CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers (DULCIS)

Azienda Ospedaliero-Universitaria Careggi

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: CO2 laser; Procedure: traditional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02677779

SPE 15.161

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CO2 laser

Experimental group

Description:

Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)

Treatment:

Procedure: CO2 laser

Traditional surgery

Active Comparator group

Description:

Ulcer debridement with traditional surgery

Treatment:

Procedure: traditional surgery