Laser treatment for nail fungus

The answer is Evidence Based Medicine will win the day.

From Podiatry Today this month


Emphasizing The Importance Of EBM When It Comes To Laser Care For Onychomycosis

VOLUME: 23 PUBLICATION DATE: Oct 01 2010

Issue Number:
10 October 2010

I read with concern your Point-Counterpoint article, “Laser Care For Onychomycosis: Can It Be Effective?“ in the May 2010 issue.

In the modern practice of medicine, there are two separate but mutually supporting doctrines in what is known as evidence-based medicine. The first doctrine is “to treat individual patients with acute or chronic pathologies by treatments supported in the most scientifically valid medical literature.” The second doctrine is “the systematic review of medical literature to evaluate the best studies on specific topics.”1

Given the above, I must take exception to a scientific conclusion described within the laser article. When discussing the 1064 nm Nd:YAG laser, John Mozena, DPM, states that the single wavelength of light causes destruction of the fungal cells in onychomycosis (see page 56 of the May 2010 issue).

To my knowledge, there are only two peer-reviewed and published studies looking at existing near- infrared lasers in vitro to destroy fungal cells, other than the data published on the Noveon laser. The first, conducted by Vural and colleagues in 2008, showed that a Q-switched 532 nm light (visible green) laser in the Nd:YAG family was actually superior to all other systems tested, including a traditional 1064 nm FRP Nd:YAG in T. rubrum inhibition.2

The authors concluded their study with the 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.”2

The second study used a femtosecond infrared titanium sapphire laser, which pulses at 10-15 of a second. This laser did successfully inhibit growth in vitro of T. rubrum.3

At present, if one were to take a critical look at the available published peer-reviewed literature that discusses all lasers used in vitro and in vivo in the IRB-controlled human treatment of onychomycosis, one would realize that the entire body of this research comes from scientific and medical testing with the new Noveon laser, with two of the studies published in the Journal of the American Podiatric Medical Association.4-8

In the most recent publication, Landsman and colleagues tested the Noveon laser with key parameters in an IRB-controlled pivotal human study.4

1) The study involved single blinded and control patients treated identically in all respects to patients who were actually treated with the laser with
the exception of the sham (placebo) laser treatment.

2) There was an independent expert panel of podiatrists that used baseline photographs to classify each toe in the study as mild, moderate or severe involvement at the outset. The members of the panel were blinded as to which photographs came from treated patients or control patients.

3) The same panel used follow-up photographs to grade clinical improvement subjectively in the nails. The data was statistically analyzed and produced by an independent clinical research organization that is certified to perform this function for the FDA.

Where Is The Evidence On The Other Lasers?

As of this writing, there are four different Nd:YAG lasers and two different diode lasers being marketed to podiatrists as being able to treat onychomycosis, and there is not a single peer-reviewed, IRB-controlled, blinded study among them to justify onychomycosis treatments with these devices. Also, not a single research group has come close to producing the five years of predicate in vitro, animal, cadaver and IRB-controlled human studies with any one of these lasers that my team has published with the Noveon laser, leading up to the treatment of human onychomycosis.4-8

Therefore, until such time as any Nd:YAG or near-infrared diode laser has been tested and has published peer-reviewed evidence that matches the rigor of our team’s efforts during the last five years, I will continue to take exception to comparisons with any “anecdotal evidence” for one of these lasers.

In my opinion, podiatric physicians who would deem to use such a system to treat their patients with mycotic nails should ask the following evidence-based question of the manufacturer: Are there any peer-reviewed and published IRB-controlled human studies describing the safe and efficacious use of this system in treating onychomycosis?

*— Eric Bornstein, DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com

References
1. Selvaraj N, et al. Evidence-based medicine - a new approach to teach medicine: a basic review for beginners. Biol Med 2010; 2(1):1-5.
2. Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on trichophyton rubrum growth. Lasers Med Sci 2008 Oct; 23(4):349-53.
3. Manevitch Z, Lev D, Hochberg M, Palhan M, Lewis A, Enk CD. Direct antifungal effect of femtosecond laser on Trichophyton rubrum onychomycosis. Photochem Photobiol 2010 Mar-Apr; 86(2):476-9.
4. Landsman A, Robbins A, Angelini F, Wu C, Cook J, Bornstein E. Treatment of mild, moderate and severe onychomycosis using 870nm and 930nm light exposure. JAPMA 2010; 100(3):166-177.
5. Bornstein ES. A Review of current research in light-based technologies for treatment of podiatric infectious disease states. JAPMA 2009; 99 (4):348-352.
6. Bornstein E, Hermans W, Gridley S, and Manni J. Near infrared photo-inactivation of bacteria and fungi at physiologic temperatures. Photochem Photobiol 2009; 85(6):1364–1374
7. Bornstein ES. Treatment of onychomycosis using the Noveon® dual-wavelength laser. FDA Pivotal Study data presented at Council for Nail Disorders 13th Annual Meeting, San Francisco, CA, March 5, 2009.
8. Bornstein ES, Robbins AH, Michelon M. Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the Noveon dual wavelength laser system. In Proceedings of the 9th Annual New Cardiovascular Horizons, p.72, New Orleans, LA, September 10–13, 2008. New Cardiovascular Horizons, Lafayette, LA.

