I am still recovering from the shock. I opened my October 9th JAMA and there in the Clinical Update section was “Management of Chronic Wounds -2018.” Congratulations and kudos to Drs. Jones, Foster and Longaker! They highlighted the diverse array of treatment options available in a densely information-packed 2 page summary.
I’m worried, however. There’s something that’s deeply troubling me. If we consider for a moment all the clinical trials reviewed in that Clinical Update, with the exception of hyperbaric oxygen therapy studies, the prospective clinical trials don’t reflect the real world. We’ve studied this a lot using registry data.  RCT’s in wound healing exclude subjects with serious co-morbid diseases. We recently compared the characteristics of diabetic foot ulcers (DFU’s) and venous leg ulcers (VLU’s) treated at the same 6 wound centers performing 5 prospective trials of cellular and/or tissue based products (CTP’s).(1)

    • The “real world” VLUs were 5 times larger than the ones enrolled in the RCTs, and real VLU patients had co-morbid conditions excluded in the RCT’s.
    • Real world DFU’s were most commonly Wagner Grade 3, whereas those enrolled in RCT’s were Wagner Grade 1 ulcers.

When we compared the “Wound Healing Index” (the mathematical model that predicts whether a wound is likely to heal) of the DFU’s and VLU’s enrolled in all cellular and/or tissue based product RCT’s, we could predict the majority of those ulcers were going to heal anyway, whereas the real world ulcers receiving CTP’s have a WHI that, on average, predicts they would fail to heal without them.
But the fact 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 aren’t even studying the right wounds. The Value in Health study analyzing the 5% Medicare dataset showed that the majority of chronic wounds among Medicare beneficiaries are not DFU’s, VLU’s or pressure ulcers.(2) The majority of chronic wound care problems in the USA (at least among Medicare patients) are surgical wounds that dehisce, traumatic wounds that never heal, and chronic ulcers that are related to underlying co-morbid diseases. In other words, the most common chronic wound/ulcer among Medicare patients is “the wound with no name. We don’t do any clinical trials on the most common wounds in the USA.  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. The wounds with no name are the biggest part of the wound care iceberg that lies hidden under the surface while we point to DFU’s and VLU’s. This complicated and 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 has multiple wounds, and will spend almost 8 months with weekly to bi-monthly visits to 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. I’ve been looking at US Wound Registry 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 CMS: chronic kidney disease, stroke, COPD, CHF, atrial fibrillation, and depression. Combine any 3 of those and you have one of the Medicare “trifectas” that result in a 7-fold increase in spending over the average Medicare beneficiary. Patients with any three of these conditions have an average Medicare spending per beneficiary (MSPB) 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. That is only true if you exclude the majority of the Medicare beneficiaries with wounds. We’ve created an imaginary little village of happy wounds that heal. And it it’s totally fake. The majority of patients in wound centers have “nameless” wound 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. In fact, I think the wound center needs a Wound Team Coordinator just like Transplant Clinics. But, currently we are headed down the “episode of care” pathway, pretending it is actually going to work. For most patients, it isn’t.

This is a photo taken at 2 PM a few hours before Hurricane Harvey turned the 4th largest city in the USA into an island. There are people still driving south. I understand why. If there’s one thing I’ve learned over the past ten years, it’s that people believe what they want to believe, no matter what data you show them.

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 Apr 17. doi: 10.1111/wrr.12538
Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds Value Health. 21(1): 27-32, 2017.