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'Footbeat' for plantar fasciitis and to improve circulation

Discussion in 'Biomechanics, Sports and Foot orthoses' started by Craig Payne, Jan 12, 2017.

  1. Craig Payne

    Craig Payne Moderator

    Articles:
    6

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    Just came across this today, due to this announcements that they raised $7.6 million for marketing of the 'Foot Beat' (Micro-Mobile Compression). In the announcement was this:
    From the Press Release:
    From the companies website:
    There are 4 'studies listed on the website: http://footbeat.com/medical-research/
    While it appears to affect physiological parameters in a positive way; that is not 'clinically proven'; the FDA is going to investigate if they continue making those claims.

    I did find the patents underpinning the device:
    FOOT COMPRESSION SYSTEM
    INSOLE FOOT COMPRESSION SYSTEM AND METHODS
    Treatment and/or prevention of medical conditions via compression
    FOOT COMPRESSION AND ELECTRICAL STIMULATION SYSTEM
    FOOT COMPRESSION SYSTEM
    Foot compression system
    Watch this space...
     

    Attached Files:

  2. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    From the website on using it for plantar fasciitis:
    It’s your lucky day.
    This: "Increased circulation is proven to ease pain caused by plantar fasciitis" .... I not aware of any "proof"; would love to know what the company thinks is proof. However, that claim means this is approaching the snake oil category.
     
  3. Craig Payne

    Craig Payne Moderator

    Articles:
    6
     
  4. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    Appears to be based on this concept;

    Chronic plantar fasciitis is mediated by local hemodynamics: Implications for emerging therapies
    Larry E Miller, Daniel L Latt
    North Am J Med Sci 2015;7:1-5
     
  5. Footbeat Recovery

    Footbeat Recovery Welcome New Poster

    Footbeat's effectiveness is clinically proven and has been documented in three, peer-viewed independent conducted clinical studies evaluating blood flow and athletic performance. Learn more about the studies at Footbeat.com - Medical Research page.
     
  6. Craig Payne

    Craig Payne Moderator

    Articles:
    6
    Thanks for stopping by...
    I don't think 'clinically proven' means what you think it means. None of those 3 studies are clinical studies. Its effectiveness is NOT clinically proven.

    The Dohm study looked at velocity of circulation
    The Charles study looked at venous function
    The Millán study was on lactate clearance.

    They were good well conducted studies with promising results. BUT, none of them are clinical outcome studies. To claim it is "clinically proven" is approaching having the product labelled as pseudoscience, 'snake oil' and trigger a FDA/FTC investigation for unsubstantiated claims.

    eg based on Charles study, the improvement in venous function may or may not result in less DVT's .... but it was NOT a study on DVT's, so it is NOT 'clinically proven' ... the link is hypothetical and theoretical. That is what snake oil salesman do (unless that is the pathway you wanting to head down).

    NOTHING in those 3 studies relate to the claims you are making for plantar fasciitis and other musculoskeletal problems.

    Making stuff up and wishing it was true is a fallacy and will be seen for what it is,

    I am not saying the product does not work or help (I hope it does); it is just if you are going to make health claims for a product, then they had better be substantiated with proper clinical evidence if you want to avoid legal issues. We have seen this pattern so many times before with new products coming to market. Shame that no one learns from that history.
     
    Last edited by a moderator: Jan 13, 2017
  7. Footbeat:

    Please provide research evidence that "Footbeat" is "clinically proven" to treat plantar fasciitis any better than other in-shoe supports. I won't hold my breath.
     
  8. scotfoot

    scotfoot Active Member

    Hi Kevin ,Craig

    The device in question seems, in part , to work by compressing the tissues overlying the vessels of the PVP causing the vessels to collapse and eject the blood contained within them into the post tibial veins . Therefore we have force transmitted from the skin collapsing veins located more deeply in the foot musculature . So can this concept be taken and applied to advantage in other areas of medicine ?

    What about the following .
    If you wanted to inject a medicine into a muscle but not into a vein and a self aspirating syringe could not be used , could you apply compression to the skin at the injection site and collapse the veins in the muscle during the injection of the medicine , so that the injected material could not be injected directly into the venous system .

    For example , and speaking hypothetically , lets say you inject a material into a muscle with a standard syringe and a needle penetration depth of 2cm . You would ,of course , run the risk , however small ,of injecting directly into a vein (I realise that this risk is site and depth dependent and for example considered low if the injection is made on the outside of the thigh to a prescribed depth ) .
    However ,what if you took a circular disc of metal ( with a diameter of 3-4cm ) with a small hole at its center and first firmly pressed this disc down onto the skin at the injection site . Then whilst maintaining pressure on the disc , inject the hypothetical medication into the muscle through the hole in the disc. Might it be that the pressure from the disc would collapse the veins at the injection site and thus prevent any material being injected into them ?

