EP2745116A2 - Pronostic d'une plaie - Google Patents

Pronostic d'une plaie

Info

Publication number
EP2745116A2
EP2745116A2 EP12762381.7A EP12762381A EP2745116A2 EP 2745116 A2 EP2745116 A2 EP 2745116A2 EP 12762381 A EP12762381 A EP 12762381A EP 2745116 A2 EP2745116 A2 EP 2745116A2
Authority
EP
European Patent Office
Prior art keywords
wound
mmp
healing
sample
hne
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12762381.7A
Other languages
German (de)
English (en)
Inventor
Simon William Bayliff
Breda Mary Cullen
Molly GIBSON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Woundchek Laboratories BV
Original Assignee
Woundchek Laboratories BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Woundchek Laboratories BV filed Critical Woundchek Laboratories BV
Publication of EP2745116A2 publication Critical patent/EP2745116A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6881—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from skin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
    • G01N2333/95—Proteinases, i.e. endopeptidases (3.4.21-3.4.99)
    • G01N2333/964—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue
    • G01N2333/96425—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals
    • G01N2333/96427—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general
    • G01N2333/9643—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general with EC number
    • G01N2333/96486—Metalloendopeptidases (3.4.24)
    • G01N2333/96491—Metalloendopeptidases (3.4.24) with definite EC number
    • G01N2333/96494—Matrix metalloproteases, e. g. 3.4.24.7
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
    • G01N2333/966—Elastase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/20—Dermatological disorders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

Definitions

  • the present invention relates to methods and devices for determining the healing status of wounds, in particular of chronic wounds. Also provided are kits comprising the diagnostic devices, and methods of wound diagnosis and treatment using the diagnostic devices and methods.
  • the word 'chronic 5 is a generic term used to describe a condition that is Of long duration' or that 'recurs frequently'. It is for tliis reason it is used to describe wounds that are difficult to heal and usually persist for a long period of time. Thus, while all wounds have the potential to become chronic, traditionally chronic wounds are identified by their underlying aetiology such as venous insufficiency, arterial perfusion, diabetes, or unrelieved pressure as well as systemic factors such as nutritional status, immunosuppression, and infection all of which may contribute to poor wound healing.
  • the present invention further provides a device for use in a method of wound prognosis comprising the steps of: determining a weighted average (weighted sum) of the levels of human neutrophil elastase (hNE) and at least one matrix metalloprotemase (MMP) in a sample of wound fluid from a wound; and assigning said wound to a non-healing category if said weighted average (weighted sum) exceeds a threshold value.
  • hNE human neutrophil elastase
  • MMP matrix metalloprotemase
  • the methods of the present invention may further comprise the step of determining said threshold value(s).
  • the level of elastase may be indicated by total elastase- like activity, for example by measuring the rate of cleavage of a substrate for the hNE enzyme.
  • the present invention provides a diagnostic kit comprising a diagnostic device according to any preceding aspect or embodiment, together with one or more of: a color chart for interpreting the output of the diagnostic device, a sampling device for collecting a sample of a biological fluid such as a wound fluid; a wash liquid for carrying a sample of fluid through the device, and a pretreatment solution containing a reagent for pretreatment of the fluid sample.
  • the term "predetermined threshold” refers to a minimum level that the skilled person would detennine is indicative of a non-healing wound based on statistical analysis of levels determined for known healing and non-healing wounds, for example as explained further below.
  • the threshold should be set at an appropriate level so that non-healing wounds with high protease activity are coixectly identified. Increasing the threshold will increase the chance of only non-healing wounds being over the threshold. However, if the threshold is too high, wounds that are non-healing due to a Mgh level of proteases would not be identified and clinically this would mean they would not receive the required protease modulating treatment.
  • hNE activity was measured spectrophotometrically using a substrate which mimics the cleavage site of the enzyme.
  • the substrate sequence used was specific for neutrophil derived elastase; MeOSuc-Alanine-Alanine-Proline- Valine- 7 amino 4 methyl coumarin (Bachem, Switzerland) (SEQ ID NO: 7).
  • This short peptide substrate also contains the fluorescent reporter group, 7-amino 4-methyl coumarin, which is released upon substrate hydrolysis.
  • Enzyme activity was then calculated by measuring the rate of production of the fluorimetrie compound at 450nm (excitation 380nm). Activity was expressed as relative fluorescence units per minute and converted to milliunits of elastase activity per minute per 110 ,uL swab extract (mU/min/l ⁇ ,) from a standard curve.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention concerne un procédé d'établissement d'un pronostic pour une plaie, ledit procédé comprenant les étapes consistant à : déterminer si un niveau moyen pondéré d'élastase neutrophile humaine (hNE) et d'une ou plusieurs métalloprotéinases matricielles (MMP) dans un échantillon d'un exsudat de plaie est supérieur à une valeur seuil prédéterminée pour ladite moyenne pondérée ; et placer ladite plaie dans une catégorie plaie qui ne cicatrise pas si ladite moyenne pondérée excède ladite valeur seuil prédéterminée pour ladite moyenne pondérée. La présente invention concerne en outre des dispositifs pour la mise en œuvre du procédé.
EP12762381.7A 2011-09-23 2012-09-21 Pronostic d'une plaie Withdrawn EP2745116A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1116523.0A GB201116523D0 (en) 2011-09-23 2011-09-23 Wound prognosis
GB1118119.5A GB2494934A (en) 2011-09-23 2011-10-20 Wound prognosis
PCT/GB2012/052345 WO2013041879A2 (fr) 2011-09-23 2012-09-21 Pronostic d'une plaie

