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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02677779
Other study ID # SPE 15.161
Secondary ID
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


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
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