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Laser treatment for nail fungus

Discussion in 'General Issues and Discussion Forum' started by Cameron, Jan 4, 2009.

  1. Dr. Chicago:

    Forums for medical professionals, such as Podiatry Arena, are only as good as the members who contribute to the site. In addition, Craig Payne, the founder and administrator, along and his other "helpers", are the main reason that Podiatry Arena is what it is today....the best source for podiatry-related information on the internet in the world.

    If you are to thank any one person for Podiatry Arena, thank Craig. :drinks
     
  2. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Dear Colleagues:

    Please see the new article in the Wall Street Journal, describing the Laser ToeNail Fungus market. The article is factual, and well done by the Health Writer Laura Johannes.

    A couple of sections from the article are below:

    In clinical practice, results have varied, according to doctors who have used the laser. New Jersey podiatrist Anas Khoury, who has no affiliation with any laser company, says he has been using Nomir's Noveon laser for toenails for about four months and says it works in about 80% of his patients. "My patients and I are very happy with it," he adds.

    Philadelphia podiatrist Warren Joseph, who is a consultant for Nomir and a former consultant for PinPointe, says: "I think it is a really interesting, viable alternative but I want to see published data." His advice to patients: "Ask for the evidence—and not just before-and-after pictures."

    So far only Nomir has published evidence of efficacy, but its study is small and short term. A company-funded study of 34 patients and 26 treated toes published last year in the Journal of the American Podiatric Medical Association found that after four laser treatments, 85% of the nails showed new growth without fungus. Of the total, 65% showed at least three millimeters of clear new nail and 26% had at least four millimeters.

    Here is the link:

    http://online.wsj.com/article/SB100...6158351630076320.html?KEYWORDS=LAURA JOHANNES

    Best Regards,

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    www.noveoninternational.com
    ebornstein@nomirmedical.com
    Cell: 508-380-9866
     
  3. ChicagoChiro

    ChicagoChiro Member

    That all sounds just fine. But what about much less expensive lasers like a ND YAG 1064/532nm? They cost only $2,000 to buy one, not lease. Or a low level laser at 808nm? Those cost under a thousand dollars to own. All would be used off label but aren't podiatrist licensed to use lasers off label, meaning not FDA approved? I already know podiatrists who are using them with at least as must success as the FDA approved lasers.

    I know some that are, and are getting equal results as the FDA approved fungal lasers.
     
  4. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member


    ChicagoChiro:

    Unless it is published in a peer-reviewed journal, ALL data is simply anectdotal.

    I am the author of 15 peer-reviewed publications in the last 10 years in the laser space, across multiple disciplines of medicine, photobiology and infectious disease.

    I know you seem to be very high on the "mine is as good as yours" issue, but you simply need to further educate yourself.

    Cold near-infrared lasers do not kill bugs. There is peer-reviewed literture to suggest that they actually stimulate microbial growth.

    One Nd:YAG is not like other Nd:YAG's if the power and pulse times are different. One could be therapeutic, where the next could very well be dangerous.

    I could go on, but would suggest some reading, before simply buying a laser, and using it on patients to treat an infectious disease, or any other medical issue.

    Best regards,

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    www.noveoninternational.com
    508-380-9866
     
  5. poddoc

    poddoc Member

    I for one agree with Dr. Bornstein and have purchased a "podiatry approved" evidence based laser> I am much more comfortable knowing the technology and science for proper care of my patients. Relying on collegues accounts for results isnt and shouldnt be considered the standard in todays data driven society. I think that buying inferior products at your patients expense is not good medicine.
     
