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EpiFix for diabetic foot ulcers

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, Aug 8, 2012.

  1. NewsBot

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    Press Release:
    MiMedx® Group Announces Positive Results From Diabetic Foot Ulcer Randomized Controlled Trial
     
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  3. NewsBot

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    A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.
    Zelen CM, Serena TE, Denoziere G, Fetterolf DE.
    Int Wound J. 2013 Jun 7.
     
  5. NewsBot

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    Press Release:
    Poster on MiMedx EpiFix® Receives Highest Score at the Symposium on Advanced Wound Care (SAWC)
    EpiFix® is the subject of six poster abstracts accepted at SAWC
     
  6. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs.
    Zelen CM.
    J Wound Care. 2013 Jul;22(7):347-8, 350-1.
     
  7. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    MiMedx Follow Up Study Of DFU Patients Shows 94% Of Patients Remained Healed After Nine To Twelve Months
     
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    A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers
    Charles M Zelen, Thomas E Serena, Robert J Snyder
    International Wound Journal; Early View
     
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    A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix®) allograft for the treatment of venous leg ulcers
    Christian Bianchi, et al
    International Wound Journal 11 October 2017
     
  10. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    Multicenter Randomized Controlled VLU Clinical Study Published in the International Wound Journal Demonstrates Significantly Higher Healing Rates of MiMedx EpiFix®
    MIMEDX REITERATES ITS EXPECTATION FOR THIS STUDY TO EXPAND THE COMPANY'S VLU INSURANCE COVERAGE BY AN ADDITIONAL $75 MILLION TO $150 MILLION ANNUAL REVENUE OPPORTUNITY
    MIMEDX EPIFIX SHOWED VLU HEALING RATES OF 60% AT 12 WEEKS AND 71% AT 16 WEEKS

    MARIETTA, Ga., Oct. 11, 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 the latest peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been published 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 can be found at http://onlinelibrary.wiley.com/doi/10.1111/iwj.12843/epdf.

    Venous leg ulcers (VLUs) affect over two million people annually in the United States and cause significant clinical and economic consequences on society. VLUs are often marked by a significant level of chronicity and may require many months of treatment before a satisfactory level of healing is achieved. Even once healed, recurrence of a VLU is common. Slow rates of healing and frequent recurrence result in prolonged disability and the need for repetitive care, which compounds the psychosocial issues and economic burdens associated with the condition. In the United States, the estimated payer burden associated with treatment of VLUs was near $15 billion in 2014, and this number is only expected to rise.

    The study was a 16 week randomized, fifteen-center, clinical trial conducted to evaluate the efficacy of EpiFix as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. Subjects (n=109) were randomized to receive EpiFix in addition to moist dressings and compression (n=52) or moist dressings and compression alone (n=57). The primary endpoint of the study was time to complete wound closure, as assessed over a 12 week period from treatment initiation. Secondary endpoints included the proportion of subjects with complete wound closure by 12 and 16 weeks. Complete healing of the study ulcer was defined as 100% re-epithelialization without drainage.

    Parker H. Petit, Chairman and CEO, stated, "This is a significant study that offers the most important data generated for VLU patients and their caregivers in the last 20 years. EpiFix is the first and only placental-based allograft to show clinical superiority over multilayer compression therapy in a multi-center, randomized, prospective clinical study."

    Bill Taylor, President and COO, noted, "The rapid and complete healing is the primary goal when treating a VLU. The longer it takes to heal an ulcer, the greater the financial burdens to the healthcare system. Moreover, the longer length of healing causes significant financial burden on the patient and family as well as encumbrances in quality of life and other personal burdens for the patient. Unfortunately, less than 50% of VLUs heal within three months with standard treatment of debridement, wound dressings and aggressive compression therapy. When first line treatments fail, more advanced therapies should be used."

    In the Company's earlier press release of August 31, 2017, MiMedx confirmed the impressive results of this study. The study results indicate that:

    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.
    EpiFix showed clinical superiority over Standard of Care (SOC) in the treatment of non-healing, full thickness VLUs. Wounds treated with EpiFix were 2.26 times more likely to heal within 12 weeks than wounds treated with standard care alone.
    Results of this study 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.
    "When comparing individual 12-week VLU clinical trial results of Apligraf, the other biologically active product with next largest market share behind our EpiFix allograft, EpiFix shows by far the highest percentage of patients healed in 12 weeks. Compared to the superior 60% healing rate of EpiFix, it took Apligraf twice as long to heal 45% of wounds at 24 weeks. Additionally, in the Apligraf study, significantly smaller wounds were treated, and the study excluded patients with difficult medical conditions that were included in the EpiFix study," said Petit.