 

Yes Jep we got that already.
So FDA means nothing? I live in the UK so it is difficult for me to understand the FDA and what it is. It seems more difficult to grasp than I thought.This is what the FDA thinks it is doing:
FDA is responsible for:
Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation

Regulating tobacco products

Advancing the public health by helping to speed product innovations

Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health

It just seems someone should tell them that they are meaningless. And it could save the US economy a fortune.

 

Thank you Kevin.

Everyone,

As regards the FDA, a simple way to look at it is this:

1. Is a product harmful to the patient? ie is a new titanium STJ arthroeresis implant dangerous to the patient? is a laser (properly used) going to harm the patient?

2. At a much higher level of approval: Is the product EFFECTIVE? This requires exhaustive studies. ie does a laser cure fungal nails?

Many current treatments can't really stand up to this, or at least the studies haven't been done.

But still, I must be missing something because no one has explained how the laser penetrates to the deeper fungus, and how does one treatment clear up the fungus for all time?

65% clear new nail growth does not mean cured. And I have found that patients want ALL their nails clear. Going from 5 fungal nails to 1 fungal nail is not a successful outcome from the patient's standpoint. That kind of result is like one breast implant.

Cheers

 

Frederick:

Let me address how the Noveon system penetrates to the deeper fungus from a photo-physics and photobiology perspective. When one has proven fungicidal energies (870nm and 930nm), this can be accomplished by using optical Monte Carlo effects to target sub-unguanal disease in Onychomycosis Patients.

The important optical parameter for successful Onychomycosis treatment with low energy 870nm and 930nm (near-IR) wavelengths is the 3-dimensional shape of the internal Energy Density (fluence) distribution (exposure) in diseased nail tissue. A correct 3-dimensional shape will ensure an adequate Energy Density threshold in the sub-unguanal areas of the nail, to photo-damage fungus.

Monte Carlo tissue simulations with near infrared energy forecast that if an irradiation spot size becomes “broad-beam” (1.0 cm diameter or larger), and if the energy profile of the beam were to be a flat field (top-hat effect vs Gaussian), the optical energy would then be able to achieve a higher fluence distribution deeper in the nail bed.

With the above logic, my team envisioned a device that would project at least a 1 cm spot “flat-top’ profile (~1cm for small toes and ~2cm for large toes). Hence, the area of nail and surrounding tissue would be treated, so that it would not be defined simply as the tissue under the laser beam, i.e. pi x (radius)2, but more importantly the treatment volume i.e. (pi x (radius)2 x depth), of the nail tissue.

A Top-hat pattern also gives a uniform Power Density and Energy Density to a potential therapeutic site, along with allowing for the initiation of Monte Carlo effects at larger spot sizes.

The Noveon therefore was built to meet the following criteria for safe and practical Toenail treatment:

1) The internal fluence distribution to the nail tissues would be augmented via a Monte Carlo effect, with the remaining laser energy not absorbed in the proximal tissues.

2) The illumination zone of treated nail tissue given by (pi x (radius)2 x depth) will be generated by large collimated irradiation spots.

3) With larger spot sizes, the treatment area will be defined by the area of tissue volume under the beam where the fluence (Energy Density) is higher in the sub-unguanal areas than would be possible (because of energy absorption) with a Gaussian profile, via Monte Carlo forecasts and calculations.

These important mechanical and photobiological conditions cannot be met with conventional laser fiber delivery systems.

This is why the Noveon system "takes the Dr. skill out of the equation". It delivers the same dose every time, after simple clipping and debriding of the nails prior to therapy.

The system was designed to treat 4 toes simultaneously (and hands free) in 3 or 4 simple secessions (over 120 days) depending on the extent of the disease.

Hope it helps.

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies

 

Hi All,
The topic is quiet interesting and I came to know about a new treatment for nail fungus that is laser treatment. But I do have certain clarifications they are:
what are the causes for nail fungus and what is the principle that lies behind:drinks in treating the nail fungus with laser light.

 

Eric

Thank you for your response. I now understand better the effect of the PinPointe laser. The "fluence" is the brightness or intensity of the near infrared radiation.

So, the visible surface of the fungus under the nail plate is radiantly heated by the near infrared laser, and beneath the surface (because the fungal material is not transparent) the fungus is heated by conduction of heat, presumably primarily by the moisture in the fungal material.

Any idea what temperature is required to kill the fungus? Because the treatment requires a fairly long period of time, the temperature must be relatively low, or the patient couldn't tolerate it. Perhaps there could be a less expensive way of heating the nail. Would a hot bath be a high enough temperature?

Cheers

 

I have said before and will now say so again - if PinPointe would like to arrange for me to have access to a system I would be happy to organize a peer reviewed, ethics approved study at the institution I work at.

Can't get better offers than that.

 

They are currently in the throws of a 5 centre trial, and have spent somewhere in the region of f2 million $; details can be found on the net and who is involved. Possibly Adam Landsman could answer some questions, not sure but he is involved with them somehow, I believe, hazy on the details. A phone call to them or email probably works, I am not sure they just go looking for people at random.

 

Frederick:

Here is the difference between the Noveon and any traditional Nd:YAG laser.

Noveon Laser

The Noveon (first prototype device fabricated in 2005) is a near-infrared diode laser system that is specifically designed to use only 870 nm and 930 nm wavelengths.

