Diabetic Foot Ulcer
Conditions
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.
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.
Interventions
PROCEDURECO2 laser
Single session of CO2 laser debridement
PROCEDUREtraditional surgery
Single session of traditional debridement
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Load | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain: Scores of Brief Pain Inventory | During procedure. | Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine. |
| Fibrin: Percent of Ulcer Area Covered by Fibrin | 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 |
| Granulation: Percent of Ulcer Area Covered by Granulation. | Baseline and immediately after procedure | Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure. |
| Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | during procedure | proportion of patients with bleeding necessitating haemostasis |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CO2 Laser Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
CO2 laser: Single session of CO2 laser debridement | 10 |
| Traditional Surgery Ulcer debridement with traditional surgery
traditional surgery: Single session of traditional debridement | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | CO2 Laser | Traditional Surgery | Total |
|---|---|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 11.1 | 76.8 years STANDARD_DEVIATION 8.6 | 71.9 years STANDARD_DEVIATION 9.9 |
| Body Mass Index | 25.6 Kg/m^2 STANDARD_DEVIATION 7 | 30.8 Kg/m^2 STANDARD_DEVIATION 8.2 | 28.2 Kg/m^2 STANDARD_DEVIATION 7.5 |
| Diabetes duration | 13.7 years STANDARD_DEVIATION 12.1 | 20.3 years STANDARD_DEVIATION 10.5 | 17.1 years STANDARD_DEVIATION 11.2 |
| Duration of ulcer | 5.6 months STANDARD_DEVIATION 5.3 | 3.3 months STANDARD_DEVIATION 3.4 | 4.6 months STANDARD_DEVIATION 4.3 |
| HbA1c | 6.6 percentage of total hemoglobin STANDARD_DEVIATION 1 | 7.4 percentage of total hemoglobin STANDARD_DEVIATION 1.4 | 7.0 percentage of total hemoglobin STANDARD_DEVIATION 1.3 |
| Region of Enrollment Italy | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
| Ulcer area | 2.0 cm^2 STANDARD_DEVIATION 1.7 | 2.7 cm^2 STANDARD_DEVIATION 2.8 | 2.3 cm^2 STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Bacterial Load
Percent change in bacterial colonies from baseline.
Time frame: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.
Population: Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CO2 Laser | Bacterial Load | -99.9 Percent change from baseline |
| Traditional Surgery | Bacterial Load | -50.0 Percent change from baseline |
Secondary
Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis
proportion of patients with bleeding necessitating haemostasis
Time frame: during procedure
Population: ITT analysis: patients with no detectable bacterial load at baseline were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2 Laser | Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | 2 participants |
| Traditional Surgery | Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis | 8 participants |
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
Time frame: Baseline and immediately after the end of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CO2 Laser | Fibrin: Percent of Ulcer Area Covered by Fibrin | -83.1 Percent change from baseline |
| Traditional Surgery | Fibrin: Percent of Ulcer Area Covered by Fibrin | -42.9 Percent change from baseline |
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.
Time frame: Baseline and immediately after procedure
Population: ITT analysis: patients with no detectable bacterial load at baseline were included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CO2 Laser | Granulation: Percent of Ulcer Area Covered by Granulation. | 307.7 Percent change from baseline |
| Traditional Surgery | Granulation: Percent of Ulcer Area Covered by Granulation. | 230.4 Percent change from baseline |
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.
Time frame: During procedure.
Population: ITT analysis: patients with no detectable bacterial load at baseline were included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CO2 Laser | Pain: Scores of Brief Pain Inventory | 0 cm for a VAS scale. |
| Traditional Surgery | Pain: Scores of Brief Pain Inventory | 1.0 cm for a VAS scale. |