LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Trophic Ulcers, Chronic Venous Insufficiency

Intervention / Treatment
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* Device: LASMIK
* Other: Conventional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>Conventional treatment only. An elastic compression of lower extremities: elastic bandages or compression hosiery of class 2 Pharmacotherapy: Anavenol, Aescusan, Glyvenol; drugs of the Benzopyrone group, including Troxevasin and Venoruton. Trental, Aspirin and Ticlid (Ticlopidine). Nonsteroidal anti-inflammatory drugs (Nimesil, OKI), various ointments containing Heparin, corticosteroids, as well as nonsteroidal anti-inflammatory drugs. Antibiotic therapy. Topical treatment: in the presence of purulent discharge (phase I of the wound healing process) - bandaging with antiseptic solutions (1% Iodopiron solution, 0.1% Chlorhexidine solution) and hydrophilic ointments (Levosin, Levomecol). In phases II and III - after ulcer cleansing the preparations based on Hyaluronic acid (Curiozin). | Other: Conventional therapy<br>* An elastic compression of lower extremities, Pharmacotherapy, Topical treatment<br>|
| Experimental: Conventional therapy and combined LLLT<br>Conventional therapy and combined LLLT (LASMIK device) was performed. External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme: - 365-405nm, power 1-2mW, exposure 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min; - 365-405nm, 1-2mW, 2 min; - 520-525nm, 1-2mW, 5 min | Device: LASMIK<br>* the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).<br>Other: Conventional therapy<br>* An elastic compression of lower extremities, Pharmacotherapy, Topical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency