Podiatry Arena members do not see these ads

I wouldn't call the podiatrists that are charging $800.00 - $900.00 (US) for this procedure, which involves about 10 minutes of the podiatrist's time for the procedure, as being "bold". Rather it seems rather strange to me how a podiatrist could advertise in local newspapers and magazines that their laser "cures toenail fungus" and charge that type of money to a patient [no insurances are covering this procedure] and tell them that they will cure their fungus infection when there is absolutely no scientific evidence of the following:

1. That PinPointe laser provides mycological cures to all treated toenails in a majority of cases.

2. That PinPointe laser prevents recurrence of fungal infection of nails within six months to one year following treatment.

Hamish, do you think it is ethical to perform this expensive of a procedure on a patient knowing full well that 6 months to one year after the procedure that their toenails could again be infected with fungus and need to have another treatment, again for $800.00 - $900.00 cash?

Unlike some podiatrists, my conscious couldn't allow me to take that kind of hard-earned money from people that have placed their trust in me as a physician for a treatment that has so little medical evidence that it has any long term effectiveness at curing onychomycosis.

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

Kevin ... you need to be careful what you say! Remeber that Rothbart fan that emailed us? I got a similar email from the PinPointe Company! I have added it to all the others in my trophy cabinet! (I will need a bigger one soon).

I am with you. Show me the data and not the hype or the markatroid sales pitch.

I see the Podiatry Today poll now has 218 votes, with 61% saying no to the question: "In your opinion, can laser care be a viable option for treating onychomycosis?"

__________________
Craig Payne
__________________________________________________ ___________________________________
Follow me on Twitter | Run Junkie
God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.

Craig:

Since when should we be worried about telling the truth?

If PinPointe really does have the peer-reviewed research (and which was not funded by PinPointe) to refute my claims, then let them present it here on Podiatry Arena and I will happily retract my statements. If they want equal billing, have them bring their head researcher on here to tell us how good PinPointe really is in curing toenail fungus.

In the mean time (and I won't hold my breath), I have enough patients here in Sacramento who have called locally about this "fungal toenail cure" procedure and have told me some very interesting stories about this whole process. My guess is that once the word starts to get around on the internet that this treatment really doesn't cure all forms of onychomycosis and that repeated expensive, cash-only treatments are necessary to keep it from coming back, that some of the "laser-luster" will be removed from the eyes of the public regarding this laser "fungal toenail cure".

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

Gentlemen,
Interesting responses.
One notion that I find at odds with the actual procedure (by the way do you know first hand what the procedure is in totality?) it takes me @ 40-45 minutes to administer the dosage across all nails not about ten minutes. It can also take me about 20 -30 minutes to debride the nails to the degree that I feel is right prior to treatment. I require time to take photo’s, administration, medical history and two follow up assessments with repeat photographic events. 10 minutes? I think that is so far off the mark. I forgot, I take time to actually talk to my patients and inform them of whatever they need to know too. 10 minutes? In the words of John McEnroe, “you cannot be serious?”

The patients I am seeing either do not want tot take the serious oral medications, or can’t because of the affects they experience (loss of taste for one was too much to bear and another thought blinding headaches and vomiting a little too much) or are just exercising their own personal choice for ease of treatment. I personally explain their options for treatment and they choose.
I take time to explain it as a treatment, and no I don’t offer a guarantee; I think no one would offer their patients a guarantee for most things if they are honest, even with a simple antibiotic one would not guarantee it is going to work.

However it seems that it is not unusual for people to want to try something when all else seems to be failing. I wonder about the ethics of suggesting a patient try a paint, lacquer or cream when one knows that it is about 90% certain to fail. Yet a great many do.

I think that one ought to describe the possibility of recurrence as a real prospect but unlike you I am less skeptical. Time will tell as you say.

It has attracted a fair amount of interest and reading has this thread with a small number of different individuals posting. I declare my own vested interest from the start. I have met the principals involved I am inclined to accept what people like Professor Harris has to say on the subject and will bow to his greater knowledge on what lasers are doing.

I think it is a great idea to bring on “their head researcher”. Obviously you did invite them after you framed your “trophy” and responded to the letter? Though I hope you were more diplomatic and used either their title or name. When was it you invited them onto the forum exactly? Mind you perhaps it might be wise not to suggest they provide you with their SAT scores, then again I am sure he has a highly developed sense of humour. I assume you will be printing your own some time soon too. They never did it when I was a child and if they had mine would probably be very disappointing.

