N/A N=20 Randomized Treatment

CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Diabetic Foot Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT02677779 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Bacterial Load — -99.9; -50.0 Percent change from baseline

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CO2 laser (Procedure); traditional surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Bacterial Load	-99.9; -50.0	—
SECONDARY Pain: Scores of Brief Pain Inventory	0; 1.0	—
SECONDARY Fibrin: Percent of Ulcer Area Covered by Fibrin	-83.1; -42.9	—
SECONDARY Granulation: Percent of Ulcer Area Covered by Granulation.	307.7; 230.4	—
SECONDARY Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis	2; 8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02677779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.