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Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers

NCT01376050 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-12-11

Study results available
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Summary

The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.

Conditions

  • Venous Stasis Ulcer

Interventions

DEVICE

Erchonia ML Scanner (MLS)

Erchonia MLS comprises three 17.5 mW 635 nm 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.

DEVICE

Placebo Laser

Placebo Laser has no therapeutic output emitted.

Sponsors & Collaborators

  • Erchonia Corporation

    lead INDUSTRY

Principal Investigators

  • Jeffery Kenkel, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • France

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 NCT01376050 on ClinicalTrials.gov