• 1

    Phillips CJ, Humphreys I, Fletcher J, et al.: Estimating the costs associated with the management of patients with chronic wounds using linked routine data. Int Wound J 13: 1193, 2016.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2

    Grothier L, Stephenson J: An audit to determine the clinical effectiveness of a pathway for managing wound infection. Wounds UK 11: 32, 2015.

    • Search Google Scholar
    • Export Citation
  • 3

    Prompers L, Huijberts M, Apelqvist J, et al.: High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe: baseline results from the Eurodiale study. Diabetologia 50: 18, 2007.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4

    Kalan L, Loesche M, Hodkinson BP, et al.: Redefining the chronic-wound microbiome: fungal communities are prevalent, dynamic, and associated with delayed healing. mBio 7: e01058-16, 2016.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5

    Glaudemans AW, Uçkay I, Lipsky BA: Challenges in diagnosing infection in the diabetic foot. Diabet Med 32: 748, 2015.

  • 6

    O'meara S, Nelson EA, Golder S, et al.: Systematic review of methods to diagnose infection in foot ulcers in diabetes. Diabet Med 23: 341, 2006.

  • 7

    Surgical site infections: prevention and management. NICE Web site. Available at: https://www.nice.org.uk/guidance/ng125. Accessed August 6, 2020.

    • Search Google Scholar
    • Export Citation
  • 8

    Gardner SE, Haleem A, Jao YL, et al.: Cultures of diabetic foot ulcers without clinical signs of infection do not predict outcomes. Diabetes Care 37: 2693, 2014.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 9

    Diabetic foot problems: prevention and management. NICE Web site. Available at: https://www.nice.org.uk/guidance/ng19. Accessed August 6, 2020.

    • Search Google Scholar
    • Export Citation
  • 10

    Pichu S, Patel BM, Apparsundaram S, et al.: Role of biomarkers in predicting diabetes complications with special reference to diabetic foot ulcers. Biomark Med 11: 377, 2017.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Spichler A, Hurwitz BL, Armstrong DG, et al.: Microbiology of diabetic foot infections: from Louis Pasteur to “crime scene investigation.” BMC Med 13: 2, 2015.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 12

    Läuchli S, Swanson T, Serena T, et al.: The use of a point-of-care test for bacterial protease activity in chronic wounds. Wounds Int 6: 22, 2015.

    • Search Google Scholar
    • Export Citation
  • 13

    Tegl G, Schiffer D, Sigl E, et al.: Biomarkers for infection: enzymes, microbes, and metabolites. Appl Microbiol Biotechnol 99: 4595, 2015.

  • 14

    Jonker L, Smith D, Mark E, et al.: Point-of-care testing for bacterial infection in diabetic foot ulcers: a prospective cohort study. J Wound Care 29: 649, 2020.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Gardner SE, Frantz RA, Doebbeling BN: The validity of the clinical signs and symptoms used to identify localized chronic wound infection. Wound Repair Regen 9: 178, 2001.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Bowler PG, Duerden BI, Armstrong DG: Wound microbiology and associated approaches to wound management. Clin Microbiol Rev 14: 244, 2001.

  • 17

    Levine NS, Lindberg RB, Mason AD Jr, et al.: The quantitative swab culture and smear: a quick, simple method for determining the number of viable aerobic bacteria on open wounds. J Trauma 16: 89, 1976.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18

    SMI. UK Standards for Microbiology Investigations: investigation of swabs from skin and superficial soft tissue infections. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/766634/B_11i6.5.pdf.

    • Search Google Scholar
    • Export Citation
  • 19

    Healy B, Freedman A: ABC of wound healing: infections. BMJ 332: 838, 2006.

  • 20

    Herdman M, Gudex C, Lloyd A, et al.: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 20: 1727, 2011.

  • 21

    Tabachnick B, Fidell L: “Principal Components and Factor Analysis,” in Using Multivariate Statistics, 6th Ed, Pearson, London, 2014.

    • Search Google Scholar
    • Export Citation
  • 22

    Reddy M, Gill SS, Wu W, et al.: Does this patient have an infection of a chronic wound? JAMA 307: 605, 2012.