But I have to say you are a curious couple of fellows. You debunk the company and the science because you say there is a lack of evidence, but you supply no counter evidence and data just opinion. I can see no indication of anyone’s qualifications in laser technology or laser medical research. I know I have non. But I am prepared to accept Prof. Harris as having the credentials he claims to. I take it on trust, just as I do on this site because I have never actually met the people here but assume that you are the people you claim to be and have your credentials as you say you do.
You refer to your “guessing “ it wont work.
You print data of lay opinion as if it were meaningful. Which is a bit like saying nine out of ten cat owners said that their cat preferred….. or, 6 out o8 eight women we asked thought that the product reduced the appearance off……
And then also present the opinion of patients (now we all know that they are seriously prone to misrepresentation particularly with authority figures or am I the only one with this experience in the profession?) who told some interesting stories, as if it were irrefutable fact. Now, to be fair, you have to disclose these stories in their entirety and establish the veracity and the credibility because you expect the same courtesy in return, and it would amount only to heresay
Regards Hamish

Hamish:

Ciclopirox (Penlac) topic nail lacquer works in about 60% of cases in my experience, has no side effects, costs only about $25/bottle, and will treat two hallux nails for about 2 months. Most hallux nails require 9-12 months of treatment so total cost to patient is $150.00 for a year of treatment, unless they have insurance coverage, which many do. In addition, ciclopirox nail lacquer actually has had multiple scientific studies on its therapeutic effectiveness.

Please provide us with a list of published research in peer-reviewed journals which show that PinPointe laser cures fungal toenails, as you say it does. In addition, please provide research that states PinPointe laser will prevent recurrence of onychomycosis or, if cure does occur, how long the cure lasts.

From http://www.drugs.com/pro/ciclopirox-nail-lacquer.html

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

Thanks for that Kevin,
Ciclopirox is something i have not had any experience with in the UK. Nor have I heard of it being commonly prescribed over here.

I must have misrepresented myself at some point so I appologise for that, but I am not a PR man for the company, a private practitioner only. I take it no one has invited the company to comment on the forum then?

I apologise again if I made claims that it cured the condition. Obviously you have my copy close to hand so can you just remind me where I said it? just cut and paste it, that will be fine.

I take it that the fact that a former President of the Sacramento Valley Podiatric Medical Society, and a member of the California Podiatric Medical Association and the American Podiatric Medical Association (who has been an off-site clinician in the training of University of California at Davis family practice physicians) operates a number of these devices in your immediate area must be a real bone of contention. The company based just up the road in Chico probably is an annoyance that they will not communicate with you, poor show seeing as they are as close to you as they are. Especially more so when that fellow is on Scripps drive too.
I will make a request to the company to see if they can be of any help. I was going to say more help but they might be in the dark about all this if no one invited them to be part of this discussion.
So perhaps a little more patience is all that is needed.
Hamish

Hamish You said that you take photos of your patients nails

Do you have documented before, after, after 6 months after 12 months etc which you can post to see the nail regrowth that have only had laser tx ?

Also in your practice how many patients do not have +ve results that have contacted you?

__________________
Mike Weber.



Crazy Mary

The sequence is for me is photo at presentation, post debridement (that needs to be both extensive and aesthetic as one can be) then again at 4 months, 8 months, as part of the inclusive elements of the treatment cost, and @ a year if the patient elects to. Patients make their own choices.

But it is still new here so the clinical imagery is not available. The protocols are still able to be moified to gain improvement as time moves on.
These are still the early days of laser treatment. So I do understand some of the thinking of the detractors, but I place myself in the other camp and find the whole thing iMmensely exciting because of the other obvious implications for us as a profession being offered the technology.

We are the 3rd clinic in the country to invest in the technology and I think there are (possibly) only two in mainland Europe. Lasers are used in air purification and decontamination and in the food industry to erradicate mould, bacteria, viruses and fungus. sympathetic resaeach has been going on for years. This is a modification and crossover application. The dental research that Dr. Harris has been involved with is quite "interesting" too.
Hamish

I am not sure what happened to my last posing I assume one of two things:
a. I was immoderate in my reply and it was censured
b. I did not send it properly and the Gods of cyberspace now have it
In the event of (a) I will rephrase.

I still think there is a slightly condescending and personal tinge to what is being said to me but accept I might just be sensitive.
But for all those others who are following this chain with various levels of interest I will say the following:
There are @192 doctors in America now using this device.
@13000 plus patients in a 12 month cycle are choosing to try the TREATMENT.

I went to a lovely town in America called Sacramento to be trained in the simple protocol and operating procedure for the device, and was deemed competent to use it.
The doctor who instructed me was Dr. Michael Uro, who has performed over 800 of these procedures in the last year.
Dr. Uro is a doctor of Podiatric Medicine in the Sacramento area working there for over 30 years and he has served as Podiatry Chair of the surgery departments of both Mercy General Hospital and Sutter General Hospital. Not only that he has served as President of the Sacramento Valley Podiatric Medical Society, and is still an active member in the Society. He is a member of the California Podiatric Medical Association and the American Podiatric Medical Association, and has been an off-site clinician in the training of University of California at Davis family practice physicians.
So I think I was instructed by a competent professional.

In the pursuit of the efficacy of the treatment and to review success/failure and documented photographic evidence he would be ideal to talk to. He is close to Kevin on Scripps Drive I guess about ½ a mile or so. Would it not be reasonable to have spoken /visited with him?
I also return to Dr. Harris and his reputation, I do not think he needs to be maligned. He does not sell PinPointe lasers. Plenty of scientists do however have stakes in what they develop, that in itself is quite normal, I have no personal knowledge of his financial situation.

