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Fighting Diabetic Amputation

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PHILADELPHIA, Pa. ( Ivanhoe Newswire) - Worldwide, an amputation is performed every 30 seconds on a person with diabetes. Right now researchers are testing a new way to improve circulation and save limbs with a patient's own cells.

Claudell Jones is diabetic, so when he started feeling pain in his feet he got help fast. He knew his high blood sugar raised his risk for a serious infection in his foot.

"More than likely it would have spread and instead of losing the toe, I would have lost the whole leg," Claudell Jones told Ivanhoe.

Nerve damage and poor circulation in diabetics' feet can lead to ulcers. If not treated the toe, foot, or even part of the leg may have to be amputated. Claudell was lucky. Doctors were able to improve his circulation with surgery, but every year tens of thousands of diabetics lose limbs. Doctor Eric Choi from the Temple's Limb Salvage Center is testing a new procedure that would give patients another option to save a foot, or leg.

"In those patients where we cannot do surgery to restore blood flow, we actually try and see if we can improve the flow by creating new blood vessels," Eric T. Choi, M.D., FACS, an associate professor and chief of the division of vascular surgery at Temple University School of Medicine, explained.

It's called angiogenesis. Choi and his colleagues are testing a therapy that prompts the body to regrow blood vessels. Doctors extract bone marrow from a patient's hip. The marrow is stimulated to produce new cells. Those cells are re-injected into patients, and create brand new vessels needed to improve blood flow. Choi said the earlier patients seek treatment, the better the outcome.

"If we can help them early, we don't have to have 150 thousand patients have foot or leg amputations," Dr. Choi said.

A new procedure that could help diabetics like Claudell keep their limbs and quality of life. Doctor Choi said angiogenesis may increase a patient's risk of developing cancer, so it may not be an option for all patients. Researchers hope to enroll six hundred people nationwide to study the therapy.

RESEARCH SUMMARY

BACKGROUND: Diabetes affects 25.8 million people of all ages. Diabetes complications include nerve damage and poor blood circulation. These problems make the feet vulnerable to skin sores (ulcers) that can worsen quickly and are difficult to treat. Proper diabetes management and careful foot care can help prevent foot ulcers.  When foot ulcers do develop, it's important to get prompt care. A non-healing ulcer that causes severe damage to tissues and bone may require surgical removal (amputation) of a toe, foot or part of a leg. ( Source: Mayo Clinic)

CONTROLLING DIABETES: Nerve damage or neuropathy is a common complication of diabetes, especially among people who have had the disease for many years. Poor control of diabetes, such as prolonged high blood sugar, low insulin levels, and high blood pressure, are believed to be major contributors to diabetes-related nerve damage.
Recommendations for diabetic people from the CDC's National Diabetes Education Program include:
• Wash your feet every day, keep feet soft with lotion or petroleum jelly, smooth corns and calluses gently, and trim toenails frequently
• Wear shoes and socks at all times to minimize the risk of injury.
• Protect feet from extreme heat and cold
• Remain active and do other things to promote blood flow to feet
• Discuss foot care with your doctor ( Source: CDC)

HELPING SAVE LIMBS: Temple University Health System we will be the first hospital in the region to participate in a trial called REVIVE – which involves injecting enhanced bone marrow into a patient's leg in order to promote the growth of new blood vessels. This approach is called therapeutic angiogenesis, and the hope is that the new blood vessels will improve blood flow in the leg.

"By stimulating the bone marrow, there will be more of  these cells that can grow new blood vessels that are available, and in many cases, the body knows exactly what it needs to do when there is a problem," Dr. Eric Choi, MD, FACS, Chief of Vascular Surgery, told Ivanhoe.

INTERVIEW

Dr. Eric Choi, Chief of Vascular Surgery and Director of the Limb Salvage Center at Temple University, talks about saving diabetics from losing limbs and how their own body could be the key.

Can you talk about diabetes and amputation?

Dr. Choi: Usually diabetes and amputation occur in older patient population with peripheral artery disease - circulation problems. While it's true that younger patients are diagnosed with diabetes, but it is not often that they also have peripheral arterial disease. Now we are seeing the combination in younger patient population as well.

Can you talk about the Limb Salvage Center?

Dr. Choi: We have now at least 10 specialties involved in the Temple Limb Salvage Center. We can offer comprehensive treatment plans at the Limb Salvage Center providing conventional options as well as more novel therapies. I mention novel therapies because not everybody can have their problems resolved with surgery or wound care alone. In some cases, there are no interventions that can be offered, whether it is balloon angioplasty or bypass surgery. We are first center in the Philadelphia area to provide the angiogenesis clinical trial which can potentially offer growing new blood vessels in selected patients who would meet all the criteria. We are enrolling patients currently.

How does the angiogenesis therapy works?

Dr. Choi: We look at patient's bone marrow as sort of the fountain of youth if you will. You know how a patient loses blood during surgery or trauma, and the lost blood is replenished somehow without a transfusion? Well, that is the bone marrow. Bone marrow can repair damages to other parts of the body. Another bone marrow repair process could be growing new blood vessels in case of a patient with severe circulation problems and also diabetes. In those patients whom we cannot do surgery to restore blood flow, we will try to improve the blood flow by creating new blood vessels.

