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  • Quote:

     
     
    1. Are you also using this same logical pathway when referring to the current custom foot orthotics that are being embraced with claims that they place feet in subtalar joint neutral, make patients walk or run better or change locomotion?, to name a few?
     
    Custom foot orthotics, according to the literature, do not reduce injury risk in or treat soft tissue injuries long term,
    they do not reduce hyperpronation and if they do, that does not seem to be how they work,
    they do not improve structure
    they do not improve function and performance,
    they do cause predictable, compensatory, collateral damage to the feet and posture long term suggesting negligence in their undisclaimed use.
     
     
     
     
     
    Disclaimers: I am the US Patent holder for foot centering orthotics and a consultant for ClearAnail and therefore, I have bias and profit motives in this discussion
     
    Dennis




    Dennis, 

    Your diversion from the topic of this thread had an error.  

    The Cochrane review does show some positive effects for orthoses.  There are conflicting studies, but your statement that "Custom foot orthotics, according to the literature, do not reduce injury risk in or treat soft tissue injuries long term," is incorrect.   

    http://www.cochrane.org/CD006801/MUSKEL_custom-made-foot-orthoses-for-the-treatment-of-foot-pain_

    Eric

  •  

    An open comparative study of nail drilling as adjunctive treatment for toenail onychomycosis

     A. Shemer, A. K. Gupta, B. Amichai, R. Farhi, R. Baran, C. R. Daniel III, D. Daigle & K. A. Foley (2016) An open comparative study of nail drilling as adjunctive treatment for toenail onychomycosis, Journal of Dermatological Treatment, 27:5, 480-483, DOI: 10.3109/09546634.2016.1151856

    Thank you, David, for recommending this Shemer article from Canada, published in March 2016.

    This work will satisfy Dr. Markinson's requirement, to a very large extent. Outcome measures include clinical and mycological cure criteria assessed at 4,10, 16, 22 and 28 weeks.

    There is a total of 98 participants.

    This is a three-arm trial, with three parallel study groups: trephine technique with combined oral and topical terbinafine, holes with topical terbinafine and lastly topical terbinafine only.

    Although not a Clearanail device, the authors used an alternative self-regulating trephine apperatus. The drill bit size of 1.8mm diameter presents a noteable difference, with the Clearanail providing true micropores of 0.4mm diameter. 

    The authors conclude: nail drilling as an addition to existing onychomycosis treatment regimens produced significantly greater improvement in nails’ appearance and numerically higher mycological cure rates compared to topical treatment alone, likely attributable to increased antifungal penetrance through the nail plate.

    This paper is furnished with numerous graphs and tables to provide further information that includes: Mean percent clear nails for visit 1-6, demographic data, mycological cure rates by visit 1-6. I can thoroughly recommend this excellent study, as good evidence for the addition of trephine technique in the definitive management of onychomycosis. 





  • Bryan:

    I will start a new thread regarding your treatment protocol(s) for plantar fascitis so as not to reduce the focus of this important thread.

     

    Dr. Markinson: seems likely you need to control foot pronation issues and would benefit from an evaluation for Hyprocure ;-)

  • Quote:

    To Dennis,

    I treat onychomycosis as an infection. Patients are told how they get the infection, and that laboratory confirmation is required to begin antifungal treatment. I know in that scenario, I will get 70-80 percent of the patients improved to varying degrees, including cleared.

    I am fortunate that I get tertiary referrals for onychomycosis where any number and types of treatments have failed. In more than half of those, no laboratory confrmation of the infection was obtained. This single point is in my mind the leading cause of frustation with treating onychomycosis, AND the major reason why many good treatments might get labeled as ineffective. ClearANail will not be immune to this, and not having a legitimate clnical trial gives license to anyone who uses the technology to do whatever they want with it, and puts the reputation of the technology at risk.

    Bryan:

    I will start a new thread regarding your treatment protocol(s) for plantar fascitis so as not to reduce the focus of this important thread.

    Back to onychodystrophy/mycosis:

    The goal of treating any infection should be a cure. Getting a wart 50% “cleared” is not an acceptable treatment goal, is it?

    In stating "I will get 70-80 percent of the patients improved to varying degrees, including cleared", I must ask if that is good enough if you are treating an infection.

    In my practice, on the initial visit I power drill ugly toenails and get 70-80 percent of the patients improved to varying degrees, including cleared”.

    Fungus, in these cases, is an opportunistic infecting microscopic plant that needs a compromised (or dead) host in order to colonize. In human toenails, that compromise stems from primary endogenous or exogenous underpinning factors.

    Immunosuppression, chemotherapy, tight shoes or underpinning biomechanical macro and microtrauma sit high on the list why fungal invasion of a toenail might be successful.  I consider strengthening and protection of the defense/barrier function of potential or existent host toenails to be an integral part of my treatment plan.