  6. ChicagoChiro

    ChicagoChiro Member

    I have read dozens of reviews from podiatrists who have used both FDA approved fungal lasers and generic type lasers. All reviews are by nature, 'anecdotal'. I suppose manufacturers should pick out the ones that suit them best. Reviews are mixed for both types.
    The bottom line is this: If you take just a minute to learn the specifications of an FDA approved laser, you can find a much cheaper generic model. MUCH CHEAPER.
    Let's not surgarcoat this. It's all about money and territory. Now if a state licensing board or a malpractice carrier forbids the podiatrist from using an off label laser, that would be different.
    I've been a practicing chiropractor for over 30 years. It didn't take me 30 years to sort out the abundance of bs equipment manufacturers try to pass off as fact.
    In an earlier post I mentioned Decompresssion Tables used to treat disc herniations. Some claim FDA approval (the $120,00 table manufacturers) and some don't (the $8500 manufactuers). No shock here--they both work the same.
    The common thread here is this: Spinal decompression, as performed by chiropractors on those tables to treat disc herniations is not covered by insurance. It is a cash business. So the chiropractor only has to be accountable to his patient and doesn't care what insurance companies say. Likewise, it is my understanding that laser treatment for onychomycosis is also not covered by insurance as a stand-alone treatment. Again, the podiatrist only needs to be accountable to his/her patient.
    When making an informed decision about what makes the most fiscal sense, don't forget to use common sense.
     
  7. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member


    ChicagoChiro:

    Lasers are NOT decompression tables, they are energy radiating devices, each with their own nuances and specific abilities. Here is an example of why peer reviewed data and CORRECT manufacture settings for each laser and each disease are important.

    First, what is the proper "pulse width" for a procedure, and does the device give that pulse width?

    Time Conversion Factors for laser “pulse” Math

    1 sec = 1,000 milliseconds (ms) (103 ms)
    1 millisecond ms = 10-3 = 1/1000 second = 0.001 sec
    0.001 sec = 1 millisecond (ms)

    1 sec = 1,000,000 microseconds (µs) (106 µs)
    1 microsecond µs = 10-6 = 1/1,000,000 second = .000001 sec
    0.000001 sec = 1 microsecond (µs)

    10 microseconds = 1/100,000 second
    100 microseconds = 1/10,000 second

    Second, what is the Power density and Energy Density that you are using for the procedure, and can the laser actually put out the correct dose?

    Laser Math Calculations

    The Output Power of a laser device, refers to the number of photons emitted from the laser at a given wavelength and is measured in Watts. 1(W) = 1000 mW

    The Power Density of a laser beam measures the potential thermal effect of laser photons at the treatment irradiation site/area of tissue. Power Density is a function of Output Power and Beam Area, is calculated in (W/cm2), and is the value is obtained with the following equation:

    1) Power Density = (W/cm2) = Laser Output Power (W) / Beam Diameter (cm2)

    The Total Energy delivered into a tissue area by a laser system operating at a particular output power over a certain period of time, is measured in Joules, and is obtained with the following equation:

    2) Total Energy (Joules) = Laser Output Power(Watts) x Time(Sec)

    It is essential to know the distribution and allocation of the Total Energy (Joules) delivered into a given tissue area, in order to correctly measure tissue site dosage for maximal beneficial tissue response.

    Total energy distribution will be measured as Energy Density in (Joules/cm2).

    The Energy Density is a function of Power Density and Time (sec) seconds, is measured in (Joules/ cm2) and is calculated as follows:

    3) Energy Density (Joules/ cm2) = Power Density (Watts) x Time (sec)

    Usually to calculate the Treatment Time to deliver a dose of laser energy to a given volume of tissue, a clinician will need to know either the Energy Density (J/cm2) or Total Energy (J), as well as the Output Power (W), and Beam Area (cm2). Treatment time can then be calculated with the following equation:

    4)Treatment Time (seconds)= Energy Density (Joules/cm2) / Power Density (W/cm2)


    THIS IS QUITE A LOT OF MATH for a doc to figure out with an "Off Label" laser. Who is going to do this math before they begin a procedure?

    With the brand name FDA lasers, this math and the dose is generally pre-programed in for a given procedure. That is a HUGE difference.

    If you disregard my above discussion for an "off label" laser, to use on your patients, without fully understanding the energy and the dose, you do so at your own risk.


    Best regards,

    Eric


    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    www.noveoninternational.com
    508-380-9866
     
  8. ChicagoChiro

    ChicagoChiro Member

    Even with the high tech 'math' for FDA approved fungal lasers the reviews are mixed and no better than off label lasers with similar specifications. At least that's what I read just in this thread alone.
    Nothing speaks louder than clinical success, or for that matter, clinical failure.
    Years ago I was convinced double-blind studies for any medical device or drug was the gold standard that measured reliability and safety. Now I'm not so sure. Drug studies are mostly funded by the same drug manufacturers who sell those drugs, of which the majority have been pulled off the market within five years due to FDA safety concerns. So who do you believe? I put more faith in experienced practitioners than I do in drug/device manufacturers.
     
