare policy implications of chronic nonhealing wounds. Value Health. 2018;21(1):27-32.
3. Fife CE. How should outpatient wound clinics honestly measure success? TWC. 2018;12(4):15-8.