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Laser Therapy for Diabetic Peripheral Neuropathic Pain

NCT02328911 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-28

No results posted yet for this study

Summary

The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The hypothesis is that laser therapy will produce significant improvement on measures of self-reported pain among adults with diabetes.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Laser treatment

Laser energy will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits therapeutic dual-wavelength infrared laser energy as well as red visible light.

DEVICE

Sham treatment

A sham treatment will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits only red visible light.

Sponsors & Collaborators

  • LiteCure LLC

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • John E. Lewis, Ph.D. · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

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 NCT02328911 on ClinicalTrials.gov