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Completed

NCT Number: NCT02677779

CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 laser

Procedure

Single session of CO2 laser debridement

Traditional Surgery

Procedure

Single session of traditional debridement

Primary outcomes

  1. Bacterial Load

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

    Percent change in bacterial colonies from baseline.

Secondary outcomes

  1. Pain: Scores of Brief Pain Inventory

    Time frame: During procedure.

    Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.

  2. Fibrin: Percent of Ulcer Area Covered by Fibrin

    Time frame: Baseline and immediately after the end of procedure

    Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure

  3. Granulation: Percent of Ulcer Area Covered by Granulation.

    Time frame: Baseline and immediately after procedure

    Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.

  4. Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis

    Time frame: during procedure

    proportion of patients with bleeding necessitating haemostasis

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study 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

Acronym: DULCIS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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