Nerve disease caused by type-2 Diabetes accounts for half of all amputations in the U.S., but a new treatment is helping patients keep their limbs. And it comes from a pregnant woman!
Diabetic sores on Rocco LoBosco's left foot robbed him of his little toe and doctors told him could lead to worse.
"There's still a chance that you might lose part of the foot, or the whole foot, or even the leg," LoBosco told Ivanhoe.
But by harnessing the power of amniotic fluid, Dr. Richard Jacoby, Medical Director at the Scottsdale Neuropathy Institute in Scottsdale, Arizona, says it's possible to avoid that.
"Amniotic fluid seems to meet the criteria to develop new tissue," Dr. Jacoby explained.
Amniotic fluid from a pregnant donor is injected into or wrapped around the nerve during decompression surgery. The stem cells in the fluid stimulate the affected area, telling it to heal the wound.
"I've done 16 nerves with this technique and all of them have restored their sensation," Dr. Jacoby said.
The new technique not only helps save limbs, but lives as well.
"Your life expectancy is 2 years after an amputation," Dr. Jacoby explained.
LoBosco had the surgery, and a month later, there is a noticeable difference.
"I had no feeling whatsoever in either of my feet," LoBosco said. "Now, I feel [my feet]…I couldn't do this before."
There are about 100,00 amputations each year in the U.S. Dr Jacoby says he also just used the treatment to help a woman with multiple sclerosis get out a wheel chair and start walking with a cane. The amniotic fluid comes from donors from an FDA approved laboratory.
BACKGROUND: People with diabetes are more likely to have a foot, toe, or leg amputated than other people. It happens because diabetics have blood vessel disease, which reduces blood flow to the feet, and nerve disease, that reduces sensation in the feet. These two conditions together cause sores and infections that may lead to amputation. Despite changes in care over the years, foot, toe, and leg amputations are still common. Research has been able to show links between risk factors like high blood pressure and high blood glucose and a person's chance of having a lower-extremity amputation (LEA). However, more research needs to be done in order to evaluate which patients with diabetes are most at risk. (Source: www.diabetes.org)
TYPE 1 DIABETES: The Wisconsin Epidemiologic Study of Diabetic Retinopathy was a long-term study of eye disease in people with type 1 diabetes that was conducted to find out how common lower-extremity amputations were in people with type 1 diabetes. It involved 943 patients. Researchers looked at how many patients got diabetes-related lower-extremity amputations over the years. They also looked at other possible risk factors like sex, age, age at diabetes diagnosis, length of time with the disease, blood glucose and blood pressure control, smoking status, weight, and the presence of other diabetes-related complications. Over the course of 25 years, about ten percent of the patients had an LEA. People with type 1 diabetes have a high chance of needing an LEA over the long term. Those with high blood glucose or high blood pressure and those who are heavy smokers are at a greater risk. (Source: www.diabetes.org)
NEW TECHNOLOGY: Building upon past research, Dr. Bruce Werber of InMotion Foot & Ankle Specialists developed a treatment for diabetic foot ulcers that prevents amputations. Dr. Werber gets the open, infected wounds to close by injecting them with amniotic fluid. "We now have amniotic membrane and fluid that is cryopreserved. So it can be used on anybody at anytime and anywhere and morselized so it can be injected. We don't have to have a live birth to collect it, and it can be harvested in very clean, sterile conditions. We inject it in and around the wound, and it enhances the healing," Dr. Werber was quoted as saying. (Source: http://www.samuelmerritt.edu) Dr. Werber says a diabetic ulcer happens when diabetics lose sensation in their feet. It's called neuropathy, and it happens gradually. He says diabetics may get a cut and don't know it. That cut could then become infected and the wound can erode through the skin and down to the bone. He says even a small diabetic ulcer can become life-threatening. In his study of 20 patients, they all had wounds that were unresponsive to other more traditional treatments. He said they injected the amniotic membrane around the wounds, and they started to close within days. The membrane has mesenchymal stem cells, which have all of the nutritional materials the tissue needs to heal. It stimulates the body very aggressively to start to create healthy tissue. Dr. Werber says of the 20 patients, all of their wounds have responded, and 90 percent have closed in the last year. "Everybody had progression, which is pretty remarkable for any medication," Dr. Werber said. (Source: http://www.azcentral.com/community/scottsdale/articles/2012/01/04/20120104scottsdale-podiatrist-develops-foot-ulcer-treatment.html)
Dr. Richard Jacoby, Medical Director at Scottsdale Neuropathy Institute, talks about how amniotic fluid can save diabetics' feet.