This choice was made on the basis of the published work of Neuman et al, who observed that these specific wavelengths had the propensity to kill both eukaryotic and prokaryotic cells being studied with confocal microscopy.
The killing of these cells was postulated by Neuman to occur as a result of the generation and interaction of toxic singlet oxygen species that are created by the absorption of these energies in intracellular endogenous chromophores.
This device, which combines the 870 nm and 930 nm energies in a multiplexed beam, has shown a unique photo-biological antimicrobial action spectrum in vitro and in vivo.

Additionally, the Noveon has produced safe and efficacious therapeutic results in multiple IRB-approved studies of onychomycosis treated with a 1.5 cm diameter beam spot at physiologic temperatures.

Similar results were produced when treating MRSA in the human nose with a diffuser probe, at physiologic temperatures.

Human studies with the Noveon have also met the published criteria for calculating the Individual Maximum Safe Radiant Exposure (IMSRE) for human pho-Phototherapy Devices


Free-Running Pulsed Nd:YAG Laser

Use of the Nd:YAG laser was first demonstrated 45 years ago by Geusic et al at Bell Laboratories in 1964. Four years later, in 1968, the first medical use of the Nd:YAG laser was reported in the treatment of cutaneous vascular lesions.
Today, clinicians using the free-running pulsed (FRP) Nd:YAG laser have the capability to use pulse durations in the millionths of a second (10-6 sec), allowing for high-peak powers (1–2 thousand watts/ pulse) for the safe and rapid ablation of soft tissues. This is a thermal event.

Exploiting this laser-tissue interaction, a clinician using an FRP Nd:YAG laser has the ability to apply an intense burst of laser energy, for a very short time interval to the tissues being irradiated. This ability will cause quick, safe, and precise ablation of the tissues involved, as long as the physician performing the procedure is particularly careful not to employ pulse stacking. Pulse stacking is an overlapping localization of laser pulses (going over the same spot more than once) that occurs from the inconsistent manual aiming of small to medium laser spot sizes over large areas of tissue.

This will lead to excessive heating of areas of treatment and potentially ablate healthy tissues. The Nd:YAG ablation interaction has been modified to act as a laser antiseptic treatment in vitro, with a reported method designed to eliminate only the microorganisms that cause disease. In three different publications describing in vitro studies, the Nd:YAG laser was used for an antisepsis procedure with a threshold energy density (fluence) proving to be lethal to the pigmented dental pathogen P gingivalis.

These data described the antisepsis fluence as the “ablation threshold” necessary for destruction of P gingivalis. The ablation threshold was defined as the radiant exposure that is toxic to this pigmented pathogen in vitro without damaging the bacterialgrowth media. In these in vitro studies, each laser pulse was delivered through a 320-micron fiber in noncontact mode, diverging in a Gaussian pattern to a fresh 1-mm diameter spot, to avoid the cumulative thermal effects of pulse stacking.

If one were to employ Nd:YAG technology for the antisepsis of T rubrum, it is possible that the frequency doubled Nd:YAG (532 nm, visible green) laser would be the superior choice for laser antisepsis, because there is an endogenous red pigment in T rubrum (xanthomegnin) that would be an apparent candidate, as an absorbing pigment for green light. However, green light would have a very hard time reaching the nail bed, because of the high absorption profile in the keratin of the nail.

Clinical ramifications:

Clinically, an Nd:YAG is hand-held, with Dr. operation on a millimeter-by-millimeter basis. This takes skill and patience from the DPM.

The Noveon is "Hands-free", with computer driven algorythms, deploying the same effective dose every time, while treating up to 4 toes at a time, with full coverage in a single spot for each toe.

Reference for all of the above discussion:

Bornstein E.S. (2009) A Review of current research in light-based technologies for treatment of podiatric infectious disease states. J. of the Am. Pod. Med. Assoc. 99 (4), 348-352.

Hope it helps.

Eric

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com

 

Having exposed your rather spurious qualifications, why would any legitimate organisation choose you as an independent?

What exactly makes you fit to do the study?

 

Eric

The killing of these cells was postulated by Neuman to occur as a result of the generation and interaction of toxic singlet oxygen species that are created by the absorption of these energies in intracellular endogenous chromophores.


Singlet oxygen would be quite toxic to any living tissue and could explain the deep effect on the fungus material without a significantly raised temperature, presumably by diffusion. This is how sunlight "oxidizes" plastic, making it hard and brittle.

However, singlet oxygen doesn't last very long, so what is all this about a single treatment for a cure? Is this true, and if so, how does it work?

Cheers

 

Hi everyone- This has been a fascinating read, if not a little vitriolic. It seems as if attitude is derived from competition to some extent?

I'm searching the web in vain for first hand experiences with the pinpointe laser system. I feel as if much of this discussion is missing the point: many of us patients do not want to have ugly fungus toenails and we're willing to try various methods to get rid of it. The problem is while I am able to find endless information about Lamisil and Penlac there is virtually nothing about these laser systems from those who have tried it.

I first acquired toe nail fungus about 12 years ago. I think the problem was my work boots I wore for a couple years. After hiding my feet for several years I decided to try Penlac. There was zero change. I tried it for maybe 6 months with no noticeable effect. In retrospect maybe I should have been more determined. The Penlac literature said 10% success rate and my doctor told me he had never seen it work. I guess I didn't believe in the first place.

