title: A randomized, open-label, controlled trial to evaluate the antimicrobial and surgical effect of CO2laser treatment in diabetic infected foot ulcers: DULCIS (diabetic ulcer, CO2laser, and infections) study.
abstract: OBJECTIVE
  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 CO2laser, which vaporizes necrotic tissues together with any pathogen. The present trial is aimed at verifying the effect of a CO2laser 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 CO2laser or traditional debridement.
  
  
  RESULTS
  The reduction (%) of bacterial load with CO2laser 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 CO2laser significantly reduces bacterial load and fibrin-covered areas, and could be of help in the treatment of diabetic foot ulcer.
authors.affiliation: Diabetic Foot Unit, SOD Diabetologia-Azienda Ospedaliero Universitaria Careggi, Via delle Oblate n. 4, 50141, Florence, Italy. matteo.monami@unifi.it.
authors.forename: M
authors.initials: M
authors.lastname: Monami
authors.affiliation: Diabetology Unit, San Donato Hospital, Arezzo, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Scatena
authors.affiliation: Diabetic Foot Unit, SOD Diabetologia-Azienda Ospedaliero Universitaria Careggi, Via delle Oblate n. 4, 50141, Florence, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Zannoni
authors.affiliation: Diabetic Foot Unit, SOD Diabetologia-Azienda Ospedaliero Universitaria Careggi, Via delle Oblate n. 4, 50141, Florence, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Aleffi
authors.affiliation: Department of Immunohematology and Transfusion Medicine, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Mirabella
authors.affiliation: Diabetic Foot Unit, SOD Diabetologia-Azienda Ospedaliero Universitaria Careggi, Via delle Oblate n. 4, 50141, Florence, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Giannoni
authors.affiliation: Diabetic Foot Unit, SOD Diabetologia-Azienda Ospedaliero Universitaria Careggi, Via delle Oblate n. 4, 50141, Florence, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Mannucci
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D003646:Debridement / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000628:therapy*; D017719:Diabetic Foot / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D054020:Lasers, Gas / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents
keywords: CO2 laser; Foot ulcer; Randomized trial; Type 2 diabetes