LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Research Center Matrix

Status: Completed

Conditions: Trophic Ulcers; Chronic Venous Insufficiency

Treatments: Other: Conventional therapy; Device: LASMIK

Study type: Interventional

Funder types: Other

Identifiers

NCT03104985

LLLT-trophic-ulcers-Tula

Details and patient eligibility

About

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.

Full 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

Enrollment: 68 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Conventional treatment

Active Comparator group

Description:

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).

Treatment:

Other: Conventional therapy

Conventional therapy and combined LLLT

Experimental group

Description:

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: 1. - 365-405nm, power 1-2mW, exposure 2 min; 2. - 520-525nm, 1-2mW, 5 min; 3. - 365-405nm, 1-2mW, 2 min; 4. - 520-525nm, 1-2mW, 5 min; 5. - 365-405nm, 1-2mW, 2 min; 6. - 520-525nm, 1-2mW, 5 min; 7. - 365-405nm, 1-2mW, 2 min; 8. - 520-525nm, 1-2mW, 5 min; 9. - 365-405nm, 1-2mW, 2 min; 10. - 520-525nm, 1-2mW, 5 min; 11. - 365-405nm, 1-2mW, 2 min; 12. - 520-525nm, 1-2mW, 5 min

Treatment:

Other: Conventional therapy

Device: LASMIK