Trial Outcomes & Findings for CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers (NCT NCT02677779)

NCT ID: NCT02677779

Last Updated: 2016-12-06

Results Overview

Percent change in bacterial colonies from baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.
• Results posted on: 2016-12-06

Participant Flow

Participant milestones

Measure	CO2 Laser Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers

Baseline characteristics by cohort

Measure	CO2 Laser n=10 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement	Total n=20 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 11.1 • n=93 Participants	76.8 years STANDARD_DEVIATION 8.6 • n=4 Participants	71.9 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Region of Enrollment Italy	10 participants n=93 Participants	10 participants n=4 Participants	20 participants n=27 Participants
Body Mass Index	25.6 Kg/m^2 STANDARD_DEVIATION 7.0 • n=93 Participants	30.8 Kg/m^2 STANDARD_DEVIATION 8.2 • n=4 Participants	28.2 Kg/m^2 STANDARD_DEVIATION 7.5 • n=27 Participants
Diabetes duration	13.7 years STANDARD_DEVIATION 12.1 • n=93 Participants	20.3 years STANDARD_DEVIATION 10.5 • n=4 Participants	17.1 years STANDARD_DEVIATION 11.2 • n=27 Participants
HbA1c	6.6 percentage of total hemoglobin STANDARD_DEVIATION 1.0 • n=93 Participants	7.4 percentage of total hemoglobin STANDARD_DEVIATION 1.4 • n=4 Participants	7.0 percentage of total hemoglobin STANDARD_DEVIATION 1.3 • n=27 Participants
Duration of ulcer	5.6 months STANDARD_DEVIATION 5.3 • n=93 Participants	3.3 months STANDARD_DEVIATION 3.4 • n=4 Participants	4.6 months STANDARD_DEVIATION 4.3 • n=27 Participants
Ulcer area	2.0 cm^2 STANDARD_DEVIATION 1.7 • n=93 Participants	2.7 cm^2 STANDARD_DEVIATION 2.8 • n=4 Participants	2.3 cm^2 STANDARD_DEVIATION 2.2 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Percent change in bacterial colonies from baseline.

Outcome measures

Measure	CO2 Laser n=8 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=8 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Bacterial Load	-99.9 Percent change from baseline Interval -100.0 to -90.0	-50.0 Percent change from baseline Interval -96.0 to 0.0

SECONDARY outcome

Timeframe: During procedure.

Population: ITT analysis: patients with no detectable bacterial load at baseline were included.

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

Outcome measures

Measure	CO2 Laser n=10 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Pain: Scores of Brief Pain Inventory	0 cm for a VAS scale. Interval 0.0 to 1.5	1.0 cm for a VAS scale. Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	CO2 Laser n=10 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Fibrin: Percent of Ulcer Area Covered by Fibrin	-83.1 Percent change from baseline Interval -91.9 to -75.9	-42.9 Percent change from baseline Interval -61.7 to -30.3

SECONDARY outcome

Timeframe: Baseline and immediately after procedure

Population: ITT analysis: patients with no detectable bacterial load at baseline were included.

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

Outcome measures

Measure	CO2 Laser n=10 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Granulation: Percent of Ulcer Area Covered by Granulation.	307.7 Percent change from baseline Interval 164.8 to 932.8	230.4 Percent change from baseline Interval 125.4 to 855.4

SECONDARY outcome

Timeframe: during procedure

Population: ITT analysis: patients with no detectable bacterial load at baseline were included.

proportion of patients with bleeding necessitating haemostasis

Outcome measures

Measure	CO2 Laser n=10 Participants Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 Participants Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis	2 participants	8 participants

Adverse Events

CO2 Laser

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Traditional Surgery

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CO2 Laser n=10 participants at risk Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy) CO2 laser: Single session of CO2 laser debridement	Traditional Surgery n=10 participants at risk Ulcer debridement with traditional surgery traditional surgery: Single session of traditional debridement
Injury, poisoning and procedural complications Bleeding	20.0% 2/10 • Number of events 2 • During procedure and after 1h.	80.0% 8/10 • Number of events 8 • During procedure and after 1h.
Injury, poisoning and procedural complications Pain needing anesthesia	20.0% 2/10 • Number of events 2 • During procedure and after 1h.	10.0% 1/10 • Number of events 1 • During procedure and after 1h.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • During procedure and after 1h.	20.0% 2/10 • Number of events 2 • During procedure and after 1h.

Additional Information

Dr. Matteo Monami, Director Diabetic Foot Unit

AOU Careggi

Phone: 00390557946563

Email: matteo.monami@unifi.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place