CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677779
• Other study ID #: SPE 15.161
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: August 1, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Procedure:
• CO2 laser
Single session of CO2 laser debridement
• traditional surgery
Single session of traditional debridement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial load	Number of bacterial colonies in a sample collected with a swab from ulcer bed	Immediately after the end of procedure	No
Secondary	Pain: Scores of Brief Pain Inventory	Scores of Brief Pain Inventory	during procedure	No
Secondary	Fibrin: percent of ulcer area covered by fibrin	percent of ulcer area covered by fibrin	immediately after procedure	No
Secondary	Necrosis: percent of ulcer area covered by necrotic tissue	percent of ulcer area covered by necrotic tissue	immediately after procedure	No
Secondary	Granulation: proportion of patients with at least 90% of ulcer area covered by granulation tissue	proportion of patients with at least 90% of ulcer area covered by granulation tissue	immediately after procedure	No
Secondary	Bleeding: proportion of patients with bleeding necessitating haemostasis	proportion of patients with bleeding necessitating haemostasis	during procedure	No