LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
Trophic Ulcers, Chronic Venous Insufficiency
About this trial
This is an interventional treatment trial for Trophic Ulcers focused on measuring Trophic ulcer; low level laser therapy; Chronic Venous Insufficiency
Eligibility Criteria
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
Sites / Locations
- Tula Municipal Clinical Hospital №2
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional treatment
Conventional therapy and combined LLLT
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).
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