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Shockwave for diabetic foot ulcers

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

  1. NewsBot

    NewsBot The Admin that posts the news.

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    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.
     
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    Admin2 Administrator Staff Member

  3. NewsBot

    NewsBot The Admin that posts the news.

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    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
     
  4. NewsBot

    NewsBot The Admin that posts the news.

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    Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials.
    Snyder R et al
    J Wound Care. 2018 Dec 2;27(12):822-836. doi: 10.12968/jowc.2018.27.12.822.
     
  5. NewsBot

    NewsBot The Admin that posts the news.

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    Extended Extracorporeal Shockwave Therapy for Chronic Diabetic Foot Ulcers: A Case Series.
    Chou WY et al
    Wounds. 2019 Mar 15
     
  6. NewsBot

    NewsBot The Admin that posts the news.

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    Extracorporeal shock wave therapy for treating foot ulcers in people with diabetes: A systematic review and meta-analysis of randomized controlled trials
    OiangruHuang et al
    Canadian Journal of Diabetes; 23 May 2019
     
  7. NewsBot

    NewsBot The Admin that posts the news.

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    Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials.
    Galiano R et al
    J Wound Care. 2019 Jun 2;28(6):383-395.
     
  8. NewsBot

    NewsBot The Admin that posts the news.

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    This clinical trial was just registered:
    Shockwave Therapy for Diabetic Foot Wounds
     
  9. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    SANUWAVE Increases Clinical Symposia Presence With Recent Abstracts and Posters: Clinical Results Using the dermaPACE System in the Treatment of Chronic Wounds and orthoPACE System in Basic Orthopedic Research
    August 01, 2019 08:30 ET
    SUWANEE, GA, Aug. 01, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to provide an update of current clinical events and news involving the company’s dermaPACE System, the only shockwave product cleared by FDA for the treatment of Diabetic Foot Ulcers (DFUs). The dermaPACE System is by far the most studied shockwave device on the market for wound indications; having more than 15 peer reviewed articles, including the two most recently published by JWC discussing the DFU Phase III trial, and over 30 abstracts and posters. This work has established a strong effectiveness and safety profile and helped us gain a solid understanding of how DFUs respond to dermaPACE treatment: increased perfusion, reduction in inflammation, accelerated wound area reduction and wound healing. SANUWAVE is continuing to strive to remain at the forefront of wound care research involving the company’s proprietary Pulsed Acoustic Cellular Expression (PACE®) technology. In addition to forward looking plans for pharma-economic studies involving the dermaPACE System, on-going case series measuring the increase in perfusion after treatment with dermaPACE is on-going at three major universities. A comprehensive evaluation of the effects on wound response to shock count and wound area is on-going in Poland. In the past few months, a number of posters have been presented at major wound care symposia and research forums.

    · Dr. Windy Cole, DPM, Adjunct Professor and Director of Wound Care KSUCPM and Medical Director, UH Ahuja Wound Center presented at “The National”, the annual gathering for American Podiatric Medical Association (APMA) held in Salt Lake City, Utah in July 2019 titled: “The Use of Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds.” This case series discussed results to date of the objective to measure and monitor tissue oxygen saturation levels before and after a treatment regimen using the dermaPACE System on DFUs. Measurement of hemoglobin levels is via the Snapshot NIRS device from Kent Imaging. The on-going series reported wound improvement as measure by wound area reduction and increased granulation while also exhibiting an improvement in tissue oxygenation by 11%. To date, 5 patients have been treated with an additional 5 patients to be enrolled and reported on.

    · Dr. Roberto Cassino, who is affiliated with the Interdepartmental Center Team of Diabetic Foot from Istituto Clinico Città Studi – Milano, Italy, presented at SAWC Spring in San Antonio, TX a poster titled: “Extracorporeal Shockwave Therapy (ESWT) in wound care: state of the art in Italy.” In this poster, Dr. Cassino presented results on the effectiveness of treatment of chronic wounds using dermaPACE System on 50 patients. Significant results included: 25% reduction in wound area after the first dermaPACE treatment, 70% of wounds healed by the end of the study period, and 90% of the wounds with surgical indication completely healed without surgery.