What I do know is that there is plenty of science behind the science, and that has plenty of peer review. So some of the confidence in the procedure is born out of that.
Again, I suggest that anyone who is curious, shall we say, about what it is capable of might like to go and get it from the horse’s mouth. It is not hard to contact Dr. Harris directly; even pit your own extensive knowledge of laser capabilities against his. Then post here why he is wrong.
If this is so wrong why have the Professional Podiatric bodies not censured the 190 or so doctors using it?
Finally, my very first patient was a solicitor who had been taking prescribed oral medication for over a year to no effect. He accepted the odds on the treatment that I explained to him and he chose treatment with the laser. So I think I have behaved professionally.
Ultimately I accept that I stand at odds with some individuals and we will have to agree to disagree on what it actually does. I suggest people need to talk to the scientists involved if one does not trust the company involved. But asking each other about it and offering unqualified opinion is fruitless. Probably even mine.

It wasn't that!

__________________
Forum Rules | FAQ's

Hamish - the reason for the reactions that this product/technique is purely to do with the way it is being promoted. And after seeing the pattern so many times before, the cynicism comes in.

It is a new piece of equipment, that is expensive to provide the treatment.

Those touting it on YouTube and other places it claim FDA approval (when its not approved for onychomycosis).

Those touting it claim remarkable success rates, yet as its a new piece of equipment none of them would have owned the device long enough to see these results.

There is a small uncontrolled study from the company that makes some remarkable claims - but it appears to be uncontrolled and its unplublished, so we not going to accept that blindly.

The pattern of the way it is being marketed, we have seen many times in the past. We been there done that. Guess what happen to the other techniques that followed this pattern?

Can you understand why the skepticism? There is huge interest in this topic (its already made it on to the most viewed list)

There is what appears to be a reasonable clinical trial underway, but it is funded by the company, (PinPointe / Patholase) so does lack a certain amount of independence (link to trial). Why is it being marketed and adopted without the data from this study. We will eagerly wait to see if the study gets published (its scheduled for completion in August 2010).

As always, I will always be the first to go where the evidence takes me. I will be urging the University to get one if the data supports its use.

__________________
Craig Payne
__________________________________________________ ___________________________________
Follow me on Twitter | Run Junkie
God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.

Craig,
Your last posting was more the standard of reply I was expecting when I first stepped in.
I do understand the skepticism and am adept at cynicism.
You put your thoughts this time in a well drafted form, that one post says it all about the reservations many have. It is cogent and the best written piece of counter point.
One College of Podiatry in the Sates has one for trials already so I was led to believe, quite what the project is I am unaware. So I am sure they would be very satisfied if your educational establishment were interested in due time.

Hamish

What fun!

I had'nt checked this thread, not being dermatologically minded. I've missed out!

I struggle to follow the in depth science of lasers. How a laser can pass through opaque tissue or attack pathogens whilst leaving healthy cells undamaged is a closed book to me and not one I have a particular interest in opening. I suspect few who talk of wavelengths, growth factors etc actually know what these things mean.

What I DO know a little about is outcome measures and cognitive psychology.

So, Hamish. In an honest and open handed attempt to elevate this thread back to the matter in hand I have a simple question.

You said

Fair enough. You can't show us positive or negative outcomes where you've not been doing it long enough for the TX to have worked. All new treatments must go through this period of uncertainty. So from this I can infer that you've as yet had insufficient numbers through to provide positive case studies yourself.

I can also infer, through its absence here, that there is no controlled trial.

My question then, and please take it in the spirit in which it is asked, ie sincerely, is this.

Why do you beleive this treatment is effective.

What made you sufficiently sure that this treatment worked to make the substantial cash outlay?

Regards

__________________
Robert Isaacs
Specialist in Biomechanical Therapies
www.Footprintspodiatrysolutions.co.uk

small, yellow, leech-like, and probably the oddest thing in the universe

Semper in excretum sum sed alta variat

Robert,
in the spirit of sincerity in which you ask, and replying honestly in the same manner to someone who is knowledgeable in cognitive matters, you already know my answer.

I chose to.
We always choose, whether we do so actively or passively, consciously or unconsciuosly.

So it is largely irrelevant to anyone but me. But thank you far asking, beyond that I have nothing more to say.
The bigger question would be why did I choose to bother and persist? but the answer is the same I chose to.

I will have to reflect on that to consider the value of the exercise to me and to absorb what has been revealed to me during the exchange. I am sure it is most enriching.
I have contributed my part and it is now at an end.

Your stock just went up a few points hamish. That's a good answer. You are more honest with yourself than most.

You say you're done here but I'll continue anyway.

The next question is why did you decide to? There are always reasons although they are rarely the ones we think they are.

Was it because it's nice to have a solution when others don't? Hope is a powerful motivator. That certainly predisposed me to believe in dry needling (at least enough to try it)!

The reason this is a relevant line of enquiry is that presuming we start from a baseline of unbeleif there must be something to convince. And whatever made you believe may also convince others... But only if you can identify it.

The mistake that many who bring their new ideas to the arena make is to think that their belief will make others believe. Usually we are inclined to belief, then we seek evidence and rationale to support it.

So my advice to anyone in that situation is to carefully examine why they chose to believe what they do. This required a significant degree of self examination and more honesty than most people can apply to themselves.