  9. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    ChicagoChiro:

    You still completely miss the point.

    This is not high tech 'math' we are talking about. The equations I listed above are simple algebra, with basic constants (power output and spot size) and basic variables (treatment time and pulses within the treatment time).

    This is not magic math with money to be extracted from Dr's to let them in on the magic. It is however time, effort, and education.

    Written into the algorithms for Correct Dose for these systems is years of data about all of the constants and variables that show Efficacy and not Damage for the treatments being performed.

    If someone wanted to follow the equations I listed above (again simple algebra) and they understood the parameters of the device they were using, the tissues they were treating, and how laser energy interacts with these tissues, they would most likely be able to calculate an effective dose with trial and error.

    I have met very few physicians with the skill and or inclination to attempt to calculate the correct dose for every patient in the middle of a busy day with a laser. They would rather push one button, and have tried and tested parameters already set in the device.

    Please do not leave other Docs with the impression that this is an easy task, because it is not.

    I see no further need to discuss this with you. I wish you success in your therapies.

    Best regards,

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    www.noveoninternational.com
    508-380-9866
     
  10. ChicagoChiro

    ChicagoChiro Member

    I didn't know I was discussing this with anyone in particular. It's for all to see.
    My analogy to Spinal Decompression should have been clearer. The $120,000 table manufacturers have a host of computers which, according to them, calculate the 'exact' amount of traction a specific patient should be getting based on dozens of parameters such as body type, weight, MRI findings, age, medications, scar tissue, and so on. The $8500 tables don't use computers. It's up to the practitioner to determine the angle of the patient on the decompression table, how long, etc. The bottom line is this: Both the expensive tables and the cheaper tables get the same results. According to the practitioners who have used both, the results are the same. Some patients enjoyed relief while others didn't. But the type of table didn't matter even though the more expensive manufacturer said it did.
    From what I've seen here and by talking to podiatrists who have used lasers to treat onychomycosis, it doesn't seem to make a lot of difference as far as clinical outcome which laser they used, a generic model or an FDA approved model. The podiatrists who got the best results instructed their patients on home care (applying topical medications) and proper hygiene. Regular debridement was also a big part of their success. Any laser seems to be about half of the overall treatmenet for onychomycosis.
    I realize my opinion is just that, an opinion, but from what I've seen almost any class IIIB or IV laser would work for fungal nails as long as it's used with the other procedures I mentioned above.
     
  11. poddoc

    poddoc Member

    I dont mean to be disrespectful, but i DO feel the type laser you use is very important. Saving a few bucks is pound wise and penny foolish. I hope you never have a malpractice case against you because if you were using an unapproved laser the opposing council will rip you apart. Dont be naive, we live in a very litiginous society and you need to be SMART and protect yourself. If this isnt a reason than as I stated before evidence based medical practices is a great reason. Your playing devils advocate to the enth degree. It doesnt make sound sense to me.
     
  12. charlie01

    charlie01 Active Member

    Eric, I have a question for you here: was your laser used "off labal" until you received new FDA approval that extends its usage to fundal nails?
     
  13. charlie01

    charlie01 Active Member

    Frederick George:


    Hope you and your family are OK.

    It has been reported at least 65 were killed by yesterday's earthquake in Christchurch.
     
  14. RiverRider

    RiverRider Member

    Questions for those of you providing laser treatment -

    1) Do you debride all infected nails or only those that have thickened?

    2) After laser treatment do you have the patient apply a topical antifungal and if so for what period of time?

    3) If a patient has a susceptibility to onychomycosis then I would assume that a complete treatment should include a plan to address the infectious fungal material remaining in a patient's living environment.

    For avoiding reinfection what do you suggest to your patient -

    a) Shoes - Do you suggest that all existing shoes (even if they've only been used with socks) be discarded or do you suggest some method of killing the fungi in them?

    b) Socks - In another thread a study was linked that showed that socks contain viable fungi even after machine washing therefore they remain a source of reinfection. Do you suggest all socks be discarded?

    c) Bedding - If socks contain viable fungi after machine washing we can hypothesize that sheets and blankets that have come into contact with the feet would also contain viable fungus capable of reinfection. Do you suggest discarding all bedding or some form of killing viable fungi that remains on the bedding?

    d) Floor surfaces in the home?

