CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Azienda Ospedaliero-Universitaria Careggi20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

CO2 laserPROCEDURE

Single session of CO2 laser debridement

traditional surgeryPROCEDURE

Single session of traditional debridement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bacterial Load

Percent change in bacterial colonies from baseline.

Time frame: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.

Secondary Outcomes

Pain: Scores of Brief Pain Inventory

Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.

Time frame: During procedure.

Fibrin: Percent of Ulcer Area Covered by Fibrin

Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure

Time frame: Baseline and immediately after the end of procedure

Granulation: Percent of Ulcer Area Covered by Granulation.

Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.

Time frame: Baseline and immediately after procedure

Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis

proportion of patients with bleeding necessitating haemostasis

Time frame: during procedure

Data from ClinicalTrials.gov

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