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NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, Jun 3, 2015.

  1. NewsBot

    NewsBot The Admin that posts the news.

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    NorLeu3-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers.
    Rodgers KE, Bolton LL, Verco S, diZerega GS
    Adv Wound Care (New Rochelle). 2015 Jun 1;4(6):339-345.
     
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    Admin2 Administrator Staff Member

  3. NewsBot

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    Press Release:
    Derma Sciences Announces Publication in Advances in Wound Care
    Review of aclerastide clinical development program for the treatment of diabetic foot ulcers underscores potential as an effective pharmaceutical within a multi-billion dollar market
     
  4. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press release:
    Derma Sciences Announces Results of Futility Analyses for Phase 3 Clinical Trials of Aclerastide in Diabetic Foot Ulcer Healing
     
  5. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press Release:
    Findings from Multicenter Study Comparing Derma Sciences’ AMNIOEXCEL? Against Standard-of-Care for Treating Diabetic Foot Ulcers Published in WOUNDS, a Leading Peer-Reviewed Journal
     
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    A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer.
    Snyder RJ et al
    Wounds. 2016 Mar;28(3):70-77.
     
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    Press Release:
    AMNIOX Highlights Study Showing More Than Eighty Seven Percent of Patients With Diabetic Foot Ulcers Achieve Healing When Treated with NEOX? Wound Allograft
     
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    A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers
    William Tettelbach Shawn Cazzell Felix Sigal Joseph M. Caporusso Patrick S. Agnew Jason Hanft Cyaandi Dove
    Int W J: 24 September 2018
     
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    Press Release:
    MiMedx Publishes Positive Results From Clinical Study Of Human Umbilical Cord For Diabetic Foot Ulcers
    September 25, 2018 at 8:30 AM EDT

    Study Published in International Wound Journal Reported Statistically Significant Evidence of Healing Compared to Standardized Therapy (ST)
    - Intent-To-Treat (ITT) EpiCord®-Treated Patients = 70% vs ST 48%, p=0.0089
    - Per-Protocol EpiCord-Treated Patients = 81% vs ST 54%, p=0.0013


    MARIETTA, Ga., Sept. 25, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new clinical study has been published in the peer-reviewed International Wound Journal, which evaluated the safety and efficacy of using dehydrated human umbilical cord (dHUC - EpiCord) for chronic diabetic foot ulcers (DFUs).

    The paper is entitled "A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers" and was co-authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM; Jason Hanft, DPM; and Cyaandi Dove, DPM. The published article in the International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.13001.

    This multicenter randomized and controlled trial was conducted at 11 centers in the United States and 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 later became Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

    Clinical Study Design and Results
    This is the first published clinical study of dHUC tissue. The objective of the study was to determine the safety and effectiveness of dHUC as compared to standardized therapy with alginate wound dressings for chronic, non-healing DFUs.

    The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 155 patients were analyzed in the Intent-to-Treat (ITT) cohort. Patients were randomized in a 2:1 ratio to receive weekly application of dHUC (n=101) or standardized therapy with alginate dressings (n=54). A total of 134 patients completed the study Per-Protocol (Per-Protocol cohort).

    ITT analysis includes patients 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 included in the final analysis.

    In the current study on an ITT basis, 70% of patients who received weekly dHUC had complete healing by 12 weeks versus 48% of patients only receiving weekly standardized therapy (p=0.0089).

    For patients completing the study Per-Protocol, 81% of those who received weekly dHUC achieved complete healing by 12 weeks. In comparison, 54% of patients had complete healing in 12 weeks after receiving weekly standardized therapy (p=0.0013).

    About dHUC
    dHUC is a thick membrane derived from umbilical cord, the structure that protects the arteries and vein that carry essential nourishment and oxygenated blood to and from mother and fetus. dHUC is a minimally manipulated, dehydrated, non-viable cellular umbilical cord allograft intended for homologous use that provides a protective environment for the healing process.

    Umbilical cord consists of amniotic epithelium and Wharton's jelly containing an extracellular matrix composed of collagen, proteoglycans and hyaluronic acid. MiMedx processes dHUC using the PURION® Plus process, an approach that provides an easy-to-use allograft stored at ambient conditions.

    MiMedx currently markets dHUC as a Human Cellular and Tissue-based Product (HCT/P) under Section 361 of Food and Drug Administration regulations under the brand names EpiCord® and AmnioCord®. MiMedx manufactures its products according to current Good Tissue Practices (cGTP) standards, pursuant to 21 CFR 1271, an FDA regulation. The Company is also in compliance with the AATB's (American Association of Tissue Banks) 14th standard, of which MiMedx is a fully accredited member in good standing.

    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 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.
     

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