A couple years after that I became single and decided to try more extreme measures if I was going to enter the dating world again. I went to a podiatrist this time and she tried to talk me out of oral Lamisil. She told me "Your toenails won't hurt you." She missed the point too- we don't want the ugliness. I took Lamisil and had a several blood tests over the course of treatment. My liver functions were fine but my mouth tasted metallic all the time- not to mention no beer for three months. Just like my doctor said, the Lamisil cleared up my toenails. Then the fungus returned within 6 months or so.

I have come to realize there probably is no permanent cure for OM. What would be nice is if the laser would cause no side effects while clearing up my nails for a year or two. I can try like crazy to be careful with sterilization and anti-fungal protocols for the rest of my life. But I also believe that on occasion I may have to have laser treatment again if I want to keep clear nails.

Is there anyone out there who has had this treatment and had success with it? It's like a previous poster said: "there's no bark." The pictures Hamish has posted are wonderful but extremely limited. It seems that in this day and age of the internet I should be able to scrounge up a few first hand accounts. Even doctor's web sites usually show just a standard before and after I can find on the pinpointe web site. I'm not saying I don't believe it- I would just like any type of user response.

My girlfriend is turning thirty in about 7 months. She wants to go to Hawaii with a group of our friends who happen to already are going. I realize 7 months isn't that long but it's long enough to get some result.

Anyone have a first hand account?

 

JulyFlame,
the best I can offer is images of my work and a couple of testimonials (I have limited space on my website but will add more as and when? There are also other images I think on the facebook page for the Newcastle Nail Laser Centre. I think the London Nail Laser Clinic have a similar testimonials page and some images too, however it is far more effective (in my experience) than anything I have had at my disposal previous to this. As for the need to have repetitive laser treatments as a matter of course, that is not the understanding I have, nor do I get that impression from colleagues who have used it for longer than I.
Only you can decide if it is something you wish to try, I would suggest it is very much worth the try. As some might say: "but you would say that wouldn't you?".
Upside is that it is not painful (can feel hot at times).
A good podiatrist should be able to clear off the contaminated nail that often has it looking even worse.
Depending on the scale and penetration in 7 months you should be showing improvement as the treated nail is ejected.
Pity you did not post images of your condition, I could have given you better information, sorry I can't offer you anything else. You could always email them to me directly and I will offer you my view.

 

I have no idea what you are referring to - how are my qualifications fake????

My point however (to keep it on topic) was that I am sure there a many out there who would be happy to help provide the evidence some people are requesting.

As Hamish has stated (and I am sure this is occurring) there are many studies currently underway - will any of them stand up to the scrutiny of people on Podiatry Arena though? And if they don't is that a study or Podiatry Arena problem?

I am sure we will cover all the bases over time.

The fact is "Joe" that you have 1 post and you have used that to "defame" me. Well done. The term for your post is "trolling" - contribute more, troll less.

 

Joe Bean sounds like a made-up name to me. Where do you practice podiatry, Joe??

 

SCP Conference in Bournemouth for anyone interested:
Friday 22 October 11:30-12:30
Bayview room
PRIVATE PRACTICE
Laser therapy for the treatment of Onychomycosis
Dr Adam Landsman, Assistant Professor of Surgery,
Harvard Medical School, Chief, Division of Podiatric
Surgery, The Cambridge Hospital and Adjunct Faculty,
California School of Podiatric Medicine, Samuel Merritt
University, Oakland, CA, USA

 

I just found out a guy in Ohio has been using Q-Switched ND:YAG to treat OM with good results. I wonder if anyone here had similar experience / results?

I understand that, unlike long pulse laser, QS ND:YAD doesn't generate much heat because its pulse width is only about 10ns. And I don't think heating the nail is a must in order to kill fungus (Otherwise I would tell my patients to put a hot water bottle onto their infected toenails instead of paying $$$$)

 

Something of a fair degree of significance has occured to day and it involves this number K093547.
What makes it significant is that it is the FDA 510(k) Clearance Label awarded to PinPointe USA Inc.
Whatever one decides to say about the the device, its relevant cost or whatever, the one thing that one cannot gripe about is that it does not have FDA Clearance. It does.
It would seem that the submission process can be a lengthy one, probably made more difficult because they don't have a benchmark to work off for this type of device.
It would seem that PinPointe are certainly at the cutting edge of this type of development and will continue to research and invest in this area. What they will be able to do is talk openly about their product with doctors in the States whereas up until now the nature of the submission, and waiting for approval, process prevented them from much of that.
So anyone wanting to understand some more and is in Bournemouth for the SCP Conference will find you can talk directly to John Strisower (founder and CEO of PinPointe) Dr. Adam Landsman, Dprofessor David Harris (Director of Science and Regulatory Affairs) Steve Duddy (EVP Sales) and I will be there too. Adam Landsman's lecture should be interesting.

 

So nice to have an oportunity to finally meet Dr Landsman at long last. Great to be able to have a conversation with a wonderful chap. Great interest too from a wide variety of Delegate members in Bournemouth a great bunch

 

I am always skeptical of any hired gun for a company speaking on a conference program.