Regards

__________________
Robert Isaacs
Specialist in Biomechanical Therapies
www.Footprintspodiatrysolutions.co.uk

small, yellow, leech-like, and probably the oddest thing in the universe

Semper in excretum sum sed alta variat

Hamish,

I agree, that was a candid reply. Funny, I was just musing over the psychology/similarity of your choosing to "believe this treatment is effective" to the choice that many of us have made in trying Falknor`s needling technique, since observing the great pictures on this forum (although there does not appear to be any robust, repeatable evidenced based research carried out), when Robert piped up!

Let`s hope the Multi-Center Trial by Patholase produces some meaningful data, I will be watching with interest.

Cheers,
Bel

__________________
Just a rock `n roll refugee.

If...

It is perhaps more honest of me to say I am done with my rehashing of that which has been done.
This is curious though, is this a philosophy thread now?. That anyone would be interested in my internal processing mechanism. I am not sure we are in the right forum but until we are invited to take it elsewhere I will see what I can do to help you a little.

I have lost the point of why did I decide to? Decide to what Robert? I am genuinely not sure what you mean specifically.
Your wish to offer hope, no doubt with integrity of belief is in my book laudable. What else do we do what we do, if not to offer help in ways we believe we can?

Like the Dow Jones I am sure my stock, as you put it, went up with some and down with others, it is of little consequence really.

The presupposition of starting from a state of unbelief may effect all thought that flows from it. As to would starting from a point of openness, trust, honesty and positivity. This does not constitute absolute acceptance, and being a doormat. Far from it, but it puts oneself in a good state for confidence to survive and possibly one might be more likely to leave the world a better place than it was we arrived in it. If one can leave a legacy when one goes perhaps this is an honourable one. Is this what you wanted to know of me? My convictions?
It is not my intention to sway anyone to my life style or beliefs I am just answering what I thought was being asked of me. So please accept it as such.

As for convincing others with my beliefs so that they might believe too? It is not my place, I must respect they have their own thinking processes to negotiate. Robert Diltz, Vaginia Satir, Fritz Pearls, Milton Ericson and probably even Bandler and Grinder could better explain how we form our beliefs and maintain them better than I could anyway.

What I recognized with my belief system was congruity in the communication with those I met and spoke to. In my dealings with them I continue to find them helpful, open and quite willing to answer questions. If they are unable, as would be expected with scientific issues, they willingly go to source or will put anyone in touch with the reputable scientists involved.

I have no real interest in seeking approval on this site nor do I wish to insult. What I thought, and still see in what I wrote, was a fresh view and it was contrary to some thought but it held information that was missing.
I can offer the following as information, what one does with it depends entirely what is in the reader’s heart, and possibly if they are in a good place or not:

The further study being conducted is not a short-term thing. One of the studies being done in Canada is a five-year study that will include many different treatment variations from one treatment to many over a period of a year, looking for the best efficacy by treatment regimen.

They believe it is their duty, knowing that the laser works as intended to be sure that the protocols followed are the best possible in every possible case.
Remember this is their view. If specific questions require answering they will be the best ones to supply an answer. No one hear will actually be able to answer it in all probability. Not me, I can be a conduit but what is the point of having a telephone and computer if one does not use it to help get answers from where the best source is. I read the promotional information then started speaking to them.
I understand more about light now than I did before but only to a point. I had forgotten about it being merely a component of the entire electromagnetic spectrum for a start. No doubt to some a shocking admission.

Yes they are funding the study just as major drug manufacturers do but, they have no say in the outcomes. It is my understanding that when a drug manufacturer needs a new drug tested, they hire the companies to test them. This is also done in a manner where the company has no say in the proceedings as to how the tests are conducted etc and they have no say on the final outcome.

They would be rather foolish to submit to this kind of testing if they had any doubt that the end result would not be advantageous to them, their business plan, partners and most of all, the patients.

As for the laser that is in New York at the Podiatric College, I understand the following to be true; it is being used to treat inner city people (Harlem) who would otherwise not be able to afford treatment. The deal made with the college was that they could use the donated machine to treat the poor, as long as they kept careful records of every procedure so that we could use results later and so that the up and coming new generation of podiatric professional would understand and use this new modality.
I suggest that this would need verification to some and I suggest they find it for themselves.

To finish, this has been out there to be found by anyone who cares to look since February of this year, and it is permissible to use it in its entirety. Again remember this is what someone else wrote and I would suggest if anyone has issue with it contact the individual directly firs as it would be the most grown up thing to do

“02/25/2009 John Strisower

WI Podiatrist Among First to Use PinPointe FootLaser

I would first like to take this opportunity to 
say thanks to Barry Block and PM News for 
providing this very efficient communication 
channel for our industry. I have been in 
numerous industries in my career and I can say 
as a matter of fact that this is one of the best 
there is.

