NCT02461225

Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain

Completed NA Results posted Last updated 15 March 2022

What this trial tests

NA trial testing Erchonia® FX-635™ in Diabetic Peripheral Neuropathy in 30 participants. Completed in 30 September 2017.

Timeline

1 March 2016

Primary endpoint
1 July 2017

30 September 2017

Quick facts

Lead sponsor	Erchonia Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 March 2016
Primary completion	1 July 2017
Estimated completion	30 September 2017
Sites	2 locations across Ireland, United States

Drugs / interventions tested

• Erchonia® FX-635™
• Placebo Laser

Conditions studied

• Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →

Sponsor

Erchonia Corporation — full company profile →

Who can join

18 and older, any sex, with Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) Primary · Baseline and 6 weeks

The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or

Group	Value	95% CI
Erchonia® FX-635™	18
Placebo Laser	4

Change in Pain Rating on the Visual Analog Scale (VAS) Secondary · 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. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.

Group	Value	95% CI
Erchonia® FX-635™	-60.97	± 23.28
Placebo Laser	-9.09	± 34.06

Sponsor's own description

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.