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Orpyx SurroSense

Discussion in 'Diabetic Foot & Wound Management' started by Mart, Oct 12, 2016.

  1. Mart

    Mart Well-Known Member


    Members do not see these Ads. Sign Up.
    Hi

    Anyone care to comment on this product which at face value certainly has commercial appeal.

    https://orpyx.com/blogs/news/115807172-smart-insoles-assessing-their-clinical-potential

    I was able to find reference to one small pilot study (the blog above) but unable to find a copy published in peer-reviewed journal.

    I am skeptical regarding the ability to set a meaningful pressure or pressure time integral threshold to protect patient (which would be an improvement over visual inspection) because that threshold will likely vary from patient to patient. Also the reliability of whatever measurement system is being used and need and/or method of calibration is unclear.

    In the absence of sufficient scientific evidence comments based on theoretical consideration or anecdotal experiences may be helpful at this stage. I would like to be convinced because if this product is effective at reducing ulcer and amputation rate then it may represent very good value for the high-risk sensory deprived population.

    Cheers Martin
     
  2. Craig Payne

    Craig Payne Moderator

    Articles:
    7
    There are an increasing number of these 'wearable technologies' for consumer use coming on stream. The market and technology is developing quickly.
    The appeal to novelty logical fallacy underpins them all.
    I can seem them being used to monitor activity levels and pressure levels in those with diabetes; I can see them giving runners feedback on certain gait parameters
    ....the data is lacking if that actually leads to better outcomes!
     
  3. Mart

    Mart Well-Known Member

    Thanks Craig

    I wonder how reasonable it is for us as clinicians and those seeking care to expect manufacturers of emergent technologies to provide sufficient evidence of efficacy before they market products aimed at vulnerable populations such as those at high risk for amputation as complication diabetes?

    From an ethical perspective what should the clinician’s message be to patients regarding how they decide whether to invest in these technologies?

    From a regulatory perspective how aggressively should health profession regulatory bodies impose guidelines to their members regarding how they communicate with their patients regarding the use of these technologies particularly when the clinician stands to profit from their provision?

    In the US the FDA seems to be mapping out its role at a time when health care and consumer technology are blending.

    From

    http://www.bloomberg.com/news/artic...ery-light-touch-on-regulating-the-apple-watch

    “While the FDA oversees devices and applications, other federal agencies also have taken an interest in how these products interact with people's lives, including whether they do what they're purported to do or pose a risk to privacy.

    Some products raised flags with regulators after they've reached the market. In February, the Federal Trade Commission cracked down on some smartphone apps for dubiously claiming to diagnose melanoma based on an uploaded picture.

    The agency has issued several guidelines explaining when it intends to take a closer look at wearable devices and smartphone applications. The FDA's concerns are focused on gadgets and software that try to mimic the function of a medical device — not features that simply track steps or heart rate, Patel said. A guiding question is what harm might be done to a person if a product fails.
    "We are focusing only on the higher end of technology," Patel said. "What are benefits to public health against the risks to public health? We always try to balance that."

    The FDA's guidelines on regulating mobile applications, released in February, leave fitness-tracking and other wellness-related products largely free from scrutiny, while technology used for diagnosis, treatment and prevention will get a closer look. A lot depends on how the device is marketed, Patel said. If a company is promoting a product to assist doctors in making medical decisions, it will require more oversight, he said. In January, the FDA approved a glucose-monitoring iPhone app for the first time.

    The FDA will keep a close eye on emerging technologies that aim to diagnose illnesses or offer recommendations for treatment, Patel said. Apple CEO Tim Cook said on CNBC this month that devices and services such as Apple Watch and the company's HealthKit system may be able to help pinpoint some diseases and cancers in the next several decades.

    "We have to be confident in what we are getting," Patel said. "The trajectory is there and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not."

    Patel said that as more health-related products get into to the hands of consumers, the FDA's oversight responsibilities will become increasingly critical.

    "The FDA has a role to play for providing patients and consumers a level of confidence that they can use it," he said.

    Cheers

    Martin
     
  4. Orpyx

    Orpyx Welcome New Poster

    Hi there,

    It is really exciting to see our technology discussed here! If you would like more information regarding our on-going clinical trials, current data, or product details, please feel free to reply to this post. We look forward to hearing from you!
     
  5. Mart

    Mart Well-Known Member

    I had some contact by email with the manufacturer regarding technical aspects of the device, results of pilot studies and plans for future studies.
    I was extremely impressed by the thorough response I got from the development team, they answered all of my questions thoroughly.

    How effectively use of this device will affect wound recurrence remains unclear, early studies are very encouraging and more rigorous studies are waiting completion.

    The development team will clearly be glad to answer any questions requested from them at this stage.

    One notable pilot study and pending completion of RCT the next year is posted below.

    I'm looking forward to seeing how this product performs as research evidence moves forward; I am more excited and less skeptical at this point!

    Trial Name: University of Manchester & Lancashire Teaching Hospital Multi-Site

    Randomized Controlled Trial (2014)

    PI:
    Description:

    Dr. Andrew Boulton (University of Manchester)
    Dr. Neil Reeves (University of Manchester)

    Randomized controlled trial conducted at two sites (Manchester University and
    Lancashire Teaching Hospital), investigating the use of the SurroSense Rx®
    system in high-risk foot patients (target recruitment of n=96). Patients are
    randomized to either an active (alerting) or inactive (non-alerting) version of the
    device for 18 months.
    Outcomes: A total of 75 patients have been recruited at the Manchester and Chorley sites,

    and, to date, over 188 patient-months of data have been collected with active
    (alerting) versions of the device, 212 patient-months in control states; one and six
    ulcerative events have been seen in these two groups, respectively. This
    corresponds to a relative risk reduction of 83% for the recurrence of a plantar
    ulceration in this patient population.
    Current Stage: In progress – target completion September 2017. Data collection is 70%

    complete.

    Cheers

    Martin


    Foot and Ankle Clinic
    1365 Grant Ave.
    Winnipeg Manitoba R3M 1Z8
    phone [204] 837 FOOT (3668)
    fax [204] 774 9918
    www.winnipegfootclinic.com
     

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