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NPWT in diabetic foot wounds—a systematic review and meta-analysis of observational studies

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Abstract

Purpose

Negative-pressure wound therapy (NPWT) is an adjunct modality in diabetic foot ulcerations (DFUs). Randomized controlled trials (RCTs) have shown its advantage over standard approaches; however, data from observational studies remain scarce.We performed a systematic review of observational non-RCTs evaluating NPWT efficacy and safety in patients with DFU.

Methods

Electronic databases were searched for observational studies involving NPWT. The results of single-arm studies were presented as percentages of patients with the outcome of interest. A meta-analysis of comparative studies provided point estimates of outcomes. Continuous outcomes were reported as either weighted or standardized mean differences and dichotomous data as relative risks (RR).

Results

The search identified 16 relevant observational studies, 12 single-arm, and 4 comparative, reporting on a total of 18,449 patients with DFU, of whom 1882 were managed with NPWT. In the NPWT-treated patients, ulcers were larger (average size range 6.6–27.9 cm2), as compared with controls (≤3 cm2). The pooled results showed healing and major amputation in 51% and 5% of NPWT patients, respectively. The meta-analysis of comparative studies revealed lower risk of major amputation [RR = 0.23 (0.07; 0.80)] in NPWT-treated patients. The pooled results for healing rate and risk of any amputation were inconclusive due to large between-study heterogeneity. Overall, 6 deaths out of 158 patients were reported, none of them related to NPWT. Serious adverse events occurred in 6% of patients on NPWT.

Conclusions

This systematic review of observational studies provided supportive evidence that NWPT is an efficient and safe adjunct treatment in the management of DFUs.

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Funding

The study was funded by the National Science Centre in Poland through the Opus Grant “Assessment of molecular mechanisms of NPWT in the treatment of neuropathic ulceration in DFS” to MTM (Nr 2013/11/B/NZ5/03298).

Author contributions

Study design, protocol development: PR, MTM; searching medical databases: PR, MM, AZ; data analysis: PR, AZ, MM; research data, data interpretation: SB, JH, MT, PR, AZ, BKW; writing the manuscript: MTM, PR; critical review of the manuscript: SB, JH; project coordination, final approval of the manuscript: PR, MTM; MTM and PR are the guarantors of the data and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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Authors and Affiliations

  1. HTA Consulting, Krakow, Poland

    Przemyslaw Rys, Aleksandra Zapala & Magdalena Monica

  2. Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland

    Sebastian Borys, Jerzy Hohendorff, Przemyslaw Witek, Beata Kiec-Wilk & Maciej T. Malecki

  3. Department of Metabolic Diseases, University Hospital in Krakow, Krakow, Poland

    Sebastian Borys, Jerzy Hohendorff, Przemyslaw Witek, Beata Kiec-Wilk & Maciej T. Malecki

  4. Faculty of Medicine, University of Toronto, Toronto, ON, Canada

    Claudia Frankfurter

  5. Center for Medical Genomics OMICRON, Jagiellonian University Medical College, Krakow, Poland

    Agnieszka Ludwig-Slomczynska

Authors
  1. Przemyslaw Rys
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  2. Sebastian Borys
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  3. Jerzy Hohendorff
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  6. Magdalena Monica
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  9. Beata Kiec-Wilk
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  10. Maciej T. Malecki
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Correspondence to Maciej T. Malecki.

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Rys, P., Borys, S., Hohendorff, J. et al. NPWT in diabetic foot wounds—a systematic review and meta-analysis of observational studies. Endocrine 68, 44–55 (2020). https://doi.org/10.1007/s12020-019-02164-9

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  • DOI: https://doi.org/10.1007/s12020-019-02164-9

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