In 1787, Catherine II (also known as Catherine the Great), a Russian Tsarina, set out on a tour of the 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 originated with the U.S. Food & Drug Administration (FDA) or if the FDA just bought into the false narrative. In any case, three general models were developed for wound healing research: venous leg ulcers (VLU’s), diabetic foot ulcers (DFU’s), and pressure ulcers. However, as anyone who works in the field can attest, wounds are a SYMPTOM of disease, not a disease. By the time that a prospective trial has excluded all the co-morbid conditions that might impact the outcome of the trial, it has excluded all the potential patients who need it.
The real problem is that DFU’s, VLU’s and pressure ulcers are not the wounds we most need to study. Analysis of the 5% Medicare dataset showed the majority of chronic wounds among Medicare beneficiaries are not DFU’s, VLU’s, or pressure ulcers. They are surgical wounds that dehisce, traumatic wounds that never heal, and chronic ulcers “with no name.” All of these exist due to the underlying medical problems of the patient. In other words, the most common chronic wound/ulcer among Medicare patients is “the wound with no name.” 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.”
It gets even scarier. I’ve been looking at U.S. Wound Registry (USWR) data on these “wounds with no name” to better understand what underlying conditions the patients are most likely to have. This list of conditions associated with chronic non-healing wounds 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. Medicare fears these conditions because they are expensive. I bet they are expensive, in part because Medicare has not noticed they have chronic 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 co-morbid 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. Sadly, we are headed down the episode-of-care pathway, pretending it is actually going to work. It’s not going to work.