There are and have been many misquotes in the 
press and I cannot speak to whether or not Chris 
Milkie, DPM, was misquoted as stating “88% cure 
rate” or not. Our first clinical trial showed 
88% of patients improved with a single treatment 
followed for 6 months. The results of that trial 
have now been published and is available by e-mailing me at: John@patholase.com

We have never claimed that this device and 
procedure provides a “cure.” The PinPointe 
FootLaser is a safe and effective way to treat 
onychomycosis and its use results in clear nail 
growth for patients in most cases. It has to be 
used correctly and consistently to achieve best 
results. Most patients will see a noticeable 
improvement with a single or small number of 
treatments. All providers and patients should 
have the expectation that one or a small number 
of procedures will be required to achieve best 
clear nail growth. Obviously, as with any 
medical device, the provider will exercise their 
best medical discretion and obtain patient 
consent to the procedure and cost in advance of 
service provision.

Our clinical data is still being developed and 
it is early. We have formally studied a small 
patient population, though those familiar with 
statistical power analysis will appreciate that 
a small patient population (n-value) is needed 
where the efficacy is very high. Where the 
efficacy is very low (i.e. treated not very 
distinguishable from untreated) a large n is 
required. Most drug studies require very large n 
numbers because their effects are low and due to 
their systemic nature require a large n to 
demonstrate safety.

Our power analysis showed that 19 subjects was 
far more than adequate to demonstrate a p-value 
< 0.0001 which is incredibly small, meaning that 
the effect caused by the FootLaser procedure had 
very high efficacy. One letter to PM News 
stated that our research showed no 
discrimination between treatment and no 
treatment for culture results and notch 
measurement which is true. Our culture results 
were very mixed (as are all culture results 
published in all studies done before us). This 
demonstrates why we are using new analytical 
techniques in our new trial, we will set a new 
trial standard. The notch measurement was nearly 
equal in treated vs. untreated which 
demonstrates no significant change to the nail 
growth between treated and untreated which is a 
critical safety measure.

This is the first published study. We are now 
embarking upon a very ambitious multi-site, 100+ 
patient, long-term follow-up study to 
unequivocally demonstrate the safety and 
efficacy of this revolutionary new technology. 
The sites involved each have specific expertise 
and offer unparalleled quality in clinical 
research and respected publication. Two sites 
have principal investigators who are very well 
respected and published dermatologists with long 
term clinical study expertise. Another site’s 
principal investigator is a world renowned 
general surgeon who has developed published 
expertise in clinical trials in photomedicine. 
Our final site principal investigator is one of 
the most prolific onychomycosis clinical trial 
podiatrists.

This new clinical trial is about to begin 
recruiting patients across the country and 
internationally (one site is in Canada). The 
level of scientific rigor and methods of 
analysis embodied in this trial will set the bar 
for future Onychomycosis trials.

The PinPointe FootLaser in addition to being 
cleared by the FDA, has the first and only 
European equivalent medical device clearance for 
the safe and effective treatment of 
Onychomycosis (CE Mark) based upon the same 
published study attached. Despite the solid 
science upon which everything PinPointe (and its 
parent company PathoLase, Inc.) base its 
business decisions, we are all looking for and 
requiring a higher level of evidence and quality 
of clinical trial data.

Given the state of current evidence available to 
providers, the PinPointe FootLaser is only 
appropriate for those that are visionary 
leaders in the podiatric community. We fully 
expect that providers who are interested and 
become involved today are those that understand 
where the science and data are and where it is 
going. They are the visionary pioneers of the 
industry that are taking advantage of 
technological developments to propel their 
practices to new heights while leading the 
industry.

We are planning long-term on having only the top 
10% of podiatric practices as contracted 
providers. In the near-term we are limiting this 
number much further and are already close to 
closing out numerous major metro markets for 
2009. With better than 50 providers in 18 
states, we are seeing a groundswell of provider 
feedback for those that have been practicing 
this procedure long enough. As you all know, it 
takes a few months for even a small distal 
lesion to grow out due to toenail growth rates. 
For some, it may take as long as 18 months to 
see a fully involved toenail grow out. At 3 and 
4 months, our providers have documented evidence 
of unsurpassed efficacy with no adverse events.

Most of our providers are finding this to be 
podiatry’s best new technology with the biggest 
potential for increasing value, differentiating 
practices and simultaneously satisfying 
patients. Additionally, as a cash paid 
procedure, this is proving to be very profitable 
for providers while greatly enhancing cash 
flow.

While not all providers have succeeded (less 
than a handful have not) the rest are thriving 
even in the current economic state. Currently, 
we are limiting our marketing to podiatry for 
numerous reasons, one of which is that it is the 
specialty that deals with this disease. We also 
feel that since dentists have teeth whitening 
and veneers, ophthalmologists have LASIK, 
plastic surgeons have breast Implants and 
liposuction and dermatologists have hair removal 
and Botox, podiatrists can now have and will 
enthusiastically develop their PinPointe 
FootLaser practices.

John Strisower, Chief Executive Officer, 
PathoLase, Inc./PinPointe FootLaser, 
John@patholase.com

Hamish
Thanks for joining this discussion. I am following it with interest and will be facinated with the long term results. I understand there are only a few practioners at present in the UK using this system, are you all joining forces to compare your results?
There are always those who are suspicious of new ideas and concepts but on the other hand there are always those like yourself who are brave and will give new techniques a go. Good luck with the new technique and please keep us posted on success rate.
Wendy

I'll go back a step

.

I said
You replied
Hence the question why did you choose to?

Its relevant because as I said what made you choose too might inspire others to.

