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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.
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 by arcom : 7th March 2011 at 08:13 AM.
Reason: speling
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?
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.
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?
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.
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.
Bumping in hopes that more of the folks providing laser therapy with let us know what a complete treatment plan looks like.
Quote:
Originally Posted by RiverRider
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?
Have You Heard About The Latest Onychomycosis Product That Is ‘80 Percent Effective’?
I was recently quoted in a very fair and balanced article on laser treatment of onychomycosis that was published in the Wall Street Journal and written by the newspaper’s Science Reporter Laura Johannes.1 During my interview with Ms. Johannes, I bemoaned the lack of published evidence not only for laser therapy of onychomycosis but for any of the recently promoted treatments, either device or solution.
I questioned the ubiquity of the claims of 70 to 80 percent efficacy that seem to be rampant. I asked her as I now ask you: What does it mean to you if I say a product is “80 percent effective”?
Think about that. Does it mean that 80 percent of the treated toenails became 100 percent cured? Does it mean that 80 percent of patients treated were satisfied? Does it mean that 80 percent of toenails reach some undefined clinical endpoint? None of this is ever spelled out.
Right in the Wall Street Journal article, Anas Khoury, DPM, notes that he has been using the Nomir Medical laser for four months. According to the article, Dr. Khoury says “it works in about 80% of his patients.”1
Ms. Johannes also notes how PinPointe USA supplied the Wall Street Journal with a summary of unpublished (my emphasis) data, claiming “71.4% of patients experienced continuous improvement over a year … .”
Let me share with you some claims right from onychomycosis promotions I have seen recently.
In a “testimonial” (the HIGHEST level of medical evidence, I am sure) on a Formula 3 topical solution brochure, a podiatrist from Nebraska states, “I would estimate (an) 80-90% success rate.”
In an advertisement for Fungasil solution seen in a doctor’s office recently, it claims, “50-80% cure rate within one year.”
Speaking to a sales representative at the Cool Touch Laser booth during the recent Desert Foot Conference, she noted, “The efficacy is 79.8%.”
From a direct mailing of a local podiatrist using laser therapy: “88% Effective, Proven Clinical Results.”
If I read a paper of a randomized, controlled clinical trial on an antibiotic therapy and there is a result showing 90 percent success, the endpoint is clearly spelled out. It may have been a 90 percent microbiologic cure (defined as negative culture) or a 90 percent clinical cure (no residual clinical evidence of infection), etc.
Even in the onychomycosis literature, when proper studies were performed on terbinafine, itraconazole or ciclopirox lacquer, you could read the studies and KNOW exactly what the endpoint was, be it mycologic cure, complete cure or something in between.
This is what is lacking in many of these claims. I find it hard to believe they all can be so incredibly close in efficacy and, frankly, how they can be … so effective!
I think we will all agree that the “gold standard” in the treatment of onychomycosis is oral terbinafine, followed closely by oral itraconazole. Yet, if you actually look at the FDA approved clinical cure numbers (clearly defined in the criteria as mycologic cure plus 100 percent normal nail appearance at the end of the study), terbinafine only had a 38 percent cure rate and itraconazole had only a 14 percent cure rate.2,3 Has medical science advanced so rapidly in the past 10 to 15 years that we can now double that success rate?
So why is a number between 70 to 80 percent used as a claimed efficacy rate for all of these various promotions against onychomycosis? I guess some may be based in clinical trials, published or not. Some of these efficacies may be absolutely true. I just do not know since, other than the published Nomir Medical study, I have not seen any data.4 This was my point in the Wall Street Journal article. Maybe docs and companies feel they need to claim 70 to 80 percent efficacy to feel comfortable selling a treatment or a product to a patient.
I welcome your thoughts and comments.
References
1. Johannes L. Fungus got your toes? Zap it. Wall Street Journal. February 22, 2011. Available at http://online.wsj.com/article/SB1000...15835163007632... . Accessed March 4, 2011.
2. Terbinafine package insert.
3. Itraconazole package insert.
4. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. 2010;100(3):166-77.
Editor’s note: This blog was originally published at www.leinfections.com/category/onychomycosis/ and has been adapted with permission from Warren Joseph, DPM, FIDSA, and Data Trace Publishing Company. For more information about the Handbook of Lower Extremity Infections, visit www.leinfections.com/ .
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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.
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.
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
Yes, I am reminded of the phrase "the absence of evidence is not evidence of absence"
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.
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.
The Following User Says Thank You to hamish dow For This Useful Post:
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.
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.
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:
One DPM says:"As far as mycology is concerned, after 27 years in practice, my diagnostic acumen is as good as the most common diagnostic tests which report many false negative results. If it's yellow and it smells it's most likely mycotic and I don't need to spend insurance dollars to confirm that. "
I have a question here:
Does every fungal nail (including toenails and fingernails) smell?
The main reason that "most" of them smell, is because of the release of volitile Sulfer compounds from the Nail Keratin, as it is digested by the Keratinase produced by the fungus.
Keratinases mainly attack the disulfide (-S-S-) bond of the keratin substrate that makes up 98% of the nail .
Keratinolytic protein from keratinophilic fungi has been reported by Asahi et al. (1985).
Asahi M, et al Purification and characterization of major extracellular proteinases from Trichophyton rubrum. Biochem J. 1985 Nov 15;232(1):139-44.