    - Do you suggest the patient use bleach or another product on hard surfaces to kill fungus?

    - Do you suggest a method to remove or kill fungi on and in carpets?

    e) Nail clippers? Do you suggest the patient discard the old ones or some form of cleaning before resuse on the laser treated nails?
     
  15. Frederick George

    Frederick George Active Member

    If you pay for an exclusive on an expensive machine, or if you are selling an expensive machine, certainly that is the ONLY machine. Ask any Mercedes owner.

    Does anyone else care that 65% of nails had 3mm of clear growth? So what! That is not a cure. At $1200-$1500 per treatment, not many patients can afford follow up treatment to achieve a cure.

    In order for me to effect a complete cure after that first 3mm of clear nail growth, I have to laser the nails again. And again, on a monthly basis until they are cured.

    I couldn't afford do that if I was paying $4,000/month lease and $200 per treatment.

    That's the difference.

    To prevent recurrence, Lamisil cream, or similar, every day. The patient can't rid the world, or even their house of fungus.

    We are doctors. We have no superiors, only peers. We are supposed to think for ourselves.

    Cheers
     
  16. Fred:

    How did you all fare in the earthquake? Hopefully you and your loved ones are well and things are getting back to normal in that lovely city.
     
  17. charlie01

    charlie01 Active Member

    I asked Hamish Dow the same question (see above), but I would appreciate feedback from anyone as well.
     
  18. Frederick George

    Frederick George Active Member

    Thank you for your kind concern, Kevin. We live outside town, so we weren't directly affected.

    The earthquake has displayed New Zealanders at their best. Everyone is concerned, and have helped anyway that they can, taking in strangers who have lost their homes, students shoveling silt on their (enforced) school holiday, cooking hot meals and flying them in by helicopter for strangers who don't have power and water.

    I am proud to live here.

    Cheers
     
  19. arcom

    arcom Member

    I specifically registered for the Podiatry Arena to afford me the opportunity to post my personal experience with the PinPonte laser treatment. I've read, start to finish, the postings beginning two years ago when I underwent the treatment. The cost was high ($1100) but included four follow up examinations and a re-treatment after one year if needed (it wasn't). In spite of the high relative cost it was for me a no brainer. I am a 61 year old male who has fought the toenail fungus battle since my year in Viet Nam (1969). I have managed to eliminate the fungus in all nails save both big toes which have proven resistant to all treatments including nail lacquer and Lamisil tabs.

    In 2008 I auditioned for a long term position (in my profession 2 years is long term) with an agency that represents a large discount mail order catalog in the fashion-ware industry. To my dismay I was not hired. When I pushed the issue, the talent coordinator told me I was a shoe in until the portion covering summer clothing was conducted. Apparently this man considered toenail fungus in the same arena as AIDS. He did however schedule me for the next modeling session, six months off with the admonition that it was contingent on ridding myself of the fungus.

    The long and short of it is I underwent the treatment (and deducted it as a business expense) two years ago. One treatment, two followups and I was done. My toes have remained infection free and the only routine I follow is a daily topical over the counter treatment. It matters not to me why or how the laser works; just that it did. It cleared up my condition while allowing me to continue in a career that becomes very thin as one ages.

    PS
    Look for my toes in the Summer 2011 Blair catalogue!
     
  20. RiverRider

    RiverRider Member

    Thank you for taking the time to post your experience and congratulations on your success!

    What are you using and will you continue the over the counter topical permanently?

    Did you do anything to address your shoes, socks, and living environment after the treatment?
     
  21. charlie01

    charlie01 Active Member

    arcom, nobody says here that PinPonte doesn't work. However the issues are (1) whether the success rate is as high as claimed by the manufacturer, (2) the high success rate is because of laser or because of combination use of PinPonte laser and antifungal topical, and (3) whether other types of lasers can achieve the same results.

    I posted a link to a website in which the author complained about poor results from the PinPonte (only 30% success rate).

    Hamish responded by saying "I have been using a PinPointe for about a year and a half. One needs to understand the technique of use of hte equipment well and in my opinion have good debridement technique..." So RiverRider and I asked if the nails with normal thickness need to be filed down as well in order to "cure" the fungal nails.