 

what was it he said that provokes a reaction. He seemed to mention other devices. I think the man's reputaion deserves a littel mre credit than to infer he is some sort of "Lackey of the company". Care to write him your concern perhaps?

 

A 'hired gun' is a 'hired gun'. Those without vested financial interests have more credibility.

 

Then William, you would not have a conference.

Come on put on your grown up suit and join in the world of business and commerce.

GB

 

Here (below) is the only peer-reviewed article describing an IRB-approved and blinded study for human treatment for onychomycosis with a laser, ever published in JAPMA. Dr. Landsman was the PI and lead author.

I am pleased that he is discussing multiple devices in his lectures. There is quite a bit to compare and contrast with the available data.

Let the educated reader, choose his journals and sources to get the best data and analysis available on lasers for OM.

Regards,

Eric


Journal of the American Podiatric Medical Association
Volume 100 Number 3 166-177 2010

Treatment of Mild, Moderate, and Severe Onychomycosis Using 870- and 930-nm Light Exposure

Adam S. Landsman, DPM, PhD *, Alan H. Robbins, MD , Paula F. Angelini, DPM , Catherine C. Wu, DPM , Jeremy Cook, DPM *, Mary Oster, BS and Eric S. Bornstein, DMD

Abstract

Background: The Noveon is a unique dual-wavelength near-infrared diode laser used to treat onychomycosis. The device operates at physiologic temperatures that are thermally safe for human tissue. It uses only 870- and 930-nm near-infrared light, wavelengths that have unique photolethal effects on fungal pathogens. These wavelengths lack the teratogenic danger presented by ultraviolet light and the photoablation toxic plume associated with pulsed Nd:YAG lasers.

Methods: In this randomized controlled study, treatments followed a predefined protocol and laser parameters and occurred on days 1, 14, 42, and 120. Toes were cultured and evaluated, and measurements were taken from standardized photographs obtained periodically during the 180 day follow-up period.

Results: We treated mycologically confirmed onychomycosis in 26 eligible toes (ten mild, seven moderate, and nine severe). All of the patients were followed-up for 180 days. An independent expert panel, blinded regarding treatment versus control, found that at 180 days, 85% of the eligible treated toenails were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth.

Of the 16 toes with moderate to severe involvement, ten (63%) improved, as shown by clear nail growth of at least 3 mm (P = .0112). Simultaneous negative culture and periodic acid–Schiff was noted in 30% at 180 days.

Conclusions: These results indicate a role for this laser in the treatment of onychomycosis, regardless of degree of severity. Ease of delivery and the lack of a need to monitor blood chemistry are attractive attributes. (J Am Podiatr Med Assoc 100(3): 166–177, 2010)

 

Hello to all who have posted here.

Please allow me to introduce myself.

I am Martine Abrahams, owner of The London Nail Laser Clinic. I have been a Podiatrist for 14 years and worked in the NHS for over 10 of those. I am the European Trainer for the PinPointe FootLaser. I do not work for PinPointe, although I do receive a nominal fee for training their new Providers.

In May 2009 I set up The London Nail Laser Clinic with my husband, Michael. He has been qualified for 12 years and runs his full time Private Practice in Hertfordshire.

We took a gamble, both professionally and financially. There was very little evidence to support the claims by Patholase Inc, and now PinPointe USA that this laser works but with lack of any other efficient and safe treatments we thought this was worth a try. Fortunately we were in the financial position that if it all went pear shaped we would be up the creak but could survive.

From the beginning I have been upfront with my patients. They know it is a new treatment with very little supporting data. They are sick and tired of their infected nails and the vast majority have tried anything else they can get their hands on - generally with no success, although some report improvements but not enough to suffice. I do not expect nails treated with the PinPointe FootLaser to miraculously change. I know some damage is irreversible. I even tell my patients this!

I can't talk for all the providers of this treatment, and my worry is that some providers may well be misusing the equipment or misleading the patient, but I know that I am not in it to make a quick buck (Pound Sterling, Australian Dollar or even Euro) but am trying to be the best Podiatrist I can be and give my patients a choice. That choice includes the use of a new treatment, which has been certified as safe to use for this purpose, which may or may not give the desired effect, but the patient decides if it is worth a try.

17 months later, the gamble is paying off. I am seeing many happy patients whose nails are vastly improved. Some better than others of course. Did every patient expect nails which look good enough to model? Of course not, they hoped for an improvement. They hoped to get rid of the fungus that was destroying their nails. They hoped to wear sandals and not be as embarrassed. Has this happened in every case? Unfortunately not. I, along with Michael, Hamish Dow, Dr. Mike Uro and the people at PinPointe are trying our best to understand why not everyone gets the same degree of success and how we can improve.

I do not just go into work and lase a few nails and go home again. Like many of you, I regularly evaluate my work and strive to make it better. I have changed how I treat compared to how I was trained to do so last year. We are constantly evolving and trying out new ways of working with the PinPointe FootLaser.

I would love to treat once and send the patient away knowing they will never be blighted by fungus again. I know it doesn't work like that, my patients know it doesn't work like that. That's why we advise they take measures to prevent reinfection. It is their choice to comply. Most do so. Be it that they have paid a lot of money for the treatment, and this is still part of that treatment, or be it that once they are treated even if they don't see a lot of difference they psychologically feel the fungus is gone and they will do anything to try to stop it coming back.
This is a TREATMENT not a CURE. There is a difference.

