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Dressings for venous leg ulcers

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, Jun 22, 2006.

  1. NewsBot

    NewsBot The Admin that posts the news.

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    Members do not see these Ads. Sign Up.
    WorldWideWounds have just published the full text of this on their website:

    Four-layer bandaging: from concept to practice. Evidence base for treating venous leg ulcers
     
  2. NewsBot

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    Re: Four layer bandaging for venous leg ulcers

    Todays British Medical Journal has a systematic review on this:
    Dressings for venous leg ulcers: systematic review and meta-analysis
    Simon Palfreyman, E Andrea Nelson, Jonathan A Michaels
    BMJ 2007;335:244 (4 August), doi:10.1136/bmj.39248.634977.AE
    Those with institutional subscriber access to the BMJ, can get the full text here.
     
  3. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Venous reflux surgery promotes venous leg ulcer healing despite reduced ankle brachial pressure index.
    Obermayer A, Göstl K, Partsch H, Benesch T.
    Int Angiol. 2008 Jun;27(3):239-46.
     
  4. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Mathematical modeling of venous ulcer healing rates after implantation of keratinocytes: New ways to predict the efficacy of wound healing after regenerative methods.
    Renner R, Simon JC.
    Wound Repair Regen. 2010 Nov-Dec;18(6):624-8
    Abstract
     
  5. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    Positive Results for Phase IIb Trial of Unique Cell-Based Therapy in Venous Leg Ulcers
     
  6. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    Study shows higher healing rate using unique cell-based therapy in chronic venous leg ulcers
    A unique living human cell formula is applied on leg ulcers in a topical spray, providing 52 percent greater likelihood of wound closure than patients treated with compression bandages only.
    Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial
    Prof Robert S Kirsner MD, Prof William A Marston MD, Prof Robert J Snyder DPM, Tommy D Lee MSHS, D Innes Cargill PhD, Dr Herbert B Slade MD
    The Lancet, Early Online Publication, 3 August 2012
     
  7. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Effects of Hypochlorous Acid Solutions on Venous Leg Ulcers (VLU): Experience With 1249 VLUs in 897 Patients
    Cheryl M. Bongiovanni
    The Journal of the American College of Clinical Wound Specialists; December 2014Volume 6, Issue 3, Pages 32–37
     
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    The use of medicinal plants in venous ulcers: a systematic review with meta-analysis
    Anderson L Freitas et al
    International Wound Journal 9 May 2017
     
  10. NewsBot

    NewsBot The Admin that posts the news.

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    Therapeutic ultrasound for venous leg ulcers
    Nicky Cullum, Zhenmi Liu
    Cochrane 15 May 2017
     
  11. NewsBot

    NewsBot The Admin that posts the news.

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    Healing of chronic venous ulcer with topical sevoflurane
    Adrian Imbernon-Moya et al
    International Wound Journal
     
  12. NewsBot

    NewsBot The Admin that posts the news.

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    News Release
    MiMedx Reports MultiCenter randomized Controlled VLU Clinical Study Accepted for Publication in The International Wound Journal
    Unparalleled Results of 60% healing at 12 Weeks and 71% Healing at 16 Weeks Expected to Expand VLU Insurance Coverage to an Additional $75 Million to $150 Million in annual Revenue Opportunity

    MARIETTA, Ga., Aug. 31, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts was accepted for publication in the International Wound Journal.

    The paper entitled "A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers," was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O'Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article.

    Parker H. Petit, Chairman and CEO, stated, "This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors."

    Bill Taylor, President and COO, said, "The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks."

    Taylor continued, "The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm2 for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm2."

    "While we have achieved Medicare reimbursement coverage for both VLU's and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives," noted Petit.

    Taylor added, "Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million."

    Chris Cashman, EVP and Chief Commercialization Officer, commented, "We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx."

    "We are looking forward to soon reporting the full details of this study when the article is electronically published," concluded Petit.

