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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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 groups in NCT02677779
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.

Jan 2016Mar 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

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.

Detailed description

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

Results posted to the registry on 6 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CO2 Laser	10	10
Traditional Surgery	10	10

Primary outcome: Bacterial Load

Time frame: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.. Median (Inter-Quartile Range). Unit: Percent change from baseline

Measure	CO2 Laser n = 8	Traditional Surgery n = 8
Value	-99.9 (-100 to -90)	-50.0 (-96.0 to 0)

Population analysed: Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During procedure and after 1h.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CO2 Laser	0 of 10 (0%)	3 of 10 (30%)	Not reported
Traditional Surgery	0 of 10 (0%)	8 of 10 (80%)	Not reported

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

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

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?

On the ClinicalTrials.gov record for NCT02677779.

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.