We're talking about diabetes and how there's a huge problem with people having to have their feet amputated because of it. How many patients are getting amputations?
Dr. Jacoby: There are probably about 100,000 amputations every year in the United States due to that problem. It's an incredible number, especially today in this world with modern medicine.
As a doctor, what is it like to have to tell someone they're going to have to get their foot amputated?
Dr. Jacoby: It's devastating. It's devastating to tell people who have diabetes, which is the main reason of amputation in the United States, but they have no pain at the end of this process. So, for them it's not that bad because they don't have any pain; they just have an infection. They usually become septic so they're happy to have that leg amputated. The real question is why do they get to that state in the first place? Why didn't they have early intervention? What we've been working on is trying to find out if there is an earlier detection system for people with diabetic neuropathy and diabetes itself.
Can you explain the breakthrough wi"Amniotic Fluid Saves Feet" Dr. Richard Jacoby th amniotic fluid?
Dr. Jacoby: Amniotic fluid is a really interesting substance. It's been around obviously for humans since the beginning of time. It's where the fetus is bathed in this fluid, amniotic fluid. In the United States we did the original research with the embryonic stem cells, but they were ethically put on the back burner. So, that technology went out of the country to China and Panama, but the scientists who worked on that substance came up with some amazing discoveries. Amniotic fluid seems to meet the criteria to develop new tissue. In our practice here we have used it to develop new bone and skin and to cure ulcers. We've had our first patient two weeks ago with multiple sclerosis who we used amniotic fluid on with a decompression surgery and she went from a wheelchair to walking with a cane, which is an amazing recovery.
If you have these degenerative diseases and you're in a wheelchair, you're facing an amputation, or you have an ulcer or a bone that won't heal, this is amazing technology. It's fairly simple too. We don't use it alone, although we can, but we usually use it in conjunction with a surgery or the new class four lasers.
How does it work?
Dr. Jacoby: Amniotic fluid is the normal fluid that allows the fetus to grow and differentiate their core structures in their cells that are undifferentiated. For instance, if you had a fracture in a bone that was not healing, we stimulate the bone by some means, either a laser or surgery, to create a signal. That signal is picked up by the amniotic fluid and the message to that bone is to create more bone, and that's exactly what it does as the fetus is developing.
How does it work for those facing an amputation? What is the process for that?
Dr. Jacoby: We would use it in patients who have diabetic neuropathy with ulceration. If we still have some nerve function left we can use that to clear up the ulceration, but it's not going to stop the process of the neuropathy itself; that's a whole other paradigm in treatment.
It won't stop the neuropathy, but it can keep people's limbs; correct?
Dr. Jacoby: Yes, they can help keep their limbs, but we have to talk about what causes neuropathy in the first place. The simple answer is sugar and that's what my book is about. My book focuses on what happens to the nerve and the answer is sugar. Sugar is camouflaged in so many different foods that you wouldn't think you were eating sugar, such as wheat, bread, or any grain. Carbohydrate breaks down to a simple sugar and the faster it's absorbed into your system the faster it produces what we call an insulin response. You can only put fat on your body by increasing your insulin. Fat does not cause fat. Dr. Mark Hyman has coined the word "Diabesity", which is a combination of diabetic metabolism along with obesity. All diabetics are not fat and all fat people are not diabetics, but the correlation is so strong and if you look down through the structure, it's sugar and not fat. The American population has been deceived because 50% of the American population over 65 is either diabetic or pre-diabetic. I doubt that the American public is stupid, but they certainly have been deceived.
If you look at the dietary pyramid, you're supposed to get six to eight grains a day; correct?
Dr. Jacoby: Six to eleven by the most recent outline. Michele Obama just changed that from a food pyramid to a food plate, but she's reading off the USDA criteria. Six to eleven helpings of grains a day is absurd, that's why we're all diabetic and this country is facing a financial burden with the healthcare cost. They're telling us to eat exactly the wrong things to eat. We need to be off grains, off carbohydrates, and eating good essential fatty acids. They come from grass fed meat like pigs, cattle, and chicken but they have to be grass fed, not grain fed. That goes for all the substances animals produce like butter and cheese. We need good fats like omega three fatty acids, not omega six fatty acids.