One of the first symptoms to disappear after Noveon therapy has been reported to be the "smell" of the nail. This is because the Keratinase enzyme production ceases when the fungus are killed.
However do we use our nose to confirm the diagnosis or we should do proper test before starting laser treatment? It's not cheap to have the treatment.
I believe firmly that you should get a positive laboratory result for fungus, whether it be (a) culture, (b) KOH, or (c) PAS before starting a patient on any therapy for onychomycosis.
There are a lot of psoriatic and/or dystrophic nails that could be treated with ZERO efficacy with any laser, as the fungus is not causing the problem.
If one lab test is negative and you really suspect fungal involvement, try a different test.
Press Release: GenesisPlus Receives FDA Clearance for Onychomycosis
Quote:
BRISBANE, CA- April 7, 2011-- Cutera, Inc. (NASDAQ: CUTR), a leading worldwide provider of laser and light-based aesthetic systems for practitioners worldwide, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its GenesisPlus. The complete list of the indications for use can be found in the FDA 510(k) clearance number (K) 103626.
Known medically as onychomycosis, nail fungus often causes the toenails to become discolored, thickened and separated from the nail bed. Approximately half of the population will have at least one infected toenail during the course of their lives. Current treatment options include prescription topicals and oral drugs, both with limited success rates. Some patients are not candidates for oral medications, due to concerns of liver damage and other treatment limitations.
"The GenesisPlus laser is a great innovation in the treatment of fungal nails and it has exceeded my expectations for safety and efficacy," said David Weiss, Doctor of Podiatric Medicine in private practice in Hammonton, NJ. "The options I've had in the past were limited because they didn't work very well and patients were concerned about side effects."
GenesisPlus utilizes Cutera's patented microsecond technology and features a proprietary delivery system with a temperature sensor to improve the practitioner and patient experience. "What impresses me about the GenesisPlus is the safety, effectiveness and speed of the treatments. In one 10-15 minute session, I can treat a patient who has been suffering for years with unsightly, deformed and discolored toenails," said Jeffrey Kleis, Doctor of Podiatric Medicine in private practice in Beverly Hills, CA. "There is no downtime and my patients have been extremely pleased."
Kevin Connors, President and CEO of Cutera said, "A significant number of affected patients are dissatisfied with the current treatment options, including topical therapies and oral medications. The GenesisPlus provides a fast and effective solution for onychomycosis, without the risks of serious side effects."
I wanted to further bring the Podiatric community up to date on current laser studies approaching the Onychomycosis disease paradigm.
Here is a very nice modern in vitro study (2008) describing pulsed laser effects on T. rubrum in vitro.
Vural E. et al. The effects of laser irradiation on trichophyton rubrum growth. Lasers Med Sci 2008 Oct;23(4):349-53
Abstract:
The effects of various laser wavelengths and fluences on the fungal isolate, Trichophyton rubrum, were examined in vitro. Standard-size isolates of T. rubrum were irradiated by using various laser systems. Colony areas were compared for growth inhibition on days 1, 3, and 6 after laser irradiation. Statistically significant growth inhibition of T. rubrum was detected in colonies treated with the 1,064-nm Q-switched Nd:YAG laser at 4 and 8 J/cm(2) and 532-nm Q-switched Nd:YAG laser at 8 J/cm(2). Q-switched Nd:YAG laser at 532- and 1,064-nm wavelengths produced significant inhibitory effect upon the fungal isolate T. rubrum in this in vitro study. However, more in vitro and in vivo studies are necessary to investigate if lasers would have a potential use in the treatment of fungal infections of skin and its adnexa.
These are the wavelengths, and fluences used during the initial phase of the study
In this well done study in vitro study, the Q-switched 532 nm light (visible green), in the Nd:YAG family, was superior to all other systems in T. rubrum inhibition. This Q-switched system pulses in nano-seconds, A nanosecond (ns) is one billionth of a second (10-9 s).
The only problem is, that 532 nm also has less than half the penetration value through the nail (i.e. to the bed and matrix) of near-infrared wavelengths, because of a very high protein absorption coefficient in the keratin.
The study authors concluded with this statement:
“In addition to more in vitro studies, in-vivo studies are necessary to investigate the possible therapeutic effects of various laser systems on various dermatopathogens, as laser–fungus interaction might be different when these microorganisms are embedded within the skin and its adnexa.”
Very nice science.
Eric Bornstein
Chief Science officer
Nomir Medical Technologies
Hi, Eric,
I just read the article again. I noted that the nails treated with 4J/cm2 1064nm laser produced less and smaller colonies than the nails treated with 8J/cm2.
I thought it should have been the other way round. Do you have any idea as to how it happened?
Two different lasers from Cool Touch have been used. One is Onycholase TM and the other is Cool Breeze. I watched a few video clips on Youtube and noted a podiatrist also uses green laser beam of Onycholase to treat nail fungus. http://www.youtube.com/watch?v=7FlLKiDbhcw
I thought green laser (532nm) won't work well due to poor penetration ability.
The authors of The effects of laser irradiation on trichophyton rubrum growth did reported that 532nm laser inhibited the growth of T. rubrum better than 1064nm.
Re: Laser treatment for nail fungus
Linear Mode