    About MiMedx
    MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

    Important Cautionary Statement
    This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
     
  13. NewsBot

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    Venous leg ulcer management in clinical practice in the UK: costs and outcomes
    Julian F Guest, et al
    International Wound Journal 15 December 2017
     
  14. NewsBot

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    Trichloroacetic acid (80%) as a chemical debridement method for chronic venous leg ulcers—A pilot study
    Rita R Pinheiro, et al
    IWJ
     
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    Articles:
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    Predicting the likelihood of venous leg ulcer recurrence: The diagnostic accuracy of a newly developed risk assessment tool
    Kathleen J. Finlayson, et al
    International Wound Journal: 13 March 2018
     
  16. NewsBot

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    Articles:
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    Assessing the Healing of Venous Leg Ulcers Using a Noncontact Near-Infrared Optical Imaging Approach.
    Lei J, Rodriguez S et al
    Adv Wound Care (New Rochelle). 2018 Apr 1;7(4):134-143. doi: 10.1089/wound.2017.0745.
     
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    PUBLIC RELEASE: 24-APR-2018
    Early treatment for leg ulcers gets patients back on their feet

    Treating leg ulcers within two weeks by closing faulty veins improves healing by 12 per cent compared to standard treatment, according to new findings.

    The research, led by Imperial College London and funded by the National Institute for Health Research, studied 450 UK patients with the most common type of leg ulcers known as venous ulcers.

    These ulcers are caused by bad circulation in the lower leg and often due to faulty veins in the leg called varicose veins. These allow blood to flow in the wrong direction - towards the lower legs and feet. This causes blood pressure to rises in veins in the lower leg, and these vessels swell and damage the skin.

    This leads to painful open sores that take many months to heal, or in some cases never heal. It is estimated that the NHS manages 731,000 leg ulcers each year, the majority of which are venous. These leg ulcers are more common in obese people, and in the elderly - around one in 50 people over the age of 80 are thought to have a venous leg ulcer.

    Because ulcers can take a long time to heal - and lead to serious complications such as amputation - some estimates suggest their treatment and management cost the NHS £1.94 billion a year.

    In the new randomised controlled trial, published in the New England Journal of Medicine, half of the patients received treatments within two weeks to tackle varicose veins.

    These are usually performed under local anaesthetic, and involve a surgeon destroying or closing the vein by injecting foam detergent into the vein, using laser or heat to destroy the vessel, or glue to seal it.

    In the study the remaining half of patients received treatment to tackle varicose veins after their ulcer had healed, or after six months if their ulcer was still present. All patients were asked to wear compression stockings, which squeeze the blood back up the leg.

    The results suggested that in patients who received varicose vein treatment within two weeks their ulcer healed in 56 days, compared to 82 days in the group whose treatment was delayed.

    Professor Alun Davies, lead author of the research from the Department of Surgery and Cancer at Imperial, said: "Leg ulcers can significantly impact on a patient's quality of life and in severe cases can lead to someone losing part of their limb. They also represent a huge cost to the NHS. However, at the moment, most patients are offered only compression stockings without being referred on for treatment that tackles root of the problem - the faulty vein."

    He added that until now there has been no robust trial to assess whether treatments to close the vein are effective.

    "With this trial we have shown that by intervening early you improve the healing of the leg ulcer, and help a patient recover quicker. We recommend that patients are referred to a vascular clinic upon diagnosis with a venous ulcer, to see if they would be suitable for early treatment."

    In the trial, 450 patients diagnosed with venous leg ulcers were treated at 20 centres across the UK. Half were randomly allocated to receive treatment to close the damaged vein within two weeks, while the other half were randomly allocated to receiving the treatment after the ulcer had healed. The patients were tracked over the course of a year.

    The results suggested that, after 24 weeks, the ulcer healing rates were 85.6 per cent in the group who received rapid treatment, compared to 76.3 per cent in the group who received delayed treatment.

    The authors acknowledge that all patients in the trial received optimal treatment, and say increasing research is needed into the problem of leg ulcers, especially treatment pathways.

    Francine Heatley, trial manager of the study from the Department of Surgery and Cancer at Imperial, said: "As our population ages, and obesity rises, leg ulcers look set to become an increasing issue for patients and the NHS. We need to find the most effective, and cost-efficient, method of treating this condition."

    The added that further analysis showed that early treatment to destroy the vein was cost-effective. This work will be published shortly.
     
  18. NewsBot

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    Dressings and topical agents for treating venous leg ulcers
    Gill Norman, et al
    The Cochrane Library: 15 June 2018
     
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