LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Last updated: February 22, 2018
Sponsor: Research Center Matrix
Overall Status: Completed

Phase

N/A

Condition

Deep Vein Thrombosis

Vascular Diseases

Ulcers

Treatment

N/A

Clinical Study ID

NCT03104985
LLLT-trophic-ulcers-Tula
  • Ages 18-85
  • All Genders

Study Summary

The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device.

The results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • over 18 years of age,

  • CVI Stage 6 (S6) in compliance with СЕАР

Exclusion

Exclusion Criteria:

  • hemorrhagic syndrome,

  • neoplastic syndrome,

  • hyperthermic syndrome (fever, patient body temperature over 38°C),

  • syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multipleorgan failure (general severe illness),

  • cachexic syndrome (severe general exhaustion),

  • epileptic syndrome,

  • hysterical syndrome,

  • convulsive syndrome

Study Design

Total Participants: 68
Study Start date:
May 01, 2013
Estimated Completion Date:
December 31, 2015

Study Description

During a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. International classification of lower extremity chronic venous disorders СЕАР was used as a clinical classification of chronic venous insufficiency (CVI).

Depending on the applied treatment method, patients were divided into 2 groups:

  1. (n=34) Conventional treatment

  2. (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

Connect with a study center

  • Tula Municipal Clinical Hospital №2

    Tula, 300002
    Russian Federation

    Site Not Available

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