Its one thing to be able to pinpoint what we need, but how do we actually incorporate that in to our diets? Is it even possible to find a grass fed cow anymore?
Dr. Jacoby: You established the cause right there. It is not easy. 98% of all the grain in the United States is genetically modified and it's controlled by seven food companies. If you eat out a lot, which most of us do, you're going to be getting this type of food. Now, on your own you can eat healthy but it's a lot of hard work. Since we're all addicted to a high carbohydrate diet it's very difficult to get off of that diet, but it is doable. The people I put on the diet, I tell them if it tastes good don't eat it. You have to look at the labels. If you do that, you will lose weight and your diabetes will go away because it is a reversible disease in the beginning stages. Once you reach a point where you're fasting sugar is elevated, you're already in the fourth phase of the disease. Not the first or second but the fourth, and that means you're on your way to becoming a Type II diabetic which requires insulin. Remember, insulin is the only thing that causes fat accumulation so we go from a normal American diet to a genetically modified diet that's full of sugar and then we're going to treat them with insulin, which is the very thing that causes fat; it's a paradox.
Can you talk about the big breakthrough with the amniotic fluid as it addresses the amputation? What exactly does it do as far as rejuvenating that area?
Dr. Jacoby: One of the words we use is regenerative medicine, which is regenerating the normal tissues we once had. With amniotic fluid, it will bring back the normal tissue but there's a point of no return and that's why we have to do adequate testing to make sure we can make that reversal. It doesn't reverse past a certain point. That's what we really should talk about; how I got to this point in the first place. I had unique training with a fellow by the name of Dr. Lee Dellon, a professor of neurosurgery and plastic surgery at Johns Hopkins. That's how I got on this track. He has a technique for reversing the compression diabetic neuropathy causes and I got involved in the biochemistry of this question with him. We have a society called The Association of Extremity Nerve Surgeons who he has trained and we do the decompression surgeries, the same decompression that's done for the carpal tunnel and ulnar tunnel in the arm. It's the same procedure; we just do it on the lower extremity. When a nerve goes through a tunnel and becomes trapped like in carpal tunnel, we make the tunnel bigger. When we make the tunnel bigger, that's when we use amniotic fluid which will help regenerate the nerves that have been compressed. That's the basic place where we use this science.
This is used alongside a decompression surgery?
Dr. Jacoby: Yes, it is. This is the newer portion of that procedure. I said to Dr. Dellon, we're getting 85% excellent results with the surgery itself but we need to get a 100% if possible. So we've been working on the biochemistry and have been working with Dr. Cooke at Stanford who has an asymmetric dimethylarginine, a molecule that blocks the nitric oxide pathway that blocks the oxygen uptake in the nerve. That's another substance we work with.
If you didn't have the fluid and you just opened the tunnel, what would the results be?
Dr. Jacoby: We get 80% to 85% excellent results. Adding the amniotic fluid gives us better results than the original results; it gives a better outcome, less adhesions, and less recurrent rates than we normally would have had.
Can you quantify that?
Dr. Jacoby: Not yet because we've only been using the amniotic fluid for about a year and a half. I can't tell you exactly what that increase is going to be, but it's certainly increased. It's not decreasing the results of the original surgery.
Where are the fluids coming from? Could it be any donor or is it at the labs?
Dr. Jacoby: It's through an FDA approved laboratory, but the amniotic fluid is from pregnancy. Those fluids are freeze dried in some cases for the membrane and then provided as liquid in another form. They're injected or the nerve is wrapped with the membrane.
How long has the decompression surgery been going on for?
Dr. Jacoby: Dr. Dellon started his research in 1970 and he did his first case in 1984. He is a plastic surgeon by training and had done a decompression of the medial nerve, carpal tunnel, and the ulnar nerve on a patient who was diabetic. She said to him, ‘why don't you fix my legs?' and he said to her, ‘well that's just not done; everybody knows you do not operate on diabetics.' That was the prevailing wisdom in 1984. He thought it was an odd question and so he went back to the laboratory, did primate and rat experiments that showed when the tunnel was compressed in diabetic state, and he developed a surgical procedure for the lower extremities. I personally have done over 3,000 of these procedures and we haven't had one amputation in 13 years. We've had only a few recurrences of ulcers and we classify these into five phases. We have a Tinel's sign, which is if you tap on a nerve and can feel tingling, that means the nerve needs oxygen. In phase five the patient doesn't have a Tinel's sign and is deemed not curable by Dr. Dellon's definition. That's where we use amniotic. I've done 16 nerves with this technique and all of them have restored their sensation, which is amazing.
