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Dressings for venous leg ulcers

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

  1. NewsBot

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    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
     
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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.
     
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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

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

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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

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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

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    Therapeutic ultrasound for venous leg ulcers
    Nicky Cullum, Zhenmi Liu
    Cochrane 15 May 2017
     
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    Healing of chronic venous ulcer with topical sevoflurane
    Adrian Imbernon-Moya et al
    International Wound Journal
     
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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
     
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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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    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
     
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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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    A randomized trial of class 2 and class 3 elastic compression in the prevention of recurrence of venous ulceration.
    Milic DJ et al
    J Vasc Surg Venous Lymphat Disord. 2018 Aug 18
     
  20. NewsBot

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    Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft.
    Bianchi C et al
    Int Wound J. 2019 Jun;16(3):761-767
     
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    Modified compression therapy in mixed arterial–venous leg ulcers: An integrative review
    Sheryl Li Xin Lim Rui En Chung Samantha Holloway Keith G. Harding
    18 March 2021 https://doi.org/10.1111/iwj.13585
     
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    Can Thermal Imaging Technique be Used to Predict the Healing Status of a Venous Leg Ulcer?
    Rajna Ogrin et al
    Int J Low Extrem Wounds. 2021 Apr 15
     
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    Extracellular matrix and cellular senescence in venous leg ulcers
    Debbie X E Lim et al
    Sci Rep. 2021 Oct 11;11(1):20168
     
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    A dual pressure indicator, two-layer compression system for treatment of venous leg ulcers: a review
    Hong Qian Tai et al
    J Wound Care. 2021 Dec 1;30(Sup12):S6-S12
     
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    Knowledge and teaching-learning methods regarding venous leg ulcers in nursing professionals and students: A scoping review
    Iván Durán-Sáenz et al
    Nurse Educ Pract. 2022 Jul 16;63:103414
     
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    News Release 9-Aug-2022
    Study identifies potential targets for treating venous ulcers
    A comprehensive atlas of microRNA and messenger RNA expression in healing and non-healing human wounds highlights possible new approaches for treating venous ulcers – a common type of chronic, non-healing wound.

    The study, which includes the first resource detailing the role of microRNAs in the wound-repair process, shows that aberrant levels of a trio of microRNAs may impair healing in venous ulcers. The findings suggest that drugs targeting these microRNAs could help facilitate healing in patients.

    Venous ulcers commonly occur in the legs, caused by poor blood flow. These painful and slow-to-heal lesions can significantly impair an individual’s mobility and quality of life. Previous research in animals has shown that persistent inflammation and insufficient cell growth and migration may contribute to the poor healing of these wounds, but few studies have looked at the role of gene regulation in these processes in humans.

    “MicroRNAs regulate hundreds of genes and play a crucial role in skin wound repair,” says co-first author Zhuang Liu, a postdoctoral researcher at the Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden. “But a limited amount of information about how microRNAs regulate gene expression in human wounds has hampered the identification of microRNAs that could be useful therapeutic targets.”

    To fill this gap, the team collected 20 wound tissue samples from healthy volunteers with healing wounds on their legs and patients with venous ulcers. The samples were taken at three different time points to track the healing process. The team then used RNA sequencing to compare the expression of microRNAs and other molecules, called messenger RNAs, in healing and non-healing wounds at these time points.

    They discovered that 22 microRNAs and 221 messenger RNAs were expressed at higher levels in venous ulcers than in healing wounds, while 10 microRNAs and 203 messenger RNAs were expressed at lower levels. They also found that 17 microRNAs with elevated or abnormally low levels in patients with venous ulcers target genes involved in the condition.

    Next, the researchers conducted a series of experiments on human skin cells, called keratinocytes, collected from another set of healthy volunteers and patients with venous ulcers. These experiments confirmed the abnormal expression of several of these microRNAs and their gene targets in wound healing.

    Finally, they demonstrated that the elevated expression of three microRNAs in particular – microRNA-34a, microRNA-424 and microRNA-516 – increased the inflammatory response, as well as slowed the growth of new cells and the migration of cells needed to help close a wound.

    “Our work opens the door to developing new treatments for venous ulcers that reduce the levels of this microRNA trio to help restore normal wound healing in patients,” says co-first author Letian Zhang, a PhD student at the Center for Molecular Medicine, Karolinska Institutet. “MicroRNA-targeting therapies could be more effective and have fewer side effects in patients than some existing therapies for venous ulcers.”

    Documenting the microRNAs at different time points in the healing process is particularly important, adds co-senior author Pehr Sommar, a senior physician at the Department of Plastic and Reconstructive Surgery, Karolinska University Hospital, Stockholm, Sweden. “Elevated microRNA expression might promote healing at one point in the process and hinder it at another, so timing will be essential for potential microRNA-targeting therapies,” he says. “But we first need more studies looking at microRNAs in individual skin cells to validate our findings before we can test the effectiveness of this approach in patients.”

    As part of their study, the team created a compendium of their findings and made it available online to help other researchers who study the wound-healing process. “We hope this resource will help scientists learn more about how microRNAs regulate tissue repair, as well as accelerate studies of potential microRNA-targeting wound treatments,” concludes co-senior author Ning Xu Landén, associate professor in experimental dermatology at the Department of Medicine Solna, Karolinska Institutet.

    The compendium is available to access at https://www.xulandenlab.com/humanwounds-mirna-mrna.
     
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    Effect of educational interventions on wound healing in patients with venous leg ulceration: A systematic review and meta-analysis
    Jasmin Bossert,Johannes A. Vey,Lars Piskorski,Thomas Fleischhauer,Sinclair Awounvo,Joachim Szecsenyi,Jonas Senft
    21 November 2022
     
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    Influence of Nutrition Status and Compression Therapy on Venous Ulcer Healing: A Systematic Review
    María Teresa García-Rodríguez et al
    Adv Skin Wound Care. 2023 Jan 1;36(1):45-53
     
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    Effectiveness of Topical Sucralfate in the Management of Diabetic Foot Ulcers: An Open-Labeled Randomized Study
    Neha Chatterjee et al
    Cureus. 2023 Apr 14;15(4):e37570
     
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    Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study)
    Lihong Chen et al
    Trials. 2023 Aug 2;24(1):491
     
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    First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers
    David M Fairlamb et al
    Int Wound J. 2024 Mar;21(3):e14805
     
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    The effectiveness of nursing interventions in adherence to self-care for preventing venous ulcer recurrence: A systematic literature review
    Filipe José Paulo Gomes, Maria Adriana Pereira Henriques, Cristina Lavareda Baixinho
    20 November 2023
     
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