Regards
Robert

__________________
Robert Isaacs
Specialist in Biomechanical Therapies
www.Footprintspodiatrysolutions.co.uk

small, yellow, leech-like, and probably the oddest thing in the universe

Semper in excretum sum sed alta variat

To get back a little on the science of the thing, I did my graduate dissertation on low level laser use. Whilst I have probably forgotten much of what I learned at the time, there is evidence to support its penetration through tissue depth. There is a great deal of evidence showing effects on pathogens (bacterial not fungal though) with no negative effect on tissue.


When I first received an email about this system I was very interested, but the construction, data and photos of the attached trial did not give convincing support. I'm fairly sure from all my literature searching that there has been little or nothing looking at lasers and effect on fungal pathogens.
The other thing that immeditely struck me system was how there are probably other commercially available lasers that operate at a similar wavelength, power and pulse rates available, for a much lower cost (without the marketing though).

I remain interested but I'll wait for some more convincing data before I jump in.

Hi
Having just caught up with this thread, I have to thank Hamish for his complete honesty and openess- I know nothing about lasers especially in this field,and I suspect those who have posted so vociferously against it know little more than me, but I would be interested to know the outcome. I fear that the doubters would be left with egg on their face if the treatment worked, became cheaper and more widely available and was taken up by the beauty industry!!

At the end of the day, if patients want the treatment who is to say they shouldnt have it? I have a patient that is desperate for me to try needling his VP- even though the evidence is not there!

Cornmerchant

Hamish

You have earned my deepest respect in your courtesy shown towards some of the well established inner circle of this forum.

You may have noticed that there is one rule for the established and another for the likes of you but this seems to be the pattern on all forums. It appears that Dr Kirby's opinion is a substitute for evidence and engages admiration, whilst your opinion and conviction elicits a typical Pod A "experts" attack. You dealt with it well.

I applaud post number 45. I think your interpretation may encourage others not so well established to discuss treatment modalities that don't yet have a robust evidence base attached to them. Perhaps your erudite response does expose a touch of someone's self promotion?

I honestly find compliance is a great problem with topical fungal nail treatments due to the length of treatment time required to resolution. No amount of evidence base is going to alter this one human failing - its continued application. I therefore look forward to the long term results of the Pinpointe Laser coming through in the months years to come and will be discussing, with patients, the use of laser in the treatment of fungal nail infection. After all some patients do have the intellect to work out for themselves that this may or may not be a successful method of treatment based on cost, risk and the evidence available to date when an effective clinician is prepared to communicate with them.

GB

Hamish:

I want to offer you my apologies for some of my postings, which, now in reading them along with your responses again, I realize that I came across as being far too harsh and condescending than I should have. I guess I do play the "bad boy" here on Podiatry Arena on many occasions, but certainly, in retrospect, I made a mistake with you. In other words, I feel you deserve much better from me. I am sorry for that.

My only thoughts that may explain my response to you is that I am currently living and practicing at the "center of laser nail fungus treatment" for the United States. As a result of the continual barrage of newspaper ads and magazine ads proclaiming how great laser fungal toenail treatment is, myself, and many of my fellow podiatrists here in Sacramento, get lots of phone calls and questions from patients and ask us if we think the laser fungal toenail treatment is worth the $900.00 that is being charged (i.e. cash, credit, but no insurance accepted). If there were any research studies from independent sources that showed it actually worked well and/or had long lasting results, then I would have no problems with the treatment. However, I can't ethically recommend anyone, except the wealthy, spending that kind of money on basically a cosmetic procedure unless I have some data that showed it gave significant and long-lasting therapeutic results.

Good luck with your laser treatment procedures. I am hopeful you will stay a contributor on Podiatry Arena, even after my remarks, so that you can provide us with some follow-up on your patients and posting of photos of your patients as they come available.

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

Kevin, not sure if I agree here that the potential of laser in the treatment of fungal nails should be condemed to the realms of cosmesis. Personally I have no problem with treating patients who wish to look normal. I am going to assume that you do not either as you have also stated your reasons (perfectly acceptable) for not recommending Pinpointe Laser. For the same reasons I cannot recommend dry needling VPs - costs, unsure of the risk to patient and no evidence base to support the treatment. This doesn't mean though that I will not discuss with the patient the avaliability of such treatment.

But the main reason I will not condem this treatment to the realms of cosmesis is a worrying trend here in the UK and that is the refusal for orthopaedic surgery (knee/hip replacement) if a patient presents with fungal nail infection. Discussing this with colleagues we set about trying to find an evidence base to support this trend. Other than for the immunosuppressed/compromised we haven't been able to find anything. There seems to be no evidence to support refusal in the otherwise healthy patient and certainly my post on Pod A did not uncover any edvidence on the international scene either.

We did wonder if the reason for refusal was more likely a waiting list dodge.

So one of the reasons I will not join in any criticism of the treatment of fungus by laser is that it may hold a lifeline to those being refused surgery who have between 1 and 10 chronically infected toenails, unsuitable for oral meds, unable to persevere with a topical application and in need of orthopaedic surgery.

I hope that one day Hamish and his colleagues do deliver the goods as an alternative therapy for fungal nails. After all this is patient choice.

