CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Procedure: CO2 laser
* Procedure: traditional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 laser<br>Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) | Procedure: CO2 laser<br>* Single session of CO2 laser debridement<br>|
| Active Comparator: Traditional surgery<br>Ulcer debridement with traditional surgery | Procedure: traditional surgery<br>* Single session of traditional debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Load | Percent change in bacterial colonies from baseline. | Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Baseline and immediately after procedure | 
| Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | proportion of patients with bleeding necessitating haemostasis | during procedure |