    I have not seen any research articles that compare PinPointe and conventional antifungal solutions (of course I expect that in both group the nails are filed down to the same level). arcom, do you think if you had had your nails fileds down and then treated with daily antifungal topical (without the laser treatment), would you have achieved the same result as the laser treatment? I think it's still possible.

    It's worth noting that you don't need to file down nails when using Fotona laser. This greatly reduces the occupational risk caused by fine particles from the fungal nails during debridement.
     
  22. arcom

    arcom Member

    The only topical method I found which provided some improvement was the suggested thinning of the nails and frequent trimming of the bad nail. I used a dremel as did another poster to thin the nail plus the daily use of a topical antifungal solution. The "mix" I finally settled on was a combination of over-the-counter tolnaftate, undecyclenic acid, and clotrinizole solotions. Probably makes some pros winch but it was easy to use and was non-irritating. What I noted was that after cutting back the dead nail, the solution improved the appearance of the skin formally under the nail. But the nail as it regrew would still be infected. Over the course of time the amount of clean nail that would grow back increased slightly. BUT it was literally years in accomplishing this. In my case, I ultimately had but six months. So the laser was my choice.

    Of course, like most other toenail fungus sufferers I became acutely aware of the toes on other people. I soon realized this affliction is much more widespread than one would think. My wife who has perfect nails thinks I'm being silly and perhaps too vain. Not me.

    Thanks.
     
    Last edited: Mar 7, 2011
  23. arcom

    arcom Member

    What are you using and will you continue the over the counter topical permanently?

    I use spray Tinactin

    Did you do anything to address your shoes, socks, and living environment after the treatment?

    For many years I've made it a point to wash me feet daily, use fresh socks and do my best to avoid places that might breed fungus.
     
  24. Frederick George

    Frederick George Active Member

    arcom, I'm a little suspicious that a patient would join Podiatry Arena just to declare what a success their particular treatment was. Who told you about Podiatry Arena?

    You weren't put up to this, were you?

    Cheers
     
  25. arcom

    arcom Member

    Frederick George--

    I can understand your suspicions regarding my motivation for posting, especially as a non-professional. But let me be very clear--I have absolutely no interest, financial or otherwise, in promoting laser treatments and my only claim that it is successful is in regards to me personally. I found the podiatry-arena in the course of doing google research for a co-worker whose podiatrist believed that laser treatment was as yet an unproven therapy.

    I apologize if my postings are out of the normal use of this site. This thread (and the site proper) was the only one I found where professionals discussed this therapy at length. I'm sure there are others but they may be out of bounds to the layman. Unless specifically asked a question, I will refrain from further postings. But I do appreciate the fact that the podiatry-arena is open to all to read and that is what I will do in the future.

    Thanks
     
  26. hamish dow

    hamish dow Active Member

    As ever there largely seems to be two factions: one that has a problem with the way another company has decided to set up its business plan without knowing or finding out what the company is trying to do or how it will fund itself in the future, and the other who are looking for a sustainable secondary business model. Perhaps it is only socialism vs capitalism, I obviously fall into the latter camp so that is where my part of that story ends, my choice.