Tell me a little bit about the next step.

Dr. Choi: The clinical trial that we started in Saint Louis before I came to Philadelphia is about stimulating the bone marrow with medications to make more blood vessel-producing cells available. I believe in many patients, the body knows exactly what it needs to do. These cells home to site where they are needed. They just have to be stimulated to get the process going. That is one clinical trial. Another clinical trial, we take these bone marrow cells from patient's bone marrow, and then inject them directly into the affected leg to grow new blood vessel. Currently, we are enrolling at Temple with the second approach where we collect bone marrow cells and reintroduce it into the affected limb.

Usually from the hip, you said?

Dr. Choi: Yes.

Are there any potential side effects for something like this?

Dr. Choi: There are some side effects. We do have to screen patients for active cancer so that we do not introduce new blood vessel growth in this setting that could potential worsen the cancer. Another potential side effect is in the patients with diabetes and problems with their vision. It is neoangiogenesis that occurs in the setting of diabetic retinopathy. We do not want to make this situation worse by growing new blood vessels in the eye. The good thing about the current clinical trial, which collects bone marrow cells and inject them into the leg, is that angiogenesis is potentially limited to the affected leg.

Who is an ideal candidate for this?

Dr. Choi: The ideal patient is a patient who has been told that he or she needs a leg amputation in the near future. They are told that everything possible has been tried and that there is no way that the leg can be saved. We want to enroll these patients as early as possible. If these patients have an infection or gangrene, we may not have enough time to grow new blood vessels to prevent this complication. If we get to them early enough, then we may have that opportunity to grow new blood vessels. The ideal candidate is that patient who has been told that he or she needs a leg amputation because there is not good enough blood flow.

What are the parameters? Is it a multicenter or just here?

Dr. Choi: It is a multicentered clinical trial.

How many patients are you looking?

Dr. Choi: We are hoping to enroll about 20 patients at Temple. They will be randomized for placebo or the injection. At the national level, over 600 patients will be enrolled.

What ultimately is the goal? What do you want to find from this trial?

Dr. Choi: It would be to save them from having a leg amputation.

Can you tell me about Mr. Jones?

Dr. Choi: Fortunately for Mr. Jones, we did found him early enough. He had all the major issues - circulation problems, diabetes and so on. He presented with non-healing toe and foot ulcers. The ulcers were very painful because they were infected and there was not a lot of blood flow. Literally, the toes were dying. We managed to restore blood flow to the foot with conventional therapies like balloon angioplasty and stenting, which he had, and we were able to just do a limited toe amputation to 2 of the toes. We were able to save the rest of the toes and foot, and now, he is doing quite well walking without a problem.

Had he not come in for help, had you not caught him early, then what are the steps?

Dr. Choi: The possibility is that the foot would have gotten infected to the point that he would require a leg amputation to control the infection.

Is Mr. Jones someone for whom this trial would have been beneficial?

Dr. Choi: No. Actually, there are many patients who can improve their blood flow in a conventional way without having to enroll in clinical trials. In Dr. Jones' case, we found out that we were able to provide conventional therapy to improve the blood flow. Therefore, he would not have qualified for the angiogenesis trial. Interestingly, if he were to continue to smoke and to ignore the problem to the point where his circulation problem was not amenable to a conventional therapy, then he would qualify.

What ultimately is the goal for you and for the patients who come through here?

Dr. Choi: We want to provide the kind of care that is comprehensive and easy to follow, so that our patients can get the care without having always to decipher the complexity that is our current medical care. We want have our patients to come to one location – Temple Limb Salvage Center, to follow simple directions, to know that we care, and to get the comprehensive management plan without having to chase down specialists.

What is the percentage of diabetics and people with PAD that wind up having to have amputations?

Dr. Choi: In the US, over 150,000 patients need either foot or leg amputation every year. In most cases, leg amputations are preventable.

Is there the potential that someday there will be no amputations?

Dr. Choi: Yes. We are hoping to get to that point where we can either prevent diabetes or peripheral artery disease or provide early management of their diseases. In the case that they do have advanced disease, we hope that we can either provide conventional therapy to improve the blood flow as early as possible or introduce angiogenesis or other novel therapy if there are no conventional options.

Is there anything you think people need to know?

Dr. Choi: If you have diabetes and/or circulation problems, then you need to look at your feet on a daily basis. You need to make certain that you do not have any blisters, open sores, or infections on your toes or feet and seek help immediately if you have them. I believe it is also important that you are persistent in your effort to get medical help when you have these issues. Do not give up just because the first specialist says that this problem is not his or her area of expertise. Find that specialist who can help. In the meantime, we hope to fill this void. It is our area of expertise.

Is there something specific that you do to prevent diabetes?

Dr. Choi: Yes, I try to exercise regularly and to eat healthy. I also try to keep my weight stable.

FOR MORE INFORMATION, PLEASE CONTACT:

Jennie Wong, RN, CCRP
Temple University
(215) 707-5340

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