Publications (1)

Publication Number Publication Date
EP2745116A2 true EP2745116A2 (fr) 2014-06-25

Family

ID=44993342

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12762381.7A Withdrawn EP2745116A2 (fr) 2011-09-23 2012-09-21 Pronostic d'une plaie

Country Status (3)

Country Link
EP (1) EP2745116A2 (fr)
GB (2) GB201116523D0 (fr)
WO (1) WO2013041879A2 (fr)

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658592A (en) 1994-05-13 1997-08-19 Kuraray Co., Ltd. Medical crosslinked polymer gel of carboxylic polysaccharide and diaminoalkane
GB2314842B (en) 1996-06-28 2001-01-17 Johnson & Johnson Medical Collagen-oxidized regenerated cellulose complexes
US6309454B1 (en) 2000-05-12 2001-10-30 Johnson & Johnson Medical Limited Freeze-dried composite materials and processes for the production thereof
GB2381452B (en) * 2001-11-05 2005-08-10 Johnson & Johnson Medical Ltd Wound monitoring
AU2002359529B2 (en) * 2001-11-29 2008-02-21 Greystone Medical Group, Inc. Treatment of wounds and compositions employed
US20030119073A1 (en) * 2001-12-21 2003-06-26 Stephen Quirk Sensors and methods of detection for proteinase enzymes
JP2005528887A (ja) 2002-01-31 2005-09-29 エクスプレッシブ コンストラクツ，インコーポレイテッド 微生物の検出方法
DK1536845T3 (da) 2002-09-11 2007-06-11 Johnson & Johnson Medical Ltd Sårforbindingsmaterialer indeholdende komplekser af anioniske polysaccharider med sölv
GB2393120A (en) 2002-09-18 2004-03-24 Johnson & Johnson Medical Ltd Compositions for wound treatment
ES2357547T3 (es) 2003-09-02 2011-04-27 Systagenix Wound Management Ip Co. Bv. Amplificación de señal usando un zimogeno sintético.
GB2422664A (en) * 2005-01-28 2006-08-02 Ethicon Inc Device for detecting an enzyme in a sample
GB2418145A (en) * 2004-09-17 2006-03-22 Ethicon Inc Wound treatment system
US20070142762A1 (en) * 2005-12-16 2007-06-21 Eastman Kodak Company Wound dressing
GB2437311A (en) 2006-04-07 2007-10-24 Mologic Ltd A protease detection product
CA2671872A1 (fr) * 2006-12-07 2008-06-12 University Of Florida Research Foundation, Inc. Materiaux et methodes pour detecter efficacement et precisement des analytes
GB2452076A (en) 2007-08-23 2009-02-25 Mologic Ltd Detection of enzymes by detecting binding of substrate recognition molecules to modified substrates
GB2454672A (en) 2007-11-13 2009-05-20 Mologic Ltd Chromogenic protease substrates
WO2010022281A1 (fr) * 2008-08-20 2010-02-25 Greystone Pharmaceuticals, Inc. Procédés d'utilisation d'élastase neutrophile humaine en tant qu'indicateur d'infection de plaie active
CA2764775C (fr) * 2009-06-26 2019-02-26 University Of Florida Research Foundation, Inc. Mesure rapide au lit du malade de l'activite elastasique des neutrophiles dans des liquides biologiques
GB2487729A (en) * 2011-01-31 2012-08-08 Systagenix Wound Man Ip Co Bv Measurement of matrix metalloproteinase (MMP) and elastase in wound fluid
EP2671081A2 (fr) * 2011-01-31 2013-12-11 Systagenix Wound Management IP Co. BV. Pronostic de plaie

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2013041879A2 *

Also Published As

Publication number Publication date
GB201116523D0 (en) 2011-11-09
GB201118119D0 (en) 2011-11-30
WO2013041879A2 (fr) 2013-03-28
WO2013041879A3 (fr) 2013-05-30
GB2494934A (en) 2013-03-27

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