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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 laser | Experimental | Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) |
|
| Traditional surgery | Active Comparator | Ulcer debridement with traditional surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 laser | Procedure | Single session of CO2 laser debridement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure. |
| Fibrin: Percent of Ulcer Area Covered by Fibrin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo Mannucci, MD | University of Florence | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | CO2 Laser | Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement |
| FG001 | Traditional Surgery | Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CO2 Laser | Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement |
| BG001 | Traditional Surgery | Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Load | Percent change in bacterial colonies from baseline. | Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded. | Posted | Median | Inter-Quartile Range | Percent change from baseline | Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure. |
|
During procedure and after 1h.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CO2 Laser | Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matteo Monami, Director Diabetic Foot Unit | AOU Careggi | 00390557946563 | matteo.monami@unifi.it |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| traditional surgery |
| Procedure |
Single session of traditional debridement |
|
Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure
| 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. | Baseline and immediately after procedure |
| Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | proportion of patients with bleeding necessitating haemostasis | during procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Diabetes duration | Mean | Standard Deviation | years |
|
| HbA1c | Mean | Standard Deviation | percentage of total hemoglobin |
|
| Duration of ulcer | Mean | Standard Deviation | months |
|
| Ulcer area | Mean | Standard Deviation | cm^2 |
|
|
|
| Secondary | 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. | ITT analysis: patients with no detectable bacterial load at baseline were included. | Posted | Median | Inter-Quartile Range | cm for a VAS scale. | During procedure. |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Percent change from baseline | Baseline and immediately after the end of procedure |
|
|
|
| Secondary | 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. | ITT analysis: patients with no detectable bacterial load at baseline were included. | Posted | Median | Inter-Quartile Range | Percent change from baseline | Baseline and immediately after procedure |
|
|
|
| Secondary | Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | proportion of patients with bleeding necessitating haemostasis | ITT analysis: patients with no detectable bacterial load at baseline were included. | Posted | Number | participants | during procedure |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Traditional Surgery | Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement | 0 | 10 | 8 | 10 |
| Pain needing anesthesia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |