New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Number of Participants With Trophic Ulcer Healing
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age,
- •CVI Stage 6 (S6) in compliance with СЕАР
排除标准
- •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
研究组 & 干预措施
Conventional treatment
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).
干预措施: Conventional therapy (Other)
Conventional therapy and combined LLLT
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
干预措施: LASMIK (Device)
Conventional therapy and combined LLLT
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
干预措施: Conventional therapy (Other)
结局指标
主要结局
Number of Participants With Trophic Ulcer Healing
时间窗: 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.
次要结局
未报告次要终点