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

NCT02461225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-15

Study results available
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Summary

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.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Erchonia® FX-635™

The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.

DEVICE

Placebo Laser

The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.

Sponsors & Collaborators

  • Erchonia Corporation

    lead INDUSTRY

Principal Investigators

  • Kerry Zang, DPN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-07-01
Completion
2017-09-30
FDA Device
Yes

Countries

  • United States
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461225 on ClinicalTrials.gov