#: 789608 S8/Complications [DIABETES] Sb: #Zopolrestat /neuropathy Fm: Eric Kadison 74766,2002 Hi again everyone, I just found a research study in progress to evaluate the safety and effectiveness of a Pfizer drug called Zopolrestat on diabetics with Peripheral Symmetrical Polyneuropathy. The study is for 18 months. They are administering either 250 mg or 500 mg of the drug (or a placebo). During the test period, there is monthly Dr. visits with blood and urine analysis. The study appears well managed with due attention to side effects and patient management. The problem with the study is that they want 2 sural nerves!! They biopsy one at the start of the process and one at the end. The nerves removed are on the outer side of the ankle, where a diabetic can have circulation problems. The consent form says 40% of the subjects suffer from numbness. Usually worst in the first week after the biopsy. 33% have occassional unpleasant or painful numbness a year after the biopsy. The tales go on. I asked my endo. He said to count on pain and numbness from the biopsy. Anyone out there know anything they can add about this. Is the biopsy really that risky. Is this something I should seriously consider taking part in? Eric -Eric Kadison Fm: SYSOP-John Davis 73455,43 Eric, One of the other SYSOPS pointed me to your message. The answer to your question is yes, there are others out there (I just "Wound up" my part in said study, and thanks for reminding me of somethign I needed reminding of) The nerve biopsies were not as bad as they sounded, Course I may have been one of the lucky ones. They will want you to bring a driver however when you have them. (They don't want you to drive home) My first was about 20 months ago now, That one I had some soreness and extream senestivity to touch where the nerve ended (I once banged the leg just there, about 2 weeks after surgury, nearly passed out, Don't recommend hitting that spot hard, but then, that applies biopsy or not). I can still find that spot on my leg if I'm looking for it (however today I have to look) The hardest part is keeping the leg elevated and dry for the required 2 weeks The second biopsy was Jan 30, and on that one healing seems to be going faster (Though it was more senestive over a larger area when I first walked, and I do mean WALKED, out of the hospital, It seems to be far less senestive to touch now than it was (IE: I can wash the leg and run a bar of soap over the spot without enough pain to complain about, though I still feal a twinge) Of course you get neurological exams too. And they have a new machine they are using to test neural response I'm told... And it don't sound like fun (I missed out on it as they were still installing when I finished the study) but then the biopsy did not sound like fun either. And you get a rather large number of "Free" lab tests and the like. All in all... I had a good time (I had a nurse cordornator who happens to share my taste in a few things like Science Fiction and humor and this really helped) And now they are talking about another study on the long range effects of this stuff they want me in. Worst part... When the doctor actually cuts the nerve, They use a local and/or nerve block. When he cuts the nerve, no amount of nerve block will keep you from feeling it. However it's very quick, and then it's done. And again, The first time was worse than the second (But then I had a different doctor the first time. Can't complain however, Both were very good) They gave me a prescription for pain killers. The first time it was Tyenol 3 w/codine (I tossed the paper in the biohazard bag as I did not think I would need it, I was right, Used about 4 asprin is all) Second time, Since I would not take T-3 w/codine, they tried Vicodan, A very simular (Tyenol/Narcotic) product. I still have them. ALL of them. Did not even need the asprin the second time. I do understand that this is not typical however. Most people suffer more from pain than paranoia about mind altering drugs . Fm: Eric Kadison 74766,2002 To: SYSOP-John Davis 73455,43 John, Thanks for your detailed account of the Zopolrestat study. A few questions: >> The hardest part is keeping the leg elevated and dry for the required 2 weeks << Are you supposed to stay off the leg for 2 weeks? No going to work? What kind of Doctor's did the biopsy's: The lab locally told me that they switched to a plastic surgeon recently to reduce the rate of problems. How's your circulation? Do you think the nerve has grown back? Do you have feeling in the area where the nerve was removed? In my case, healing in my feet has been getting steadily worse and cuts barely heal any more without external aids. My concern is that the nerve will never grow back and I'll be left with numbness on the side of my foot. All the blood work, including a challenged C-peptide, and the neuro exams seem like a great incentive, but I remain concerned about the biopsy's. BTW, what was your experience with the performance of the medicine? Eric -Eric Kadison Fm: SYSOP-John Davis 73455,43 No, not stay off it. You can walk (I walked out of the hospital) Just keep it elevated as much as possible. This is to prevent blood from pooling in the leg. Thus you rest it on a chair or a pillow on a chair. I'm not convinced this is 100% improtant as I was a very bad boy in this reguard on the second leg, and it came out better. . .The doctors who operated on my nerves were neuro surgons (Actually makes sense) Though for this operation just about any "Cutter" should be able to do it. The only special skill needed should take less than five minutes to teach (The actuall cutting of the nerve. That's the only thing that's non-standard) . .My circulation seems to be good per assorted doctors. . .And no, I don't think the nerve has grown back. The outside of the foot still seems to have no feeling. However I do have to look for the "dead" part as it is a part of the foot that almost never sent me any "signals" anyway. . .As to healing in my feet. Well I can't advise, It has been some time since there was anythign there that needed healing. . .But the numbness in the foot, as I said, I only notice when I think about it .Even the one they just did. I don't notice the numbness in. . .As my study nurses said. This bit of nerve is ranked last in improtance. If you had nerve damage elsewhere in your body, this is the one they would use to replace it. And when you compare some numbness in the side of the foot with numbness in the entire foot (Which will happen if neuropathy contines) you find that at the very worst you are in a break even situtation with this study. You might come out ahead. Chances of loosing are slim at the best . .Oh yes.. At least where I went they gave me a nice T-Shirt too (I don't know if this is a policy of the center I was at or of the study) but I sure would not enter the study just for the shirt (It's .gif'ed here somewhere) (Message in Diabetes) #: 789956 S8/Complications (CIS:DIABETES) 09-Mar-98 10:30:10 Sb: Zopolrestat /neuropathy Fm: SYSOP-John Davis 73455,43 To: Eric Kadison 74766,2002 Replies: 0 TID: 3806 Par: 789945 Chd: 0 Sib: 0 No, not stay off it. You can walk (I walked out of the hospital) Just keep it elevated as much as possible. This is to prevent blood from pooling in the leg. Thus you rest it on a chair or a pillow on a chair. I'm not convinced this is 100% improtant as I was a very bad boy in this reguard on the second leg, and it came out better. The doctors who operated on my nerves were neuro surgons (Actually makes sense) Though for this operation just about any "Cutter" should be able to do it. The only special skill needed should take less than five minutes to teach (The actuall cutting of the nerve. That's the only thing that's non-standard) My circulation seems to be good per assorted doctors. And no, I don't think the nerve has grown back. The outside of the foot still seems to have no feeling. However I do have to look for the "dead" part as it is a part of the foot that almost never sent me any "signals" anyway. As to circulation and healing in my feet. Circulation still seems good to my doctors. Healing... Haven't tested it lately (other than the surgery and that healed just fine). As to the loss of feeling... This is the outside edge of the foot. I have to test it to see if I have lost feeling or not. I don't normally USE those nerves Thus I don't miss them one bit. They take a bit much for regeneration to occure. But even if they don't grow back, It hasn't been a problem for me. Of course, I don't walk on glass or anything (At least not with my shoes on, and they are somewhat puncture resistant)