You said you have to get it at a certain point. What is the point of no return?
Dr. Jacoby: Traditionally it has been if there's absence of Tinel's sign, meaning no sensation. We call that insensate foot, and supposedly that is a foot we can't save but with amniotic we have saved 16 feet. Even with patients who have had partial amputations, it still returned their sensation.
Before that, if you didn't have amniotic fluid, you wouldn't even try the decompression surgery; correct?
Dr. Jacoby: I was reluctant to do that but now that I use it and have a much better success rate it's pushed this procedure to a new paradigm of treatment. Your life expectancy is two years after an amputation; so this is a lifesaving procedure.
Are there any good carbohydrates? Any grains you recommend?
Dr. Jacoby: I wouldn't; not in this country because they're genetically modified. We don't really know what's causing all these diseases, but diseases from MS to Hodgkin's Lymphoma have been linked to this process. There are a lot of diseases that are manifesting that we did not have 40, 50, 60 years ago; this is a recent phenomenon. It started 60 years ago with this philosophy but in the last ten years it's just been out of control. India is the number one country with diabetes now mainly because they have a larger population, but they adopted our disease, the disease of western influence, the disease of affluence. We export our foods and they import our diseases; it's as simple as that.
What do you eat?
Dr. Jacoby: I eat ranch type eggs with omega three not omega six if I can avoid it, but a lot of restaurants don't provide that. Olive oil, green leafy vegetables, all of the things my mother told me to eat that I didn't want to eat, but she was right. You need to eat green leafy vegetables. You need B6, B12, folic acid and lots of Vitamin C, and if you eat that you won't have these diseases. If you eat carbohydrates you will have these diseases.
Are fruits okay?
Dr. Jacoby: No, fruit is not an okay carbohydrate. Fruit is fructose, fructose is sugar, fructose goes to the liver and it causes what they call leptin receptors on the fat cells to be kind of dulled down and worn out so you don't know you're full. You'll keep eating more and more fruit thinking it's good for you but it's not good for you. Fruit, when you think back to the ancestral type diet, was only available a couple months out of the year. Going in to winter you wanted to eat fruit because it produces fat and then you had enough fat storage for the winter, but now we have Safeway's where you can get fruit every day and you'll get fat every day.
Do you advocate supplements at all?
Dr. Jacoby: I do. I think if you're eating in the United States you're obviously not getting all the nutrients. You need B6, B12 and folic acid. Where did the word folic acid come from? Foliage, that's what it means. Green leafy vegetables are what we need to eat and that's where we'll get enough Vitamin C and B vitamins. There are three biochemical pathways that really do the most damage and one's called the Maillard reaction, which means when you take a sugar plus a protein it makes things crispy. If you have a turkey and add sugar to it, it gets brown and crispy; that's what your nerves, arteries, and cartilage look like. Taking sugar plus a protein makes it crunchy so it doesn't glide. The second one is called the polyol pathway which is when sugar gets inside the nerve, goes through a pathway and makes sorbitol, an alcohol sugar that is very hydrophilic. This pulls water into the nerve causing the nerve to swell. So you have a nerve encapsulated by protein that's shrinking the tunnel and the nerve is expanding in that tunnel; that equals compression which shuts off the blood supply so you lose feeling in your toes, eyes, and every other body organ as well. That's what I call the global compression theory and that's the theory I'm working on with Dr. Dellon and Dr. Cooke at Stanford. Then there's the third pathway. The third pathway is the nitric oxide pathway and this is a little bit more complicated. L-arginine converts to nitric oxide which dilates blood vessels bringing more blood flow. Peroxynitrite, which is very invasive constrictive, shuts off the blood supply and is controlled by a substance called BH4, B6, Folic Acid, B12 and Vitamin C. So, if you're eating a lot of sugar that competes with vitamin C, you shut off the blood supply and get neuropathy. First it's fibromyalgia and all those types of diseases and then you progress up to a sensory neuropathy, a motor neuropathy, ulceration, osteomyelitis, amputation, and finally death. That's from simple sugar. Why isn't this known? It's in the literature. I can point to 10,000 articles that support what I just said. It's there but we like sweets and the food companies are going to sell you what you want.