Yes, I charge a lot of money for this treatment. I wish I didn't have to. I am an NHS Podiatrist at heart and would like nothing better than to do this for nothing but a basic salary. Unfortunately my outgoings are way too high and my children like to be fed. Having spoken to other Podiatrists, Podiatric Surgeons and Dentist, I do not make as much profit per hour as many of them do. Perhaps I am selling myself cheap. Do I feel too much of my fee goes back to PinPointe USA? Absolutely, but as long as they use it to improve the equipment that I use on my patients in some way, I will continue to work with them.

I hope this explains to some of you sceptics why an ordinary Podiatrist has so much faith in a machine that so many believe does not work as it says it does. I hope you will read this and realise that this laser is another tool in the fight against Onychomycosis and Tinea. I also hope you understand that all those who use it do not do so because of the financial gain. It is a hard slog and not a get rich quick scheme. Yes I make a living. No I don't make a fortune.

Thanks for reading.

Martine

 

Hi Martine

First I'd like to thank you for your frank post. However for me it still leaves some things unanswered.

Just to state were I'm coming from- I have no problem with people charging an amount required to make providing a service economic

I have no problem with a well trained professional making a reasonable living from what they do.

I am not more skeptical about laser treatment for OM than I am about any new treatment. In fact I would love for it to work and will gladly look at investing in this service for my patients should it be shown to do so. I am not hostile to it- I just want to be convinced.

My main problem still lies with that fact that no one has honestly answered why they have invested in this before there was any evidence to support it's use. Financial gain is the obvious answer whether that has materialised or not. Can you elaborate on your thought process at the time a little more?

I am glad you are seeing some improvements, but can you seperate the effect of the laser from the debridement and measures to prevent reinfection? this is why we need blinded studies.

I remain interested
Ian

 

I can't speak for Martine but I can for myself. It is interesting and comforting to know that there are some out there worried about business risks that we choose to take. People tend to fall into personality types those who are risk averse and those who are risk takers.
I ride motorcycles and have parachuted (among other things) and consider that I prepare myself well for such things. So the idea of becoming involved was much less of a real risk merely a business one.
My decision to become involved was founded on several things: To be at the very front end of developing science in our profession, to place myself in a different business market with a usp that sets us apart (this in itself is becoming more difficult year on year), partially financial too & the need for a new challenge. I also spoke with people involved and looked at the likes of Dr. Harris and decided (chose to trust if you like as I tend to trust my judgement) that they seemed like genuine people who know what they are on about. I also dug about and found that engineers are partial to adapting cross over technologies when they can see simiilar applications from different fields. I also found out that research into pathogens, and the effect of energy levels on them, has been going on for years and Dr. Harris has been in this field and has a monumental knowledge on this subject. Just sit and chat with him for 5 minutes and you realise the sheer scale of his understanding and knowledge and his track record.
As for us seeing "some improvements" the photographs I have posted and those that are being collected by myself alone go way beyond the typical changes one sees with typical routine debridement and topical application. I am confident that these changes are indicating greater changes than just eradication of fungal contamination. Beyond that, at present I am not prepared to say any more, because it is currently something I wish to keep to myself.
Blinded studies and reviews are being done and have been done as it formed part of the FDA Clearence process. Photographs are given to individulas trained in planimetry, who have no idea what was treated what was not. There job is to evaluate the scale and percentage of clear nail. It is what the pharmaceutical industry do all the time.

 

Hi Ian

Thanks for your reply.

The answer as to why I went ahead and signed on the dotted line to get one of the lasers is simple.

I heard about it, spoke to various Podiatrists in the USA who were using it, looked at some of their pictures, went to California to Dr. Uro's clinic and saw some patients having the treatment and, more importantly, returning for review appointments with healthier looking nails. I then made a choice between either debriding nails forever and recommending various lacquers, creams and varnishes as well as oral medicines, which I would have no desire to take myself, or signing a year's contract and trying something new.

If you don't try, you'll never know. I went into this taking a calculated risk financially and possibly with the thought that it would be a professional experiment. I was the first provider in Europe but I will say quite honestly that I would not have been the first worldwide - I am not brave enough for that.

From the first treatment that I carried out I have been honest with my patients. They have always known that they are taking a financial risk too. Anyone who I feel has expectations that could not be fulfilled by the use of this equipment I have advised against it. Yes, I have turned patients away!

Unfortunately there has not been a lot of published supporting evidence for this treatment, however I make judgements everyday, both professionally and personally, which cannot always be backed up the way I would like them to be. If you play it too safe in life you get nowhere. I wouldn't take a risk on my patients that could physically harm them and any risk I do take is with their consent and true understanding of what is involved and what the outcomes could be. I usually give the worst case scenario and spend many unpaid hours talking to prospective patients. I really am no salesperson!

I have recently had some photos analysed which are showing good results using the laser. The people analysing these photos were blinded. Of course, this is not the blind study you and so many crave. I would love to do that and would be more than interested in working with anyone who could help me do this.

