Welcome to the Podiatry Arena forums

You are currently viewing our podiatry forum as a guest which gives you limited access to view all podiatry discussions and access our other features. By joining our free global community of Podiatrists and other interested foot health care professionals you will have access to post podiatry topics (answer and ask questions), communicate privately with other members, upload content, view attachments, receive a weekly email update of new discussions, access other special features. Registered users do not get displayed the advertisements in posted messages. Registration is fast, simple and absolutely free so please, join our global Podiatry community today!

  1. Everything that you are ever going to want to know about running shoes: Running Shoes Boot Camp Online, for taking it to the next level? See here for more.
    Dismiss Notice
  2. Have you considered the Critical Thinking and Skeptical Boot Camp, for taking it to the next level? See here for more.
    Dismiss Notice
  3. Have you considered the Clinical Biomechanics Boot Camp Online, for taking it to the next level? See here for more.
    Dismiss Notice
Dismiss Notice
Have you considered the Clinical Biomechanics Boot Camp Online, for taking it to the next level? See here for more.
Dismiss Notice
Have you liked us on Facebook to get our updates? Please do. Click here for our Facebook page.
Dismiss Notice
Do you get the weekly newsletter that Podiatry Arena sends out to update everybody? If not, click here to organise this.

FDA permits marketing of device to treat diabetic foot ulcers

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, Dec 28, 2017.

  1. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1

    Members do not see these Ads. Sign Up.
    FDA News Release
    FDA permits marketing of device to treat diabetic foot ulcers

    Summary
    FDA permits marketing of device to treat diabetic foot ulcers

    Release
    Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

    “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

    An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.

    The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.

    The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.

    The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.

    The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.

    The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.

    The FDA permitted marketing of the Dermapace System to Sanuwave, Inc.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efficacy and safety of extracorporeal shock wave therapy for acute and chronic soft tissue wounds: A systematic review and meta‐analysis
    Li Zhang Xiao‐bing Fu Shuo Chen Zhan‐bo Zhao Christoph Schmitz Chang‐shui Weng
    Int Wound Jnl: 19 April 2018
     
Loading...

Share This Page