    · The “Effect of Extracorporeal Shockwaves (ESWs) on Osteocytes In Vitro” poster, presented at Harvard Research Day Forum earlier in 2019, shows a study performed by researchers from Harvard Medical School, Brigham and Women’s Hospital, and Veteran Affairs (VA) Boston Healthcare System, and Hangzhou Dianzi University, China. The results shown that on the full range of shockwaves input energy (E1 to E6 setting for SANUWAVE’s orthoPACE System), the viability of osteocytes from cell cultures was slightly impaired when compared to control, which did not affect their viability to orchestrate the osteoblasts and osteoclast activity that are involved in new bone formation. Two (2) days after the shockwave treatment the proinflammatory Tumor Necrosis Factor Alpha (TNF-α) was significantly reduced, which indicates a favorable modulation of the inflammatory process, a key factor in wound healing. Also, shockwaves produce an increase in the angiogenesis Vessel Endothelial Growth Factor (ESGF) on day 4, which is an indication of new blood vessels formation. The intracellular Reactive Oxygen Species (ROS) had a transient increase and rapidly dropped below the normal level, which reduces the possibility of DNA, RNA, and proteins damage that can cause cell death. In conclusion, this study indicates the favorable effects of shockwaves on osteocytes.

    · The “Effects of Extracorporeal Shockwaves on Bone Marrow/Synovium Activation and Articular Cartilage Repair” poster, presented at Harvard Research Day Forum earlier in 2019, shows a study performed by researchers from Harvard Medical School, Brigham and Women’s Hospital, and Veteran Affairs (VA) Boston Healthcare System, Southern Medical University and Hangzhou Dianzi University, China, and Institute of Bioengineering and Nanotechnology, Singapore. For this study 4 mm diameter cartilage defects were created in the knee joint of a goat-model. The cartilage defects were filled with Gtn-HPA hydrogel. The shockwaves were applied, using SANUWAVE’s orthoPACE System, 4 days before the defects were create and 30 minutes before animal sacrifice, which occurred at day 14. The histological analysis shown that shockwaves produce bone marrow activation and subsequently stem cells migration to the joint’s synovial fluid and towards the injured cartilage. Also, stromal and vascular proliferation resulted in neovascularization and tissue repair, which combined with stem cells migration ultimately can enhance cartilage regeneration and repair onsite. The study also shown that the Gtn-HPA hydrogel is capable of recruiting stem cells, which in combination with shockwaves might enhance cartilage repair process and become a viable treatment option for cartilage regeneration. The more active population and the increase in life-expectancy will certainly increase the cartilage problems, which according to analysts will produce a global market size of $2.195 billion in 2025, with at least 15.0% increase per year from 2018 and 2025.

    Kevin Richardson, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE has been the leader in wound care research using shockwave technology for more than 15 years, and we plan to be the continued leader for years to come. Our groundbreaking work in developing our understanding of the dermaPACE System mechanism of action has brought us to the forefront in wound care using our PACE technology. We will not slow down in furthering our understanding of how PACE affects the body’s biological response. You will see a number of posters and abstracts and SANUWAVE sponsored symposia at upcoming medical device shows this fall and next spring. Other peer-reviewed articles will be forthcoming based upon on-going research in perfusion measurement. Additionally, we expect to begin enrollment of our follow-on study supporting our DFU indication. And of course, we fully expect to be active in 2020 in setting the clinical groundwork for expansion into new indications.”

    About SANUWAVE Health, Inc.
    SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.
     
  10. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Improved Healing of Diabetic Foot Ulcer upon Oxygenation
    Therapeutics through Oxygen-Loading Nanoperfluorocarbon
    Triggered by Radial Extracorporeal Shock Wave

    Sheng Wang et al
    Oxidative Medicine and Cellular Longevity 14 August 2019
     
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