    My appreciation to arcom posting. One has to largely take it on trust that people are being honest. It takes some courage to post in an arena that has a reputation for being a "bit of a bear pit"( not my words but those of someone who cast their eye over it). A salutory reminder that this is a forum with public access, reminding us that levels of courtesy and professionalism must be maintained, lest we be judged poorly. Fortunately for me several patients who have sought me out read the site and passed judgement in my favour.
    More information for you regarding questions to me:
    All patients laser are assessed as to the level of damage and infection they have I use a simple Hamish Dow sliding scale of 1 - 4, the latter being the worst with penetration through to the nail root matrix. If there is little thickening I would not necessarily reduce the nail back beore lase. I might split the lase before debridement and also after debridement, it would depend what I was looking at.
    As a personal observation: over the years here in the UK I have treated a great many infected nails, I personally have not seen debridement and topicals work on the heavily contaminated nails.
    I think it is incorrect thinking to believe it is this that is ridding the nails of infection. However debridement helps eradicate the build up of garbage, antifungals help prevent repeat colonisation of a sterilised area. Regular debridement post lase ie good after care helps the progression of newly recovering tissue progress along the nail bed.
    One last thought. Is it that much of the negative feeling on this is tied to the fact that this therapy is closely tied to the old clinical skillset that is part and parcel of what originally was chiropody and to some it is beneath them. A sort of podiatric snobbery, in the eyes of some it is not acedemic, non surgical, non biomechanic and falls below the radar of what they consider "meaningful".
    Having something that falls into the hands of a clinician working in the field of general practice somehow offends. The constant referencing of the cost is a smoke screen. The cost of diagnosis and orthotic pricing in some practices is eyewatering too yet requires far less time than the 4 hours that I allocate to my lase therapies.
    Time for me to be contentious and raise a question. Is FHL not merely a manifestation of posture and not a clinical problem. Has anyone else not noticed that it requires no orthotic to manage but an decent explanation of contra rotational gait and progressive loading rather than impact loading? how many people flog orthoics to correct FHL when non is actually needed?
    Might I suggest you just email me directly rather than wait for me to wander back into the arena?
     
  27. hamish dow

    hamish dow Active Member

    My apologies to all, the last post was not my finest post. Fatigue clouded my judgement, some content should be elsewhere. If the Administrator would like to rwmove it I am happy and I can then be more cogent in my response to what was asked of me.
     
  28. charlie01

    charlie01 Active Member

    Thanks for the info, hamish.
     
  29. Moose

    Moose Active Member

    Does anyone know the ball park financials involved in ending up with one of these units in a practice? Mostly just curious ....
     
  30. RiverRider

    RiverRider Member

    Bumping in hopes that more of the folks providing laser therapy with let us know what a complete treatment plan looks like.

     
  31. Here are some interesting thoughts on the new and expensive treatment products for onychomycosis from Dr. Warren Joseph from his Podiatry Today blog.

    http://www.podiatrytoday.com/blogge...-onychomycosis-product-‘80-percent-effective’

     
  32. hamish dow

    hamish dow Active Member

    Yes I had read that too.
    Who is possibly abel to tell me the general average hourly rates for podiatrists in the States? or what is considered to be the average wage? does that exclude perhaps the practice running costs? What does it cost to run a podiatry practice per annum in the States? I have asked before but somehow it never seemed to get answered.
    I am curious if there is some difference for those working off a purely private non health insurance practice and those working like our NHS colleagues over here.
    I dont quite know how our two countries differ in these respects. It did seem that when I have visited the USA so much was cheap compared to GB, petrol for starters. But then I also saw crushing poverty too side by side with remarkable wealth.
     
  33. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Kevin:

    Thank you for posting that. Warren is absolutely correct in his assertions.

    In addition, I have put together some information for readers to help them decide what are important review criteria for Journals reporting Human data.


    First: Please negotiate to the following SPIE Web site: This Journal is a physics journal that frequently has many "Laser" articles in it.

    SPIE Manuscript Policies and Review Information: http://spie.org/x14099.xml

    *There is not a single medical database where the SPIE Proceedings is indexed that I could find.

    *There seems to be no criteria for Human experimentation or Human data presentation that I could find
    .

    Is Human data and informatioin reported in a journal like this relevent?

    Sure, but my view (personal) is that Human studies that are published, must reach higher regulatory bars. Most medical journals feel the same way. For example:

    Please compare and contrast SPIE requirements to The Journal of the American Podiatric Medical Associations review policy for Human data: Link (also) below.

    Ethical Requirements.

    For studies involving human subjects, approval by an institutional review board is required and should be stated in the Materials and Methods section. For investigators who do not have formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. http://www.japmaonline.org/misc/ifora.shtml

    The Journal of the American Podiatric Medical Associations complies with all Human Experimentation laws and regulations, as does every other major Medical Journal I have ever read.


    Finally: please also see FDA Guidelines for "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices” http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm

    It appears that only when - “Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).”

    I have always taken the position, that testing any new medical device (product) for a new medical procedure (and publishing the data) is certainly beyond “the intent is the "practice of medicine"” clause, and requires a Human Investigational review board.

    This is one of the reasons medical publications require them. In my view, it is necessary that most (if not all) medical journals require IRB confirmation (at a minimum) before Human Data is published. This information is usually found in the materials and methods sections of articles.