GB

Thank you poster for suggesting I review Ciclopirox. I had thought it was something clever and entirely different to types of paints like, Amorolfine and Tioconazole.
On closer inspection they actually seem about the same.
I have garnered the following information from the website an thought that those who read for sport but do not wade in might like to know the following and gauge it against what has gone before.

The respective proprietary websites make very modest claims and generally advises @12 months of treatment which must be maintained. Perhaps they should update their webpages.

The company states a figure of 36 million sufferers for the USA, and warns of the dangers of oral medication for their potential for serious side effects in cases of immuno-suppressed patients and patients taking other medications as well as the need for periodic blood tests.

The Ciclopirox site is very forthcoming. It states that it works best only for mild to moderate infections, requiring regular (possibly monthly) professional debridement, and an expectation that the treatment program will last 48 weeks. It is advised as a component of management in immuno-competent patient with mild to moderate involvement of the nails without involvement of the lunula due to T.Rubrum.

It warns of caution with diabetes and lactating mothers and application during pregnancy.

This company too has reported that even patients who have been successfully treated have had a recurrence. Advising the continuance of application even when the nails look improved.
They agree that without treatment, the mycosis will continue to infect the nail and untreated nail fungus usually gets worse. One study they quote says that patients with diabetes and onychomycosis have an increased risk of secondary infection and that onychomycosis is associated with a 2- to 4-fold increase in diabetic foot infections.

The very reputable Dr. A K Gupta is one of the doctors they used in their “pivotal studies” (no doubt these studies were in fact paid for by the company as is the norm for any pharmaceutical company) the outcome is out of the hands of the company or at least it is meant to be and has to be taken on trust unless one is implicating the scientists integrity as being erroneous.

If one accepts that Ciclopirox studies were conducted well and honorably by Dr. Gupta and his colleagues, then one can be equally reassured he is doing a good job with the PinPointe as he is also involved in their secondary trials.

An astute observation is that if the manufacturers of Ciclopirox thought that the agent they had developed was efficacious enough to get Dr, Gupta among others to test then they pretty much new it worked before they did so. I have it on trust a key figure in the production of Ciclopirox is actually impressed by the laser and what it does. But this is merely hearsay but I trust the source as a friend.

The Ciclopirox trials excluded insulin dependant patients and patients with diabetic neuropathy, did not trial subjects under 12 years of age, trials have not been conducted in the pediatric population. In its pivotal study the complete cure rate was 5.5% and its “almost clear rate” was 6.5%.
In pivotal study 1 (which was their own I remind you) it managed a mycological cure rate of 29%.
No study has been done to evaluate if it adversely affects the efficiency of systemic medication taken concomitantly, and so it advised to not do so.
Nail plate thickness adversely affected the function of the dose.

The effect on ovine hoof contamination was found to be minimally effective and the elimination of moulds from the hoof material was not achieved. So disappointing for cows with mycosis then. All very thorough because the mice, rat, rabbits, monkey’s and dogs all had a go with it too.


According to the information (if I read it right) Ciclopirox with the following groups were excluded, patients who:
Were pregnant or nursing (or planned to become pregnant).
Had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex).
Were HIV seropositive.
Had received organ transplant.
Required medication to control epilepsy.
Were insulin dependent diabetics or had diabetic neuropathy .
Patients presenting with severe plantar (moccasin) tinea pedis were also excluded.
I gather that the safety and efficacy of using Ciclopirox daily for periods greater than 48 weeks have not been established

A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.


A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail.


So I leap back into the swirling void again, to convey the notion that by the company’s own admission the results are about 12%.
So I implore the poster who achieves 60% to contact the company with their data because the scientists conducting the trial got considerably poorer outcomes. One must be duty bound to report this breakthrough for the greater good.
It really wowed me at 6.5% though

As for anyone else reading this thread with interest, I am talking of treating heavily infected o/m including the matrix not just mild to light cases. And happily do know of topical paint applications and their success better than I thought I did. But it probably explains some of the confusion why a person might actually consider treatment by light amplification by stimulated emission of radiation excessive if one is just after treating mild and moderate conditions with mild paint applications. Personally I am after the resistant conditions using a single focused wavelength not a pulsed low level physio laser. Trust me you really do not want to look down the “sharp end” when it is on. It weighs about 50 pounds and is not like a laser pointer for lectures, well only in that it operates in the red end of the spectrum.

If I figure out how I will find a picture of what I am trying to treat from my images I am collecting. Paint aint going to work with these because it has been tried already… for two years or more.
Patients are asking me (I know I said me again) because they have tried all the general current conventional treatments and have had NO success, so THEY wish to explore new treatments.


Out of interest does anyone else get those floating adverts at the top of the page passing by in this website? Or is it only me? I ask simply because the ads for anti-mycosis therapy is “interesting” and who amongst us uses them. If the laser has attracted such derision how have these passed without comment? I guess it must make money for this website somehow.
Another question, who knows about the specific targeting and destruction of pathogens by specific light wavelength? Now there is something to go digging for.
H

Attached Images

CIMG0509.JPG (2.17 MB, 426 views)

Hi Hamish

I have been reading the comments on this thread with interest.I have a few questions that I would like to ask
-how many pateints have you treated using this method?
-how many of these treatments have been successful
-what is the regrowth rate,if any?
-are there any clinical trials being currently conducted in the UK? If so,by which institution
- is the laser treatment particularly successful against any specific organisms
-Is there published documented clinical trials/evidence base that demonstrates the efficacy of this modality?

