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Vasyli medical products

Discussion in 'Diabetic Foot & Wound Management' started by Orthican, Sep 3, 2014.

  1. Orthican

    Orthican Active Member


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    Good day all

    I had a recent trip to Halifax for a CAPO conference and was looking at a product called "Sensitive Feet Orthotic" that is put out by the Vasyli group.

    There is a shear reduction zone built into the front and they are indicating use in the plantar ulcerated forefoot. I was always of the school of thought of presure offloading and shear reduction but not just shear reduction alone. I will typically custom make a total contact foot orthosis using tri lams or equivalent paying particular attention to creating an orthosis that has no peak pressures anywhere. The product in question does not have a forefoot that is moldable due to the costruction of the shear reduction zone.

    So I ask: Has anyone used these?

    http://www.vasylimedical.com/products/product_armstrong_orthotic.html

    If so does the shear reduction zone alone provide the effect of aiding the ulcer to heal? I always thought peak pressures played a role.

    Thanks

    Todd
     
  2. Craig Payne

    Craig Payne Moderator

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    Tried to use them, but they are probably too thick under the forefoot.
     
  3. Boots n all

    Boots n all Well-Known Member

    An interesting product, here it is sold as the Armstrond device.

    l am not sure how well it really works, how much shear can it actually reduce if the device fits the shoe neat as it should, how can the first layer move over the second layer when there is no where for it to go?

    CP they do fit well into any extra depth product, but just not in your high heels;)

    We have put it into Aetrex, DrComfort, Drew and PW Minor, the few clients that we did fit them with are happy, but as to its real results?
     
  4. Orthican

    Orthican Active Member

    Thanks for the replies guys!

    As to the thickness I'm ok with that as we tend to fit extra depth anyway in order to accomadate the tri lam materials. I use the shoes you have mentioned David and also a good runner with depth is the NB 928. I was concerned though regarding the results. I know when one puts forth a product for the marketplace it is the best face that is always put foward as it helps to sell said product. Proof of result is what I'm looking for. The reason? I am skeptical until shown repeatable proof of efficacy. (You should appreciate that Craig :) )

    I'll give this some time to see if anyone else has things to say.

    Thanks again

    Todd
     
  5. TC

    TC Member

    Hi Todd, as Medical Director for the Vasyli Group I had significant involvement in the design and development of the Vasyli – Armstrong Sensitive feet (formally Diabetic) Foot Orthotic. You raise a number of interesting points that I would be happy to address with you.

    First some background to the device. The shear reduction concept utilized in the orthotic was initially designed by a US based company Xilas who, subsequently, became Diabetica. Vasyli has the sole manufacturing rights to this patented technology.

    Although Diabetica conceived the technology they were unable to develop it into a commercial entity either visually or functionally. This is when they approached Vasyli Medical. We took the concept and developed the product to where it is today.

    In developing the device we had to adhere to the US Medical Rebate System SADMERC – DME, Durable Medical Equipment program. Without this, patients have no medical rebate on the devices and Physicians would not prescribe them. A very important component to getting them under the patient’s feet!

    The required code is the HCSPC # A5512:
    For Diabetics only, multiple density insert, direct formed, molded to foot after external heat source of 230 degrees Fahrenheit or higher, total contact with patients foot, including arch, base layer of ¼ inch material of shore A35 durometer or 3/16 inch material of Shore A40 (or higher), prefabricated each.

    Working to these guidelines meant the fore foot thickness was more than we would have preferred. However, considering the initial application was for high risk diabetics, as you point out, extra depth shoes should be a given. In function, the Plastazote layer allows for deformation under the foot which further reduces the thickness of the Orthotics fore foot depth profile.

    With regard to your comment on peak pressure offloading and total contact, the fore foot shear reduction zone is fully heat moldable (it has to be to make the HCSPC coding) and works just as well as a tri laminate in offloading fore foot peak pressures. Its construction of EVA, shock-absorbing material and Plastazote is no different to many tri laminate constructions. What the Armstrong Sensitive Feet Orthotic has in addition is a shear reduction component.

    You raise the point of function in the shoe. With footwear constructions and even more so in a true Diabetic shoe, the upper is invariable soft to allow for comfort - movement of the foot. This is where the device’s top layer is able to move with the plantar surface of the foot. It is this ability to reduce the shear factor that makes a significant difference in clinical outcomes.

    The link you provided has 2 papers listed: GlideSoft Clinical Trial - GlideSoft Scientific Trial both of which are referenced in David Armstrong’s video where he talks about the product. As far as clinical / scientific validation is concerned I think these speak for themselves as to the function of the technology and its clinical efficacy. In addition, there is a case study documented on the website utilizing the Vasyli Armstrong Orthotic and Dr. Comfort footwear you may find interesting. http://www.vasylimedical.com/resources/case_study_edp.html

    Just a note on the “Sensitive Feet” name change. In addition to broadening the devices appeal to clinical conditions beyond Diabetes such as Plantar Fat Pad Atrophy, Hyper Sensitivity and Arthritic foot conditions we actually made a few design updates with the Sensitive Feet device. It is wider than the original model, yet trimmable to fit a range of width fittings. We also reduced the fore foot thickness of the EVA from the ball of the foot forward, a modification now allowed by the HSPCS coding.

