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A randomized, open-label, controlled trial to evaluate the antimicrobial and surgical effect of CO2 laser treatment in diabetic infected foot ulcers: DULCIS (diabetic ulcer, CO2 laser, and infections) study

Abstract

Aim

Debridement of fibrin and necrotic tissue from the ulcer surface is an important component of the treatment of diabetic ulcers. A possible alternative to standard lancets is represented by CO2 laser, which vaporizes necrotic tissues together with any pathogen. The present trial is aimed at verifying the effect of a CO2 laser on bacterial load in the debridement of infected diabetic foot ulcers.

Methods

In this open-label randomized controlled trial (NCT02677779), patients with diabetes and an infected foot ulcers were randomized to either CO2 laser or traditional debridement.

Results

The reduction (%) of bacterial load with CO2 laser was significantly greater than in control group [−99.9 (−100.0; −90.0) vs. −50.0 (−96.0; −75.0), p = 0.049]. Similarly, a significantly greater reduction (%) of the fraction of ulcer area covered by fibrin was obtained in the intervention group [−84.1 (−95.0; −72.2) vs. −46.9 (−69.5; −40.8), p = 0.038].

Conclusions

Debridement of ulcers with CO2 laser significantly reduces bacterial load and fibrin-covered areas, and could be of help in the treatment of diabetic foot ulcer.

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Author contribution

MM and EM wrote the manuscript and enrolled patients. SA enrolled patients and reviewed the manuscript. CM and AS reviewed/edited the manuscript and contributed to the discussion. SZ contributed to the discussion and enrolled patients. LG contributed to discussion, enrolled patients, and reviewed the manuscript. MM is the guarantor of this work 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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Correspondence to M. Monami.

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Funding

This study was sponsored by DEKA S.p.a., Calenzano-Florence, Italy.

Conflict of interest

All other authors have no relevant conflict of interest to disclose.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Human and animal rights

This article does not contain any studies with animals performed by any of the authors.

Informed consent

A formal informed consent was obtained for all participants.

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Monami, M., Scatena, A., Zannoni, S. et al. A randomized, open-label, controlled trial to evaluate the antimicrobial and surgical effect of CO2 laser treatment in diabetic infected foot ulcers: DULCIS (diabetic ulcer, CO2 laser, and infections) study. J Endocrinol Invest 40, 985–989 (2017). https://doi.org/10.1007/s40618-017-0666-2

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  • DOI: https://doi.org/10.1007/s40618-017-0666-2

Keywords

  • Randomized trial
  • Type 2 diabetes
  • Foot ulcer
  • CO2 laser