Trial Outcomes & Findings for An Evaluation of the Effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy Pain (NCT NCT04006392)

Results Overview

The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2023-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia FX-635 The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. Erchonia FX-635: The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.	Placebo Laser Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. Placebo Laser: Non-therapeutic output.
Overall Study STARTED	11	7
Overall Study COMPLETED	11	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Erchonia FX-635 The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. Erchonia FX-635: The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.	Placebo Laser Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. Placebo Laser: Non-therapeutic output.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia FX-635 n=11 Participants The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. Erchonia FX-635: The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.	Placebo Laser n=7 Participants Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. Placebo Laser: Non-therapeutic output.	Total n=18 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 3 • n=11 Participants	67.3 years STANDARD_DEVIATION 8.80 • n=7 Participants	65.6 years STANDARD_DEVIATION 7.39 • n=18 Participants
Sex: Female, Male Female	7 Participants n=11 Participants	5 Participants n=7 Participants	12 Participants n=18 Participants
Sex: Female, Male Male	4 Participants n=11 Participants	2 Participants n=7 Participants	6 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline and 6 weeks

The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.

Outcome measures

Outcome measures
Measure	Erchonia FX-635 n=11 Participants The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. Erchonia FX-635: The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.	Placebo Laser n=6 Participants Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. Placebo Laser: Non-therapeutic output.
Participants With a 30% or Greater Change in Visual Analog Scale (VAS) Pain Scores	4 participants	1 participants

Adverse Events

Erchonia FX-635

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Affiairs

Erchonia Corporation

Phone: 888.242.0571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place