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Completed

NCT Number: NCT03104985

LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

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.

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Key information

Conditions

Trophic Ulcers Chronic Venous Insufficiency

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tula Municipal Clinical Hospital №2

Tula, 300002, Russia

About this study

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:

  • (n=34) Conventional treatment
  • (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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 18 years of age,
  • CVI Stage 6 (S6) in compliance with СЕАР

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 multiple organ failure (general severe illness),
  • cachexic syndrome (severe general exhaustion),
  • epileptic syndrome,
  • hysterical syndrome,
  • convulsive syndrome

Treatment and study plan

LASMIK

Device

the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).

Conventional Therapy

Other
  • An elastic compression of lower extremities,
  • Pharmacotherapy,
  • Topical treatment

Primary outcomes

  1. Number of Participants With Trophic Ulcer Healing

    Time frame: 6 months follow up

    Number of participants with ulcer epithelialization was counted in both groups. Trophic ulcer healing in 6 months occurred in larger number of participants of conventional therapy and combined LLLT group.

Sponsors and collaborators

Lead sponsor

Research Center Matrix

Other

Registry information

Official study title

New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2017
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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