CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: traditional surgery; Procedure: CO2 laser

• Registration Number: NCT02677779
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-08-19
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Results First Posted: 2016-12-06
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional surgery	traditional surgery	Ulcer debridement with traditional surgery
CO2 laser	CO2 laser	Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)

Primary Outcome Measures

Name	Time	Method
Bacterial Load	Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.	Percent change in bacterial colonies from baseline.

Secondary Outcome Measures

Name	Time	Method
Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis	during procedure	proportion of patients with bleeding necessitating haemostasis
Fibrin: Percent of Ulcer Area Covered by Fibrin	Baseline and immediately after the end of procedure	Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure
Pain: Scores of Brief Pain Inventory	During procedure.	Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.
Granulation: Percent of Ulcer Area Covered by Granulation.	Baseline and immediately after procedure	Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.