    Healthy, non-traumatized, well nourished and hydrated tissue will not be infected by saprophytes. IMHO, not diagnosing or treating unhealthy, traumatized, poorly nourished and over or under-hydrated toenails is the number one reason for the frustration that exists for us all when dealing with onychodystrophy.

    1. What is your clinical “cure-100% cleared” rate for this onychomycosis or onychodystrophy?

    2. Do you have consensus that neither of us has evidence to back up our expert opinions?

    Dennis

  • Dieter,

    I will do better If you e-mail me at davidzuckermandpm@gmail.com I will send it to you . Getting if from the journal will cost you $17 dolllars.. davidzuckermandpm@gmail.com
  • Quote:

     Dieter

     

    I agree  the treatment of  Fungus  toe nails is nt  a magic bullet..  Combination therapy  is perfect with the Clearanail drill.  As far  as  ethics as to what a  doctor will do with his patients.  is beyond this  post  I will make one comment I feel its the obligation  that  all doctors give all reasonable options  whether its a cash or  an insurance covered treatment. My experience is that  a hugh amount of podiatrist onely  present  the  insurance covered procedure without any option of the  cash procedure. These are my finding .  David

    Nobody said magic bullet. Dr. Thomas made the association with a silver bullet. As the innovator & designer of Clearanail, his exuberant enthusiasm can be excused. Clearanail is never used in isolation and will require a topical anti-fungal. It's always combination therapy. The basic concept is really a 'no-brainer'.

    The micropore trephined and suitably prepared nail plate will function as a super charged drug delivery system. We know, already, that modern anti-fungals are powerfully effective in-vitro. The barrier of the dense keratin nail plate is the in-vivo nemesis of all of the topicals. Clearanail effectively, and simply, eliminates the obstacle with an ingenious and unique instrumentation design and thoroughly cunning technology.   

  • Quote:

    The road blocks to research are generally surmounted with money from the company creating the device. Most major academic centers have industry partnerships just for that. But I do understand that it the manufacturers of Clearanail can sell 100 devices without research or double that with research (with good results) they may actually lose money when the cost of the research is factored in. I really hope we find that it offers a great, ground breaking alternative to onychomycosis treatment......but "I am telling you it works great" doesn't seem to impress anywhere but in podiatry.

    I am still not convinced this can help, in every office / clinical situation. A fee-paying patient will be attending the office looking for an effective cure and not to become part of a randomized study when a patient might be randomized to a potentially sub-optimal treatment they may have tried already.

    I have experience of research, when even in a socialized health-care system there are many confounding variables to complicate even the simplest of study designs. A study, such as this, sounds 'simple' enough, as a sound bite, but that is rarely the case.

    Dr. Markinson, you are ideally placed to conduct such a study. Perhaps Clearanail can make available the equipment 'on loan' for the purpose of such a study.



  •  In more than half of those, no laboratory confrmation of the infection was obtained. This single point is in my mind the leading cause of frustation with treating onychomycosis, AND the major reason why many good treatments might get labeled as ineffective. ClearANail will not be immune to this, and not having a legitimate clnical trial gives license to anyone who uses the technology to do whatever they want with it, and puts the reputation of the technology at risk. 

    This was discussed before, I believe. A unique advantage of the Clearanail system - the fact the nail debris is delivered from deep within the nail to provide an excellent specimen for analysis from multiple sites. Without (potentially) torturing a patient with an aggressive nail resection that might be required to get that representative sample of nail. 

    I thought I would chip in, with this useful information, since the Consultant and Foot Docpreuners have not done so. As an aside, no 'mentoring' is required for this simple and effective procedure. 



  • Quote:

    Dieter 

     

      Have  you read the three arm study by Gupta.  Its  not only quality  its a quality dermatology ... Journal of Dermatology  Treatment   Its a very good study with a top  dermatologist  Dr. Gutpa  

    David,

    A detailed reference for this paper will be more helpful. If you can, please add to this list:

    Gupta, A., et al., Prevalence and epidemiology of toenail onychomycosis in diabetic subjects: a multicentre survey. Brit J Dermatol, 1998. 139: p. 665-671.

    Gupta, A.K., J. Ryder, and A.M. Johnson, Cumulative meta-analysis of systemic antifungal agents for  the treatment of onychomycosis. Brit J Dermatol, 2004. 150: p. 537-544.



  • Dieter 

     

      Have  you read the three arm study by Gupta.  Its  not only quality  its a quality dermatology ... Journal of Dermatology  Treatment   Its a very good study with a top  dermatologist  Dr. Gutpa  

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