    Perhaps , if research shows the concept is valid , the disc and injection apparatus could be incorporated into an auto injector system .

    Tests might initially involve ballistics gel , pressure applying apparatus with different end point diameters and pressure sensors at the appropriate depth in the gel .

    Any thoughts ?
    Gerry
    NB The above merely introduces a point for discussion and should not replace the advice and direction of a prescribing physician .
     
  9. William Fowler

    William Fowler Active Member

    And where are those products now? I too have seen that pattern of the way that claims are made. None of them were game changers and many of them are no longer around.
     
  10. Footbeat

    Footbeat Welcome New Poster

    I am the CEO of Footbeat and came across this thread regarding our product. As a relatively new company, we are still in the process of developing our marketing material, including our website. You will notice several changes over the next few weeks as we prepare for our product launch. I appreciate the feedback on our use of “clinical” and are making sure it is used correctly going forward.

    We are very proud of our product and the science it is based on. I would be more than happy to discuss the product in detail or to set up a conversation between you and our chief medical officer, if that is of interest.
     
  11. scotfoot

    scotfoot Active Member

    Dear Footbeat CEO
    Have you yet had time to investigate the effectiveness of your product on the intrinsic minus foot ? I ask because ,as far as I am aware , it has never been shown whether or not PVP function is affected by atrophy of the intrinsic foot muscles . I suspect that PVP function is compromised in the intrinsic minus foot and feel that the effectiveness of your device on such feet ,when compared to controls ,may provide some insight into what I believe to be an important matter .

    Like your company I believe the PVP to be a very important part of the circulatory system and wish you every success with your product .

    Kind regards

    Gerry
     
    Last edited: Apr 5, 2017
  12. Footbeat

    Footbeat Welcome New Poster

    Gerry,
    Thank you for the well wishes. We have not done an investigation into Footbeat's effectiveness on people with intrinsic minus foot, although it is an interesting area. However, we will be initiating a pilot study with the Baylor College of Medicine in Houston on the impact of Footbeat in preventing diabetic ulcers with a secondary outcome looking at peripheral neuropathy. We might gain some insights from that study when we measure venous flow and if there is a notable difference in those with the severe PN. That study will also look at gait & balance and edema. Our anecdotal observations and individual case studies suggest positive results in for both PN and edema. We certainly hope the study bears this out.

    Let me know if you have any other questions.

    Best Regards,

    Matt
     
  13. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    This clinical trial was just registered:
    Micro-mobile Foot Compression and Diabetic Foot
     
  14. scotfoot

    scotfoot Active Member

    Hi Matt
    Have you considered using the Footbeat device in combination with NMES . That is to say using the two systems simultaneously ?
    The rational behind the question is that your device works by applying force to the sole of the foot which is then transmitted , mainly via viscoelastic muscle tissue , to the veins of the plantar venous plexus which then collapse and eject blood . I suspect that if the intrinsics are in a state of active contraction then the forces applied by your device might be better transmitted to the PVP and so produce a more forceful emptying of the plexus .

    The level of electrical stimulation would not need to be very high with the state of contractile activity in the intrisic foot muscles being intermittently raised to only a little above the normal resting tone of the muscle .
    If proven to be effective then perhaps a similar "combined" system could be tested for the calf muscle pump so that intermittent compression and NMES could be used simultaneously and to greater effect than intermittent pneumatic compression alone .

    Regards

    Gerry
     
  15. Footbeat

    Footbeat Welcome New Poster

    Hi Gerry,

    Thanks for reaching out. This is something we have talked about internally for quite some time. We have considered muscle stimulation in combination with active compression. In fact, we filed for a US patent on muscle stimulation in the calf region coupled with compression via Footbeat. In terms of muscle stimulation in the plantar region, we felt it was more efficient to apply direct pressure via our footpad then to contract the muscles, or do both simultaneously. We have found that muscle stimulation can be irritating to some patients, where as direct compression seems to be well tolerated; the same as taking a step. In our research, we have also found that foot compression alone generates a sufficient venous peak velocity to inhibit platelet aggregation and blood clot formation. This is supported by the work that Gardner and Fox did in the early 1980s on the pvp and with their introduction of pneumatic compression for the foot soon there after. So I do not believe we will be using both in combination on the foot, but as you pointed out, combining NMES with the calf could be interesting.

    Thanks again for the note.

    Regards,

    Matt
     
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