NIAGARA FALLS – The Wound Center of Niagara has quite a few reliable tools to treat some of the most stubborn wounds that people can have, though only a few have shown the potential of Aurix.
"Right now, it's a trial treatment, not a standard therapy," said Dr. Michal Mitchell, one of seven physicians affiliated with the wound center. "It's a unique trial because it's Medicare-sponsored. It's pretty unusual for Medicare to back a study and pay for it."
The center is at the front end of a phase 3 trial – the last and most promising stage of medical research – in a process that removes a small portion of a patient's own blood, spins it in a centrifuge, separates plasma and growth factors and mixes it into a gel. The gel can then be directly applied two of the most common wounds that centers like the one in the Falls treat: a foot ulcer, venous leg ulcer or pressure sore.
[Those eligible for the trial must be on Medicare. Call the center at 278-4424 for more information.]
The wound center is one of 30 nationwide participating in the Aurix study. The next closest trials are taking place in Ohio and Poughkeepsie.
Mitchell, who grew up on the West Side of Buffalo, is a Canisius College and University at Buffalo medical school grad who started his Williamsville practice in 1996. The general, vascular and endovascular surgeon works four hours each workday at the multidisciplinary wound center, which also is staffed by two podiatrists, an infectious disease doctor, a cardiothoracic surgeon, and a general and vascular surgeon. A primary care physician who specializes in geriatric care will join the practice in June. All work for RestorixHealth, a White Plains-based company that runs 200 wound centers across the country.
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Aaron Wilson is director of the wound center. The Niagara Falls native holds bachelor's degrees in health education from SUNY Brockport State and nursing from Binghamton University. He worked for more than decade in a Cooperstown hospital and in medical sales before helping to start the wound center in 2013 on the seventh floor of the parking garage at Niagara Falls Memorial Medical Center. Last spring, it more than doubled in size, to 5,000 square feet.
Its patients come from across the region and southern Ontario.
Q. When is somebody likely to have trouble with wound healing?
Mitchell: There's a population where we can predict that. It's the diabetic. The diabetic smoker is the most likely to have problems. The diabetic, the smoker, some who is obese - they're at greater risk.
Q. What tends to be your patient population in demographic terms?
Mitchell: The most common thing for any wound center is going to be diabetics with diabetic foot ulcers and venus leg ulcers and osteomyelitis, which is an infection in the bone.
Wilson: Pressure ulcers also is in the top four.
Mitchell: The average age is 40 to 70. It's pretty evenly distributed between men and women. We see younger non-compliant diabetic patients, too. We saw a woman in her 30s recently that has lost a couple of toes. We're trying to get her with an endocrinologist and on the right diabetic control. Education is a huge part of it, whether it's getting the proper footwear or taking their medications. We encourage compliance so you can reduce limb loss. That's a major challenge in terms of the education part.
Wilson: Our population tends to tilt toward the poor and undereducated. I think the biggest thing that helps is our customer service. We want to help them come back. We work on compliance and the proper education, getting them linked up with Health Home, one of our Medicaid programs that helps manage patients more on a social level than medical level. They help with rent, with medication management, transportation to and from appointments.
Q. What is it like for a patient who, for the first time, comes in with a wound that won't heal? What sorts of questions and concerns do they have?
Wilson: Being able to tell on the first visit if there's a blood-flow issue is a big deal in health care and we're able to do that here.
Mitchell: We need to determine what time of wound it is. Just because somebody walks in the door and says they're not diabetic, we can't assume they're not, so we do all the appropriate testing in that regard. We try to differentiate what type of wound it is based on how it looks, the patient's blood flow and the algorithm goes from there. If we determine there's a blood-flow issue, there's certain testing we have to do. A person might need surgery ... to restore their blood flow.
Q. What wounds can a hyperbaric chamber help?
Mitchell: The top two are certain grades of diabetic foot ulcers - it depends on severity - and osteomyelitis. Those comprise probably 80 percent or more of the patients who require hyperbaric oxygen therapy. Other uses include if somebody has had radiation therapy to the head and neck or therapy for radiation from prostate cancer where there's injury to the bladder and rectum. Nationwide, the percentage of wound patients that end up in the chamber is about 10 to 15 percent.
