Diabetic Foot UlcerDULCISNCT02677779
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
A study testing CO2 laser and traditional surgery in people with Diabetic Foot Ulcer, run by Azienda Ospedaliero-Universitaria Careggi.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- CO2 laser and traditional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Need for revascularization
- Pregnancy or lactation
About this study
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
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.
Read the detailed 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- CO2 laser, traditional surgery
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laserProcedure or surgery
Single session of CO2 laser debridement
traditional surgeryProcedure or surgery
Single session of traditional debridement
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser | Experimental | Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) Receives: Procedure: CO2 laser |
| Traditional surgery | Active comparator | Ulcer debridement with traditional surgery Receives: Procedure: traditional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Load
Percent change in bacterial colonies from baseline.
Measured: 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
Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.
Measured: During procedure.
Fibrin: Percent of Ulcer Area Covered by Fibrin
Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure
Measured: Baseline and immediately after the end of procedure
Granulation: Percent of Ulcer Area Covered by Granulation.
Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.
Measured: Baseline and immediately after procedure
Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis
proportion of patients with bleeding necessitating haemostasis
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Edoardo Mannucci, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677779
- Sponsor's protocol ID
- SPE 15.161
- Acronym
- DULCIS
- Status last verified
- Oct 2016
- First submitted
- 3 Feb 2016
- Last updated
- 6 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677779
- Acronym / sponsor ID
- DULCIS / SPE 15.161
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser | Experimental | Procedure: CO2 laserUlcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) |
| Traditional surgery | Active comparator | Procedure: traditional surgeryUlcer debridement with traditional surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Need for revascularization
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laserSingle session of CO2 laser debridement | Procedure or surgery | CO2 laser |
| traditional surgerySingle session of traditional debridement | Procedure or surgery | Traditional surgery |
Primary outcome
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.
4 secondary outcomes
Pain: Scores of Brief Pain Inventory
Time frame: During procedure.
Fibrin: Percent of Ulcer Area Covered by Fibrin
Time frame: Baseline and immediately after the end of procedure
Granulation: Percent of Ulcer Area Covered by Granulation.
Time frame: Baseline and immediately after procedure
Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis
Time frame: during procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo Mannucci, MD principal investigator
University of Florence
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser and traditional surgery in people with Diabetic Foot Ulcer, run by Azienda Ospedaliero-Universitaria Careggi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Load (time frame: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.