    Taylor added, "With only about 30% of the commercial plans that cover EpiFix for Diabetic Foot Ulcers (DFUs) also covering EpiFix for VLUs, we expect this study will dramatically increase that ratio. We look forward to working with those commercial health plans to gain EpiFix coverage for VLUs. Conservatively, we expect our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance to be between approximately $75 million and $150 million."

    Petit commented, "We have demonstrated in several peer-reviewed publications that our PURION® Processed dHACM recruits stem cells, promotes migration, and modulates stem cell activity in vitro and in vivo compared to appropriate controls. Numerous randomized controlled clinical trials have demonstrated that our PURION Processed dHACM is an effective therapy for treatment of chronic wounds and to promote soft tissue healing. In addition, MiMedx's dHACM allografts are now described in an official U.S. Pharmacopeia – National Formulary monograph with the publication of USP 40 - NF 35. We believe no other competitor can come close to this level of accomplishment, nor can their and products compare with the clinical and economic effectiveness of our dHACM allografts."

    Apligraf® is federally registered trademark of Organogenesis Inc. Use of this marks in this press release does not imply any affiliation with or endorsement by the trademark holder.

    About MiMedx
    MiMedx is 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. "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.
     
  11. NewsBot

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    Articles:
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    Use of Dehydrated Human Amnion/Chorion Membrane Allografts in More Than 100 Patients with Six Major Types of Refractory Nonhealing Wounds.
    Matthew Garoufalis, Darshan Nagesh, Patrick J. Sanchez, Robin Lenz, Sarah J. Park, Jake G. Ruff, Anna Tien, Justin Goldsmith, and Andrea Seat
    Journal of the American Podiatric Medical Association: March 2018, Vol. 108, No. 2, pp. 84-89.
     
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    Articles:
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    Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi‐centre clinical trial in 80 patients
    Lawrence A DiDomenico Dennis P Orgill Robert D Galiano Thomas E Serena Marissa J Carter Jarrod P Kaufman Nathan J Young Allen M Jacobs Charles M Zelen
    Int W J: 17 July 2018
     
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    A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics
    William Tettelbach Shawn Cazzell Alexander M Reyzelman Felix Sigal Joseph M Caporusso Patrick S Agnew
    Int W Journal: 22 August 2018
     
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    MiMedx Announces Statistically Significant Results In New Multicenter Clinical Study Of Healing Of Diabetic Foot Ulcers Using EpiFix®
    - Study Published in International Wound Journal Reported Statistically Significant Evidence of Healing Compared to Control Group
    - Intent-To-Treat EpiFix Treated Patients = 70% vs Control 50%, p=0.0338
    - Per-Protocol EpiFix Treated Patients = 81% vs Control 55%, p=0.0093

    MARIETTA, Ga., Aug. 24, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new study regarding the use of EpiFix® in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

    The paper is entitled "A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics." The paper was authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM. The electronic publication of the article in International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.12976.

    This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Dr. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

    Clinical Study Design and Results

    The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).

    ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.

    In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338).

    For patients completing the study per protocol, 81% of those who received weekly EpiFix treatments achieved complete healing by 12 weeks. In comparison, 55% of patients had complete healing in 12 weeks after receiving weekly SOC alone (EpiFix + SOC 81% vs. SOC 55%, p=0.0093).

    In the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with EpiFix were more than twice as likely to heal completely within 12 weeks as those not receiving EpiFix (HR: 2.15, 95% confidence interval 1.30-3.57, p=0.003).

    Mechanism of Action
    EpiFix® is a tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM). The Company's published scientific work indicates that MiMedx dHACM retains a diverse array of regulatory proteins including essential growth factors, cytokines and chemokines, which are regulators in inflammation, wound repair and tissue regeneration.

    About MiMedx
    MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind the Company's mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million 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.
     
  15. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: A trial-based health economics study
    Marissa J Carter
    J Med Econ. 2020 Jul 30;1.
     
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