LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Research Center Matrix68 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trophic Ulcers Chronic Venous Insufficiency

Interventions

LASMIKDEVICE

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

Conventional therapyOTHER

* An elastic compression of lower extremities, * Pharmacotherapy, * Topical treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Tula Municipal Clinical Hospital №2

Tula, Russia

Outcomes

Primary Outcomes

Number of Participants With Trophic Ulcer Healing

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.

Time frame: 6 months follow up

Data from ClinicalTrials.gov

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