CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

A Randomised, Open Label, Controlled Clinical Study to Evaluate the Efficacy and Safety of CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.

The present study is designed to assess the antimicrobial effect of a single CO2 laser beam (DEKA SmartXide2 c80-El.En, Florence Italy) in the treatment of diabetic infected foot ulcers. CO2 laser debridement will be compared with standard surgical care. The primary efficacy endpoint will be the reduction of bacterial load between pre- and immediately after debridement. Secondary endpoints will be adverse events and pain during treatment. Two bacterial sample with a flocked nylon swab will be collected before and after debridement.

Inclusion Criteria:

• Diabetes
• Infected foot ulcer (with clinical signs of infection)
• Ulcer area between 0.5 and 150 cm2
• More than 50% of ulcer area covered by fibrin and/or necrosis
• Texas score <3

Exclusion Criteria:

• Need for revascularization
• Pregnancy or lactation