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Incoherent optical fluctuation flowmetry for detecting limbs with hemodynamically significant stenoses in patients with type 2 diabetes

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Abstract

Introduction

The development of new highly accurate, inexpensive and accessible methods for the detection of lower-extremity peripheral artery disease (LE-PAD) in diabetic patients is required. The aim of this study was to evaluate the accuracy of a new incoherent optical fluctuation flowmetry (IOFF) method in detecting legs with hemodynamically significant stenoses compared to ankle brachial index (ABI) and transcutaneous oximetry (TcPO2) in patients with diabetes mellitus (DM).

Materials and methods

Patients were recruited into 2 groups. Group 1 included patients with DM without LE-PAD and/or diabetic foot syndrome; Group 2 included patients with DM and LE-PAD. All patients underwent the following measurements: ultrasound (reference method), ABI, TcPO2, and the new IOFF method.

Results

The new IOFF method showed a sensitivity of 79.5% and a specificity of 89.8% in detecting limbs with hemodynamically significant stenosis (AUC 0.890, CI 0.822–0.957). TcpO2 allows the diagnosis of LE-PAD with 69.2% sensitivity and 86.2% specificity (AUC 0.817, CI 0.723–0.911). Using a standard ABI cut-off of less than 0.9, the sensitivity and specificity for this parameter were 34.5% and 89.7%, respectively. Increasing the diagnostic cut-off of the ABI on the study group to 0.99 improved sensitivity to 84.6% and specificity to 78% (AUC,0.824 CI 0.732–0.915).

Conclusions

The new IOFF technique has demonstrated high sensitivity and specificity in the detection of LE-PAD in patients with DM. The high accuracy, rapid measurement, and potential availability suggest that the new IOFF method has a high potential for clinical application in the detection of PAD.

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Data availability

Data are available from the corresponding author (P.G.) upon reasonable request.

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Acknowledgements

We sincerely thank the reviewer who worked with our article. The deep and substantiated recommendations of the reviewer allowed us not only to refine the article, but also influenced the further research plans of our scientific group.

Funding

Patient recruitment and examination were funded by JSC “Elatma Instrument-Making Enterprise” (Ryazan, Russia). Data analysis and interpretation were performed by researchers without funding from JSC “Elatma Instrument-Making Enterprise” as part of the research project “New Approaches to the Comprehensive Assessment of Peripheral Hemodynamic Parameters in the Management of Patients with Diseases of Various Etiologies”, funded by the State Budget of the Moscow Region. The funding source had no role in this manuscript.

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Authors and Affiliations

  1. Moscow Regional Research and Clinical Institute (“MONIKI”), Moscow, Russia

    Polina Glazkova, Alexey Glazkov, Denis Lapitan, Sergei Zagarov, Roman Larkov, Yulia Kovaleva, Natalia Mazur, Timur Britvin & Dmitry Rogatkin

  2. Medical Faculty, State University of Education, Mytishchi, Russia

    Dmitry Kulikov

  3. N.A. Semashko National Research Institute of Public Health, Moscow, Russia

    Dmitry Kulikov

  4. Almazov National Medical Research Centre, St. Petersburg, Russia

    Alina Babenko, Yulia Kononova & Elena Kitaeva

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  1. Polina Glazkova
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Contributions

Conceptualization: P.G., D.R., A.G.; Methodology: P.G., D.R., A.G., D.K., D.L., A.B.; Software: D.L.; Formal analysis: A.G.; Investigation: P.G., A.G., S.Z., R.L., A.B.,Yu Kon, Yu Kov, E.K., N.M., T.B.; Resources D.R., R.L., A.B., T.B., D.K.; Writing – original draft preparation: P.G.; Writing – review and editing: all authors; Visualization: P.G., A.G.; Supervision: D.R., D.K.; Project administration: D.R., D.K., P.G., A.G. All authors have read, and agreed to the published version of the manuscript.

Corresponding author

Correspondence to Polina Glazkova.

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Conflict of interest

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethical approval and consent to participate

Written informed consent was obtained from each patient. The study protocol was approved by the research ethics committees of the participating institutions: Moscow Regional Research and Clinical Institute Independent Ethics Committee (Protocol No. 13, dated 7 November 2019); Almazov National Medical Research Centre Ethics Committee (No. 27112019, meeting No. 11–19, dated 11 November 2019). The principles of the Declaration of Helsinki were followed.

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Appendix

Appendix

Tables 5, 6

Table 5 Comparison of hemodynamic parameters in limbs with and without ulcers in group 2
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Table 6 Correlation coefficient between blood flow parameters and a number of stenoses
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Glazkova, P., Glazkov, A., Kulikov, D. et al. Incoherent optical fluctuation flowmetry for detecting limbs with hemodynamically significant stenoses in patients with type 2 diabetes. Endocrine 82, 550–559 (2023). https://doi.org/10.1007/s12020-023-03506-4

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