    Todd, I hope this goes some way to answering your questions. However, I believe the adage “The proof of the pudding is in the eating”. I’d be happy to discuss trialing some product with you to see for yourself its effectiveness in both prevention and treatment of plantar ulcerations.
     
  6. Orthican

    Orthican Active Member

    Thankyou TC for replying.

    So the forefoot zone is heat moldable? I was told by the rep that it was not due to the elastisized bands? Does something happen to the effect if misshapen? I'm wondering if a bowl effect that might be created by a plantar third met head might create a zone of reduced glide due to the curvature. Having said that I wonder though how often replacement might be needed. Have you followed anybody beyond a year using them? How long so far? I see there is a place for this (not for everything) but for some. I would certainly be interested in a trial with them. I would in fact be happy to receive a few sets of differing sizes. ( I cannot depend on size for sure each time out so having them on hand would help) I have approx. population diabetic with healed or healing wounds in the hundreds. I have been following some for 8 years. These would work for some.
    Are you into it?

    If so send me a message
     
  7. Orthican

    Orthican Active Member

    No message yet regarding trial. I will take that as a no then.

    Thanks for the information though!
     
  8. Lab Guy

    Lab Guy Well-Known Member

    "In developing the device we had to adhere to the US Medical Rebate System SADMERC – DME, Durable Medical Equipment program. Without this, patients have no medical rebate on the devices and Physicians would not prescribe them. A very important component to getting them under the patient’s feet!

    The required code is the HCSPC # A5512:
    For Diabetics only, multiple density insert, direct formed, molded to foot after external heat source of 230 degrees Fahrenheit or higher, total contact with patients foot, including arch, base layer of ¼ inch material of shore A35 durometer or 3/16 inch material of Shore A40 (or higher), prefabricated each."


    Perhaps you can design them differently for all the countries outside the USA where the Medicare requirements do not apply. Also, a lot of diabetics who are younger than 65 can also benefit from them.

    Steven
     
  9. TC

    TC Member

    Todd,

    Apologies for the extended period of silence. I have been traveling extensively and not catching up with the posts.

    I would be happy to organize some product however I need your details etc. You can contact me directly at tmitchell@vionicgroup.com
     
  10. TC

    TC Member

    Steven, good point!

    We have some development looking at uprating the materials for just that application as well as shear reduction in sports footwear. Stay tuned.
     
  11. Craig Payne

    Craig Payne Moderator

    Articles:
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    Terry - how about making the product available as a 'top cover with the forefoot extension' that we could stick on other orthotics, esp custom devices - I would like to use them in patients with rheumatoid arthritis.
     
  12. Orthican

    Orthican Active Member

    No problem!:drinks

    I should have given it more time for you to respond but I guess I just get used to trying to get things happening fairly quickly when I see something I would like to try.

    I'm glad we can do it. I will send you an email and we can get to it.
    Thank you
     
  13. TC

    TC Member

    Craig,

    We did design a "front end" for possible use with a custom shell for instance. Let me check back - I think we only opened one mold (Large) at the time. If I can get some made up I'd be happy for you to try them out.
     
  14. Orthican

    Orthican Active Member

    Hi

    I would like to thank you Terry for sending me the samples of this sensitive feet orthotic. I am impressed with the follow through. I will now do my part and report here what has taken place over time with their use.

    Thank you again Terry. :drinks
     
  15. TC

    TC Member

    No worries Todd. Feel free to contact me with any questions. I look forward to hearing your thoughts.
     
  16. TC

    TC Member

    Craig,

    I have had some "front end" GlideSoft devices made up. Drop me an email @ tmitchell@vionicgroup.com so we can organize getting some to you.
     
  17. Orthican

    Orthican Active Member

    Good day

    I wanted to provide Terry an update to my use of the "sensitive feet" product with the glidesoft technology. I have been quite impressed Terry with the samples I was given and so much so that I ordered several more in all sizes. I have used these on those with heavy callus who are considered "at risk" for diabetic wound and for the docs that sent them to me and the patients themselves we now have reduced their risk significantly. I say this because the reduction in callus has been significant in some and has decreased in others. (compliance sometimes is a difficult thing for people)

    With minor modification to heat mold and /or add materials to provide more offload in areas needing pressure reduction I have found these to be a very useful addition to my toolbox. These are an inexpensive way of dealing with those at risk and I will continue to use them more often as I now have great confidence in the product.

    Thankyou for allowing me to try the first sets Terry and I can assure you that I will be purchasing more for a long time to come.


    Thanks again.
     
  18. TC

    TC Member

    Cheers Todd I appreciate the feedback. After all is said and done it's positive patient outcomes we all strive for.
     
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