    I Hope this also helps docs read and process data as they move forward with the best research for their patoents.

    Best regards,

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    Cell: 508-380-9866
     
  34. hamish dow

    hamish dow Active Member

    Yes, I am reminded of the phrase "the absence of evidence is not evidence of absence"
     
  35. A useful and true expression.

    The flip side expression being "that which is asserted without evidence can be dismissed without evidence".

    Whatever.

    I once had a presentation from a rep on his topical antifungal. He had the usual glossy "research summary" which showed his product had approximately double the efficacy of a competitors. On close (and it had to be VERY close because it was in the small print) examination, the competitor was being judged on negative culture and the product being sold was being measured on "% with an observable change".

    I forget the exact numbers but I read somewhere that 78.3% of statistics are made up on the spot (or was it 87.3?). I have a slide in one of my presentations wherein raw data is presented as 4 different percentages which are all true, but indicate vastly differing results. As Dr Joseph says, a number on its own means exactly squat.
     
  36. hamish dow

    hamish dow Active Member

    Fortunately I have the reuslts of a planimetry study of patients I have treated, and a decent back catalogue of images taken during the treatment cycle and the data from a multi-site retrospective study that was conducted in five private practices in the UK and the USA on 458 great toes from 265 sequential patients that I was involved with so I feel comfortble being able ot use my own experience.
    It helps me during my discussions with those people who choose to elect to use this approach to their problem. Fortunately patients have options for treatment which may actually be an alternative to this energy based intervention, I aim to force no one into the treatment. Most people who end up at my door asking for the treatment is because they have looked at what information is their and wish to try it.
    I suppose they are "self actualising" or demonstrate a reasonable level of self responsibility. Individuals respond to the action of the lase as individuals too, so it is never quite possible to make exact like for like comparrisons, but I can at least show examples of previous treatments that bear as close a resemblance to their conditon as is possible because I have photographic records of all treated pateints and their treatment pathway. It is so heartening to see those treatments that are jaw dropping, but it is more the norm for steady change over time. As it is a new modality for treatment there is no real like for like comparrison other than the treatment is in the moment and not a daily intervention and it is non toxic too.
     
  37. Ian Drakard

    Ian Drakard Active Member

  38. Frederick George

    Frederick George Active Member

    I must be missing something here. None of the photos on the Cutera website show clearance of the fungus. In some there is slight improvement, but others are no better. I would suppose that these are the exemplary cases.

    The question becomes not whether Nd/YAG laser treatment works or not, but how one convinces the patient to be satisfied with a poor result.

    Cheers
     
  39. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Frederick:

    You are not missing anything about Nd:YAG technology for Onychomycosis.

    I wish one of the companies that is pushing this technology would publish ANY peer-reviewed and IRB approved data to support their claims and pictures.The only published study with pictures is still the Noveon laser.

    http://www.podiatrytoday.com/emphasizing-importance-ebm-when-it-comes-laser-care-onychomycosis

    http://www.japmaonline.org/cgi/content/abstract/100/3/166

    http://onlinelibrary.wiley.com/doi/10.1111/j.1751-1097.2009.00615.x/abstract

    http://www.japmaonline.org/cgi/content/abstract/99/4/348

    Currently, we have signed a Canadian distributor that is beginning to take pre-orders ahead of out health canada application. We have made preliminary agreements witha European distributor, and we have had meetings with Australian distribution partners. We are still awaiting final FDA for our onychomycosis indication. Our two current FDA approvals are for Podiatry and Dermatology.

    For interested parties, Before and After pictures with the CE Marked Noveon laser can be found at:

    http://www.noveoninternational.com/consumer/before-and-after-clearer-nails-with-noveon-naillaser

    Best Regards:

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    www.noveoninternational.com
    Cell: 508-380-9866
     
  40. charlie01

    charlie01 Active Member

    "For interested parties, Before and After pictures with the CE Marked Noveon laser can be found at:

    http://www.noveoninternational.com/c...veon-naillaser"

    (1) The patients 3 and 8: it seems the nail growth is a bit faster then expected

    (2) I cann't see any big changes to the nails of Patients 6 and 7.

    (3) The colour of the Patient 2's nail seems to be a little bit worse than pre-treatment.
     
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