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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Procedure: CO2 laser; Procedure: traditional surgery

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Edoardo Mannucci, MD, University of Florence

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: SPE 15.161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No