Any insight to these questions would be appreciated

Regards

faye

Hello again,
It seems there has been brisk trade on this thread.
As a new visitor to these confines I find it a little confusing. Do some people work as tag teams?
I think it is great to see that passion can be ignited by nail fungus. Who would have thought it?

I would like to thank you all. Some for asking searching questions, some for making me question whether information really is out there, and making me recheck. It is, but you need to look in the right places and it is to be found in cross over research.

I found what I feel is pertinent so I am sure more can do the same. I have limited research capabilities so it shows it is do-able.

Thanks too to those who have found my position worthy of defence purely because I am naive in these waters. I tend to have conversations with people normally and one is able to exchange ideas and information more bloodlessly. Forums are odd places to me, I misjudge them, as they are quite territorial.

The experiential post by ladyfaye was perhaps more relevant than any of mine, I think a great deal of the reasons for "why"? were all in there.
It was from a personal perspective and that of “everyman/woman”.

Research is ongoing. One study is a five year project. I believe anyone could run their own study, all you will need are patients, acceptable protocols/parameters access to the laser and its recommended protocol etc.. and money.

I doubt in all honesty much more can be said.

Previously I stated that specific technological information is proprietary, nothing has changed it still is.
When patents are lodged (pending at present) maybe more can be said. Otherwise exactly what it is doing is their business.
The action of lasers on tissue is well documented otherwise tattoo removing lasers and cutting lasers, eye correction lasers and dental lasers for peridontitis would not be commonplace.
What is happening with this device is simply the redirection of previous knowledge into a specific treatment for the multitude of pathogens involved in nail infection. They often coexist, creating greater resistance to treatment and provide an unpleasant digital reservoir of infection.

Secondary clinical trials are being conducted by reputable scientists in America and Canada, in about 4-5 different sites. Preliminary results will be analysed early next year as part of their longer study.
At present @ 13000 patients in a 12 month cycle are being treated by about 200 Podiatrists, I do not have absolute figures for success rates because I am a practitioner not an employee of the company, and the concept of success depends on what parameters were set to define it and what perspective one is viewing it from.

The laser is effective against a spectrum of pathogens apart from the standard dermatophytes. Again some things you might ask for might make you think the answer to be evasive; but that which is asked for might need proprietary information to answer.
I have said before and I will say again. Professor Harris is a very approachable man and is easily found. Ask the organ grinder if you want the real inside dope. He has been at this for years. He really has.
Check out his cv and his research.
I really am repeating myself though. In dental applications I know laser can vapourise bacteria, and destroy it in tissue without damaging the host. I think you can assume their research has developed further from that point of knowledge. What is actually going on histologically might not be known precisely. But think on this, these are scientists most likely to be found in University positions researching it, not a bunch of podiatrists mucking about with laser pointers.

Hi Hamish

Can I check the power rating and other attributes of the pin pointe system- I have looked quite a lot at the effect of lasers which vary significantly with power/dose/pulse shape and rate and a whole heap of other parameters. Generally 'vapourise' would apply at higher levels that would also cause tissue damage, but that's not to say that they do not destroy bacteria (and possibly even fungus) at 'low level'.

Ian

Ian,
I can tell you it is restricted to 4 watts and has preset non changeable parameters across wavelength/pulse/time etc. All of the real details that interest people are proprietory and therefore protected.
I understand peoples curiosity but some understanding has to be given to the company so that it may protect its position. I might have misused vapourise as a word but I am not sure. I still may be right as it will depend on the way the beam behaves during lasing which is in itself dependent on a range of parameters including pulse and power that changes output or strength. But at that level the accuracy of my reply comes to pieces.I do not know how most ordinary things actually work, and do not bother to find out. My curiosity level is not that high. And as long as I understand the principles explained to me I can adapt to meet the circumstances.
Contact PinPointe talk to Paul Wolfe or George Bryant or ask to speak with Professor Harris or contact Dr. Gupta

Good morning all,

I have read the on going dialogue with interest.

I was very suspicious of this technology when I began using it. It is healthy that you are too.

I have performed almost 850 PinPointe laser procedures over the past 15 months with very good results. Efficacy is 85-90% for patients with moderate infection, i.e. nails with no more than 75% involvement. Those severe cases with 100% involvement, have about a 70 % success rate with 1 treatment and 85% with 2 treatments.

Like so many procedures we perform whether surgical or not, the procedure has evolved and success rates have increased.

We stress prevention following the procedure. We all know that patients will become reinfected if they don't practice daily prevention for the rest of their lives.

The wave length, pulse train etc. is proprietary information.

Hamish, thank you for your kind comments. Kevin Kirby, Your office is just around the corner from mine. Is there some reason you are afraid to come by and see for yourself?

That's it for now. Off to perform laser procedures.

Sincerely,



Michael A. Uro, D.P.M.