  • 23

    Heinzle A, Papen‐Botterhuis NE, Schiffer D, et al.: Novel protease‐based diagnostic devices for detection of wound infection. Wound Repair Regen 21: 482, 2013.

  • 24

    Glucksman M, Philibert K, Shao X, et al.: ‘Ome is where the wound is: biomarkers of healing in chronic diabetic foot ulcers. FASEB J 31(1_supplement):780, 2017.

    • Search Google Scholar
    • Export Citation
  • 25

    Nedeva C, Menassa JA, Puthalakath H: Sepsis: inflammation is a necessary evil. Frontiers Cell Dev Biol 7: 108, 2019.

  • 26

    Lipsky BA, Aragon-Sanchez J, Diggle M, et al.: IWGDF guidance on the diagnosis and management of foot infections in persons with diabetes. Diabetes Metab Res Rev 32(suppl 1): 45, 2016.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Umemneku Chikere CM, Wilson K, Graziadio S, et al.: Diagnostic test evaluation methodology: a systematic review of methods employed to evaluate diagnostic tests in the absence of gold standard—an update. PLoS One 14: e0223832, 2019.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 28

    Jia L, Parker CN, Parker TJ, et al.; Diabetic Foot Working Group, Queensland Statewide Diabetes Clinical Network (Australia): Incidence and risk factors for developing infection in patients presenting with uninfected diabetic foot ulcers. PLoS One 12: e0177916, 2017.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Lavery LA, Armstrong DG, Wunderlich RP, et al.: Risk factors for foot infections in individuals with diabetes. Diabetes Care 29: 1288, 2006.

  • 30

    Boykin J Jr: The future of wound care diagnostics: biomarkers. Ostomy Wound Manage 55: 20, 2009.

  • 31

    Price CP: Point of care testing. BMJ 322: 1285, 2001.

Evaluation of Glycologic Point-of-Care Infection Test Kit for Diabetic Foot Ulcers in Relation to Bacterial Presence: A Prospective Cohort Study

View More View Less
  • 1 North Cumbria Integrated Care NHS Foundation Trust, Carlisle, England.
Restricted access

Background: Point-of-care testing for infection might help podiatric physicians optimize management of diabetic foot ulcers (DFUs). Glycologic’s proprietary GLYWD product has been developed to detect changes in a patient’s immunologic/inflammatory response related to wound infection. We evaluated how bacterial presence in DFUs relates to GLYWD test outcome.

Methods: This was a single-organization, prospective, controlled cohort study of clinical opinion versus GLYWD test result for DFU infection status and the appraisal of bacterial presence in the wounds and semiquantitative microbiology swab at weeks 0, 3, 6, 12, and 18. Spearman correlation, backward elimination linear regression, and principal components analysis were applied to determine which variables, including degree of bacterial load, are associated with a positive clinical opinion or GLYWD result for DFU infection.

Results: Forty-eight patients were enrolled, and 142 complete wound appraisals were conducted; a consensus outcome between clinical opinion and GLYWD result was achieved in most (n = 122, 86%). Clinical opinion significantly correlated with a higher bacterial load (Spearman rho = 0.38; P < .01), whereas GLYWD did not (rho = –0.010; P = .91). This observation was corroborated with logistic regression analysis, in which a previous observation of both clinical opinion and GLYWD associating with wound purulence and erythema was also confirmed.

Conclusions: Podiatric physicians are guided by hallmark signs of DFU infection, such as erythema and purulence; furthermore, we found that clinical opinion of infection correlates with increased bacterial load. GLYWD test results match clinical opinion in most cases, although the results obtained with this point-of-care method suggest that the degree of bacterial presence might not necessarily mean a higher chance of inducing an immunologic/inflammatory host response to said bacteria.

Corresponding author: Leon Jonker, PhD, Science and Innovation Manager, North Cumbria Integrated Care NHS Foundation Trust, Carlisle, CA1 3SX, UK. (E-mail: leon.jonker@ncic.nhs.uk)