A randomized, open-label, controlled trial to evaluate the antimicrobial and surgical effect of CO 2 laser treatment in diabetic infected foot ulcers: DULCIS (diabetic ulcer, CO 2 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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