In respect of why I feel good results are down to the laser and not just debridement and preventative measures, let me give you my opinion. I feel it is a mixture of all three. I take a thorough history from all patients including any other remedies and treatments. I speak to their Podiatrists where appropriate. The majority of patients have used topical treatments and have noticed no difference. Many of my patients are more knowledgeable than I am about what medications they use to rid themselves of OM. Some attend regular Podiatry where they undergo debridement and between appointments use antifungals. Many of my patients have used systemics and either did not complete the course as they could not tolerate the side effects, did not see significant improvements or they suffered a relapse. During my years as a routine NHS Podiatrist I struggled to improve the appearance of patients' nails with all the standard treatments. I have not found any degree of success using those that can rival what I am currently doing.

I often advise patients to have regular debridement, and in the interests of NOT making more money, I recommend they find a local Podiatrist through The Society of Chiropodists and Podiatrists. Some do choose to come to me for routine nail care as they like how I debride. Patient's choice once again.

To be really honest though, I am just pleased I have found a way of helping people - I am in the 'caring profession' after all. I am usually a last resort for people who feel that they have either exhausted all other options or do not have the inclination to try them.

Yes, it would be nice to back everything up with blinded and double blinded studies, but actually sometimes it's just nicer to simply go ahead and try something. The aim of my treatment as a Podiatrist is to help my patients feel better. Whether it is the laser part, debridement part, preventative measure part or a mixture of all of them, I am realizing that aim and that's what I, and my patients, are bothered about. Sometimes I feel that we look into things far too much and as long as we are acting ethically, morally and in the best interests of our patient they will benefit.

I hope this helps a little more.

Regards

Martine

 

Colleagues:

I'm sure you are all envious of me......in my neighborhood I have the "World Leader in Laser Treatment for Toenail Fungus". This advertisement from the Sacramento Bee from October 20, 2010, speaks for itself.

 

Thanks ffor that both Martine and you too Kevin.
Martine I can see you thought about it deeply and took a calculated business risk. I had similar thoughtS.
Kevin, I am a dimmer bulb I can't quite follow. For arguments sake can you pretend it cannot speak for itself and explain specifically what it says. You can be the spokesperson because you speak its language. We do at time seem to be two nations separated by a common language. And what is it that is the problem with Dr. Uro exactly?
Thanks for the help, I appoligise for being slow on these things.

 

Anyone who self proclaims themselves as a "world leader" have a credibility problem.

I have spoken to a number of colleagues in different states who practice in the same down as a PinPointe user. They a e getting an increasing number of bitter patients from these providers.

 

Well that sounds like a crying shame. And yes "World Leader" will put some peoples backs up I guess particularly the ones who have more experience than him.
I was going to post a couple images of before and 12 months later but the page will not let me. Shame really because she is so very happy.
I could only speculate as to the reasons for the anecdotal disappointment, but that's all i could do, speculate.
Sorry about the picture snaffu

 

Unfortunately not every provider does provide the same level of care for their patients. I know both Dr. Uro and Hamish Dow personally and although we are all very different in our approaches to patients, I know that they are both constantly trying to improve technique and better the outcomes of a treatment that we know is not 100% effective. Whatever their reasons for using this equipment I feel that they, and I, have helped more patients with OM since using it than we would do without it.
Unfortunately I have had experience of patients who have been treated in the USA and were not happy with their care. One case in particular where there had been a visible change in the nails but the patient had no follow up so was not sure if her response to treatment was good or not. Having spoken to the Podiatrist who carried out their treatment I could understand the patient's disappointment once I had experienced this man's apathy. I have now seen this lady and she has gone away much happier.
Like all professions, and podiatry in particular, there are always some bad eggs in the basket. Please do not tar us all with the same brush!
Perhaps PinPointe should vet providers more, but with experience, and we are all still learning, the training of new providers worldwide is more thorough and PinPointe are working with providers to try to bring everyone up to the same level. This will take time and unfortunately, as with every treatment and in any profession, there will be some unhappy patients along they way. I cannot imagine that any of us can swear that we have a 100% success rate, either in terms of treatments or satisfied 'customers'. We can only try to work together to support eachother and improve techniques and training as time goes on.

 

Here's an interesting posting from Paul Kesselman, DPM, in PM News from 10/27/10.

http://www.podiatrym.com/letters2.cfm?id=38932&start=1

 

I wonder how much these newspaper advertisements cost??

 

Dear Dr. Bornstein, and whoever else is interested

This study that keeps being quoted only shows a 3mm or 4mm strip of clear nail growth. So, in all this time, there has never been a study that showed complete clearance (cure) of onychomycosis?

My patients want better results than a narrow strip of clear nail. We did better with a CO2 laser and topical antifungal solution in 1985!

So, what's the big deal, other than it's a new laser?

And also, I'm curious. Everyone seems to be a bit cosy about the actual cost/lease and manufacturer's fee per patient for the use of the PinPointe laser. Anyone willing to cough up the numbers? Is this commercially sensitive information? Are we at a point (no pun intended) where commercial sensitivity takes precedence over professional/collegial transparency? Are we no longer going to give up our treatment secrets at conferences?

