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

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CO2 laser

traditional surgery

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CO2 laser

Traditional surgery

Arm Description

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

Ulcer debridement with traditional surgery

Outcomes

Primary Outcome Measures

Bacterial Load

Percent change in bacterial colonies from baseline.

Secondary Outcome Measures

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.

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

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.

Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis

proportion of patients with bleeding necessitating haemostasis

Full Information

NCT ID

NCT02677779

First Posted

February 3, 2016

Last Updated

October 13, 2016

Sponsor

Azienda Ospedaliero-Universitaria Careggi

1. Study Identification

Unique Protocol Identification Number

NCT02677779

Brief Title

CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Acronym

DULCIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CO2 laser

Arm Type

Experimental

Arm Description

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

Arm Title

Traditional surgery

Arm Type

Active Comparator

Arm Description

Ulcer debridement with traditional surgery

Intervention Type

Procedure

Intervention Name(s)

CO2 laser

Intervention Description

Single session of CO2 laser debridement

Intervention Type

Procedure

Intervention Name(s)

traditional surgery

Intervention Description

Single session of traditional debridement

Primary Outcome Measure Information:

Title

Bacterial Load

Description

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 Outcome Measure Information:

Title

Pain: Scores of Brief Pain Inventory

Description

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.

Title

Fibrin: Percent of Ulcer Area Covered by Fibrin

Description

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

Title

Granulation: Percent of Ulcer Area Covered by Granulation.

Description

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

Time Frame

Baseline and immediately after procedure

Title

Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis

Description

proportion of patients with bleeding necessitating haemostasis

Time Frame

during procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edoardo Mannucci, MD

Organizational Affiliation

University of Florence

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

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