LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency; Trophic Ulcers

• Registration Number: NCT03104985
• Lead Sponsor: Research Center Matrix

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-07
• Results First Submitted: 2017-04-17
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Results First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Trophic Ulcer Healing	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.

Trial Locations

Locations (1)

Tula Municipal Clinical Hospital №2; 🇷🇺 Tula, Russian Federation