Q. What are some of the other standard treatments do you use?
Wilson: Debridement – cleaning the wound with a scalpel, and removing all of the infection or dead tissue which is an impediment to healing. That puts the wound back into the acute process of healing, reminding the body, "Hey there's a wound here," and kickstarting treatment, hoping this will be the time we can find ways to stimulate the healing process as it cascades through completion.
Mitchell: There are certain stages of healing. There's an inflammatory phase where there's different types of cells that come to the wound and send out signals and markers to recruit different components to your bloodstream to help with healing. If a wound is in a stalled phase and you're not debriding it, it stays in that stalled phase. When you debride it, the hope is that you revert it back to the inflammatory healing and recruit those (helpful) cells. At the end of the day, if you don't have blood flow, or there's infection present, or there's a lot of dead tissue, it's a waste of time. It's no one thing, no magic bullet.
Once we make sure that blood flow is adequate, the tissue is controlled, there's other things we can do. We try to concentrate, particularly with the foot wounds, on off-loading. We help these patients avoid putting pressure on their foot. That might include putting them in a cast. We have different types of footwear, offloading boots. We do some forms of skin grafting here, whether it's artificial, skin substitutes or the patient's own skin.
Wilson: There's negative pressure wound therapy. A vacuum over the top of the wound that helps drain and pull infection out of a wound, and draw blood to that area. I've specialized in that.
Q. What do you think Aurix could potentially mean for your arsenal? How does it differ from standard treatments?
Mitchell: It's an adjunct, in addition to standard treatment. When it does become treatment - and it most likely will - what they emphasized to us during the trial is that if a patient qualifies and get the therapy, they also receive standard treatment, whether it be hyperbaric or a wound vac or debridement. We don't stop what we've already been doing.
We're selecting patients that fall into three different categories for this trail. One, you have to be a Medicare patient. You have to have a diabetic foot ulcer, venous leg ulcer or pressure sores (that elderly with limited movement might get at a nursing home).
Wilson: The big reason Medicare is behind this study is because we use a lot of bioengineered tools. We have bioengineered skin, bioengineered growth factors, all these things that someone makes in a lab, sends to us and we utilize. This Aurix takes all of the things we get bioengineered right from the patient and applies it topically.
First off, you have living cells as opposed to bioengineered cells, the patient's own cells as opposed to cells that were grown in a vacuum. Medicare pays $1,400, $1,500 for these (bioengineered) disks and now potentially can get something in a cheaper way because we're able to get a centrifuge and some vials and, on top of that, we're using the patient's own product.
Q. There already are growth factors on the market?
Mitchell: Some of them available are super expensive. A little vial can cost $400.
Wilson: That's for the patient. You're talking $2,000 total cost.
Mitchell: And it's only available for diabetic foot ulcers. This treatment has wider implications. … One of the difficult things in a wound center is there are so many skin products, so many ointments, so many bandages. You really have to sift through the information and make an educated determination as to what's best. We don't want every single product on the shelf. We've learned here over the last few years to try to focus on the things that have worked for us and not allow every single vendor in. Everything that comes in the door is better than somebody else's stuff. You have to really educate yourself.
Q. If the trial proves effective, will participants be able to continue receiving the Aurix treatments?
Wilson: Absolutely. At that point, it would be released to the general public.
Q. Will it be less expensive than current treatments?
Wilson: At the end of the day it will be because you won't be dealing with lots of R&D costs. The simplicity of this is that it's just a centrifuge and a vial to draw blood. That's pretty much the overhead cost.
Q. Might there be other applications for Aurix?
Mitchell: It's possible. It could perhaps have surgical applications.
Q. Are there any other advances in would care you see coming down the pike in the next few years?
Mitchell: These skin substitutes continue to change and add to our arsenal.
Wilson: We have amniotic fluid products now with stem cells.
Mitchell: We have some on the shelf right now. They can be pretty expensive.
Q. If someone doesn't want a non-healing wound, what can they do to prevent one?
Mitchell: If diabetics got proper foot care after their diagnosis, wound centers probably wouldn't exist. If you're diabetic, make sure you have a podiatrist doing basic things like nail care. Diabetics who have neuropathy - reduced sensation in their feet - or maybe their vision isn't up to par, it's not an uncommon scenario where they come in with a cut on their foot from clipping their nails. That little cut can escalate into a limb-threatening problem. So having a podiatrist and the proper footwear ... is really important. Good nutrition, having good control of their blood sugar and having an endocrinologist involved in their care is also important.
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