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CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

NCT ID: NCT02677779

Last Updated: 2016-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CO2 laser

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

Group Type EXPERIMENTAL

CO2 laser

Intervention Type PROCEDURE

Single session of CO2 laser debridement

Traditional surgery

Ulcer debridement with traditional surgery

Group Type ACTIVE_COMPARATOR

traditional surgery

Intervention Type PROCEDURE

Single session of traditional debridement

Interventions

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CO2 laser

Single session of CO2 laser debridement

Intervention Type PROCEDURE

traditional surgery

Single session of traditional debridement

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Mannucci

Director, Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edoardo Mannucci, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Other Identifiers

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SPE 15.161

Identifier Type: -

Identifier Source: org_study_id