CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

NCT02677779 | Completed Results

• 1 other identifier: SPE 15.161
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Bacterial Load

  Percent change in bacterial colonies from baseline.

  Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.

Secondary Outcomes (4)

• Pain: Scores of Brief Pain Inventory

  During procedure.

• Fibrin: Percent of Ulcer Area Covered by Fibrin

  Baseline and immediately after the end of procedure

• Granulation: Percent of Ulcer Area Covered by Granulation.

  Baseline and immediately after procedure

• Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis

  during procedure

Study Arms (2)

CO2 laser

EXPERIMENTAL

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

Procedure: CO2 laser

Traditional surgery

ACTIVE COMPARATOR

Ulcer debridement with traditional surgery

Procedure: traditional surgery

Interventions

CO2 laser PROCEDURE

Single session of CO2 laser debridement

CO2 laser

traditional surgery PROCEDURE

Single session of traditional debridement

Traditional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Need for revascularization
• Pregnancy or lactation

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Matteo Monami, Director Diabetic Foot Unit
• Organization: AOU Careggi

matteo.monami@unifi.it

00390557946563

Study Officials

• Edoardo Mannucci, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetology

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 9, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 6, 2016
• Results First Posted: December 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share