Trial Outcomes & Findings for Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers (NCT NCT01376050)
NCT ID: NCT01376050
Last Updated: 2015-12-11
Results Overview
'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.
TERMINATED
NA
24 participants
Baseline and 12 Weeks
2015-12-11
Participant Flow
Participant milestones
| Measure |
Erchonia ML Scanner (MLS)
Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
|
Placebo Laser
Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers
Baseline characteristics by cohort
| Measure |
Erchonia ML Scanner (MLS)
n=13 Participants
Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
|
Placebo Laser
n=11 Participants
Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.92 years
STANDARD_DEVIATION 14.78 • n=5 Participants
|
65.80 years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
67.00 years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Ulcer Size
|
10.13 cm²
STANDARD_DEVIATION 6.23 • n=5 Participants
|
11.30 cm²
STANDARD_DEVIATION 7.55 • n=7 Participants
|
10.53 cm²
STANDARD_DEVIATION 6.64 • n=5 Participants
|
|
Visual Analog Scale (VAS) Degree of Ulcer Pain Rating
|
44.69 units on a scale
STANDARD_DEVIATION 23.93 • n=5 Participants
|
30.45 units on a scale
STANDARD_DEVIATION 20.04 • n=7 Participants
|
38.17 units on a scale
STANDARD_DEVIATION 22.93 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 Weeks'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.
Outcome measures
| Measure |
Erchonia ML Scanner (MLS)
n=13 Participants
Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
|
Placebo Laser
n=11 Participants
Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
|
|---|---|---|
|
Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksThe study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.
Outcome measures
| Measure |
Erchonia ML Scanner (MLS)
n=13 Participants
Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
|
Placebo Laser
n=11 Participants
Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
|
|---|---|---|
|
Change in Ulcer Size
|
-6.26 cm²
Standard Deviation 3.66
|
-6.72 cm²
Standard Deviation 5.06
|
Adverse Events
Erchonia ML Scanner (MLS)
Placebo Laser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place