Even if its low fat, is it still loaded with stuff that turns to sugar?
Dr. Jacoby: Look at Jell-O. It says no fat; well no kidding, it's all sugar. Why would you even say no fat when you're giving somebody sugar? It shouldn't even be mentioned but they know you're trying to avoid fat.
What about Vitamin D?
Dr. Jacoby: Vitamin D is getting a lot of press and it is important. Vitamin D comes from sunshine in the cholesterol in your skin and it's a process that makes Vitamin D. So yes, sun is good. I guess a lot of people have to take supplements but really you should get Vitamin D by going out in the sun every day. Not excessively but at least getting some sun every day; it's natural.
You say you want to stick with omega threes. Are there any oils we cook with that have them?
Dr. Jacoby: I think cooking does denature the protein, that's true. Olive oil is probably not the best cooking oil. I think coconut oil, grape seed oil and things like that are probably better. But you can pour olive oil all over your salads. You could drink it if you wanted and it's not going to hurt you, it's going to help you.
What about chocolate?
Dr. Jacoby: I looked at that too. Cocoa is good. It has some protective elements about it but it's very bitter. How do you make chocolate taste good, you add sugar. 98% of the chocolate sold contains high fructose corn syrup, that's what makes it sweet. High fructose corn syrup is the number one hidden sugar ingredient in the American diet. The better tasting the chocolate, the more sugar it has. Otherwise you would say it's bitter.
There has to be a level of balance that comes with this too, right?
Dr. Jacoby: I think so. If you have an opportunity to eat ice cream or chocolate, I don't think there's any problem with that because you know what you're doing. The problem is when it's masquerading as a good food or camouflaged in high fructose corn syrup and genetically modified grains and you don't know what you're eating. There's not a diabetic I treat who says they eat sugar. None of them say they eat sugar but why are they 300 pounds, why does their leg have a hole in it, and why are they dying from this disease? Because they don't know they're being deceived. If they knew these foods had all this sugar they wouldn't eat them, but by that time they've become such addicts it's almost impossible to get them off it.
What do you think about dairy?
Dr. Jacoby: Dairy is another mixed metaphor here. With skim milk you're taking the fat out of the milk and leaving the sugar. So, you shouldn't drink skim milk, which we were told to do. You're better off drinking the cream that has the good fat and throw out the sugar water, but you want it from cows that are grass fed. The pasteurization issue is another problem because we're boiling the milk and ruining the protein because we had the mass hysteria with tuberculosis and smallpox at the beginning of the last century. That's why we have all these laws to help protect us but really they harm us.
What is the negative? It doesn't retain the protein?
Dr. Jacoby: It's denatured because it's pasteurized, meaning it's boiled which knocks out the natural protein.
Can you talk about your diet quiz?
Dr. Jacoby: We haven't fully developed the quiz yet for the book, but basically most diabetics I ask if they eat sugar say no. So, the quiz questions are related to what they're eating, like oatmeal and bread, that people don't think have sugar but they are. For instance, what is higher on the glycemic index, a Milky Way or a Parsnip? A Parsnip is 97, where Milky Way is 45. People wonder how could that be? Remember that in supermarkets you're going to buy the sweetest grape or the sweetest apple, not the bitter one. So, through hybridization they're going to breed the things that are the sweetest and tastiest thing to sell; that's just natural. Now, when you go back 40 or 50 years, if you had a grapefruit most people put sugar on it because they were very tart. You ask a person if they put sugar on a grapefruit today, no one does because it's ten, maybe 20 times sweeter than it was 40 years ago. So, we're eating sugar by many different methods and fruit is probably one of highest methods of eating fructose, but vegetables as well. Carrot is a very high sugar vegetable. I noticed about ten years ago that I like carrots now because they have sugar. Carrot juice is loaded with sugar. A lot of vegetables are high in sugar, like onions have high sugar content. Kale is very popular now and that's a good substitute because it has good flavor, B vitamins, and folic acid. So the greener they are, generally the better they are. With kale you know they're on the right track, and those people can make the transition because they get it.
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