Cheers

 

Ha ha ha , you guys are funny. As you know I try to be as helpful as I can.
The advert Kevin has mike Uro's telephone number on it 916 920 9292 you could ring and ask him, or The Sac Bee has a classified ad chap:
CLASSIFIED ADVERTISING
Classified Advertising Manager
Kevin Garrity
(916) 321-1399
kgarrity@sacbee.com
You could ring to find out or I could send him an email for him to contact you on the rates.

I think that what is a large part of the discomfort generated is a socio-political one, because it attracts so much criticism for its business model. I think it is noble that people wish for it to be available more cheaply, though it all ends up flavoured by politics and that is a different issue. Personally I am no socialist but if it floats your boat fine, I have no problem with alternative religions either.
For info on the costs either rummage through my posts because I have said what it costs me and how much time it takes me or simply email PinPointe or ring them it think it is 530 809-3800 that way you get to speak to them directly. But long/short you can charge what you like, 3 cents per treatment if you want. Personally I think that for my 4 hour work at @ £200 per hour (inclusive of all my business overheads, not clear profit) is not such an evil rate. You know you could ask to speak to John Strisower if you like, he owns the company but is more than happy to speak with folk when he can. I can vouch that the big guy does not bite.

As for what I understand about planimetry and the pharma industry, it is that they all use a similar system of measuring clear space in nails. I think I am right in saying that the PP studies use the same system as the pharma boys and girls. If you contact Dr. Landsman or Dr. Harris I am sure they can tell you what the system is. They most likely did pretty much did what Penalc and the oral boys probably did to measure improvements when they put their products forward. One terrible problem is the verification of diagnosis and clearance checking because of the high percentage of false negatives. Even the FDA realise this is an issue.

The CO2 laser I think is off label for O/M and has less "evidence" than the current crop of devices. The PP is designed to be less blunderbuss and more specific to molecular tolerances or even smaller targets like protien chains.

Perhaps what some folks are missing on this, is that this is offered as a patient treatment option/choice. In my surgery it is not the case of some hapless infected soul/sole wandering in, and me looking at the condition reaching for the laser and saying: "Right I am going to treat your onychomycosis and you will pay me the princely sum of £730".
Bless, it would seem that is what is in some peoples minds. No, what happens is that many folk arrive looking for an alternative to the traditional pharma approach (let us not forget that does indeed make the pharma indistry much money too). Many do not wish for the laser either becuse it is more than they want to spend. No different to buying a car. just because some folks can't afford a Merc does not stop them from making them. So in my clinic I do my best to offer options and say that I can treat it righ here in the moment if they so wish, then they can choose.
Always a joy
H

 

To paraphrase Churchill,

"Never in the field of human conflict have so many argued so passionatly over so little. "

I really can't bring myself to be that excited about it either way! Its OM, not cancer. I can't see it being the subject of a Panorama special in which darked out anonymous sufferers weep copiously to the camera about their 10 year battle with unattractive toenails. I struggle to imagine Jeremy Vine in his anorak at the end gravely reporting
"after we finished filming, maureen lost her fight with tinea, had bilateral TNA's, and now has to apply stick on toenails when she goes to corfu. Our thoughts are with her family."

Followed by a picture of the nails with a caption of

"maureens toenails, 1954 - 2010, sadly missed"

If the toy works and people are willing to cough up for it, super! If its an expensive way of treating people with debridement and topical antifungals which works (and debridement and topicals remains a good treatment) equally super. And if someone wants to bill themselves as a WORLD LEADER in OM treatment, frankly thats an epithet I would not begrudge anyone.

At the end of the day there is a 100% cure with no recurrance (or near as spit) which is available for a few hundred quid, or free on the NHS, with the only real complication being a mild cosmetic one! So its not really like the market on OM has been cornered!

 

Eeee bless!
can't get excited? and then regale us with your passionate prose I think you can't bear to face the fact you are an om junkie.

I went away after my last visit to this fascinating thread and had a good hard think. You are right; it really needed good hard proper investigative research.
So I got my biggest magnifying glass, and the next patient who came in with o/m got a very thorough eyeballing through the lens I can tell you. And because of that I know exactly what is going on in there.

At first it was hard to see, but if I concentrated very carefully, in the dark crevices one could discern small damaged cells malformed and in a woeful state behaving in a terrible way. I decided that they must surely be heathen for the harm they were inflicting on the nice good skin cells. It was dark with me peering in blocking the light so I got a very strong torch and shone it in. Well you can imagine my surprise when I saw many heathen cells weeping, abasing themselves, and begging for forgiveness under this harsh glare of the torchlight and starting to try to behave better. It was amazing because what I had not noticed were elements within the light trying to sooth and help the heathen particles.
Very quickly I grabbed the laser and fired it in and all of a sudden the situation was changing. The photons in the laser beam are in fact little angels and they were converting and healing the heathen particles. I even took photographs but I think I need a better camera to get decent pictures.
So there you have it the diseased cells are in fact heathen, diabolically possessed particles and photons are in fact tiny little angels and elements of light with the power to exorcise and cleanse. However sometimes the Devil is too strong and they change back again.
In conclusion it would seem onychomycosis is a diabolic possession of nail tissues, and the laser beam contains healing angels, is it any wonder that getting rid of this condition is such a problem. It is all the work of the Devil and is evidence of the original sin.
Thats what I call proper research.

 

My passionate prose was of the thread, not the OM.

But Hamish, I bow before my literary master. You should serialise that.