Comparative study of Endovenous Laser Ablation (EVLA) and 4-Layer Bandage (4-LB) with Leech Therapy (Jalaukavacharana) and without Leech Therapy (Jalaukavacharana) in the management of Venous Ulcer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment will be done on the basis of prepared proforma and improvement in signs and symptoms of Chronic Venous Diseases
研究概览
简要总结
Venous ulceration is the most sever form of Chronic Venous Disease (CVD) results in a lot of pain and suffering to the patient. Studies on venous ulcers have shown that chronic inflammation is the main cause. The pathophysiology behind the inflammation on microcirculation level is secondary to persistent elevation of ambulatory venous pressure. Endovenous Laser ablation (EVLA) is a less invasive alternative to vein stripping. Short and mid-term studies of EVLA, regardless of wavelength used, seem remarkably consistent, typically reporting ablation of refluxing saphenous veins in 90% or more of cases. Four-layer bandaging is a high compression bandaging system that incorporates elastic layers to achieve a sustained level of compression over time.
Venous ulcers shows similarity with kaphaja vrana as described in Ayurvedic texts. Acharya Sushruta described Kaphaja Vrana symptoms as those characterised by constant and severe itching and thick margins; their surface is covered with rigid, membranous covering of veins and ligament outs tissue; they have a rigid base, anaemic look and are associated with mild pain; they have a whitish, cold and slimy discharge and give rise to a feeling of heaviness. Acharya Sushruta described Jalaouka Avacharana under Rakta-visravana in the context of Shashti Upakrama for management of Vrana. It is seen that leech application corrects venous hypertension, reduces vascular congestion due to presence of carboxypeptidase A inhibitors, histamine-like substances and acetylcholine in its saliva.
In present study total 40 patients of venous ulcers would be registered and would be enrolled after thorough interrogation, examination, laboratory investigations & Venous Duplex Study. They would be divided in two groups:
Group A: 20 patients would be treated with EVLA followed by weekly application and changing of Four layer bandage
Group B: 20 patients would be treated with EVLA followed by weekly changing of 4 layer bandage and weekly application of Leech Therapy.
Venous Duplex Ultrasonography would be done before and after the completion of treatment schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Any patient irrespective of sex or religion falling between 18-60 years of age 2) known case of venous ulcers irrespective of duration.
排除标准
- •Ulcers other than venous ulcers 2) Malignancy 3) Those allergic to local anaesthetics 4) Those having hyper-coagulable states 5) Lymphedema 6) Non-ambulatory patient 7) Those having Peripheral Arterial Insufficiency 8) Poor general health 9) Pregnant patients 10) Recent or active Thromboembolism 11) Those having Diabetes Mellitus 12) Those having Immunocompromised states 13) Those who are HIV, HBsAg and Anti-HCV Positive.
结局指标
主要结局
Assessment will be done on the basis of prepared proforma and improvement in signs and symptoms of Chronic Venous Diseases
时间窗: Duration: 3 months ; Follow-up would be done every 15 days (Total 6 follow ups would be done)
次要结局
- Improvement in criteria as per Venous Clinical Severity Score (VCSS) and Aberdeen Venous Vein Questionnaire (AVVQ)(Duration: 3 months; Follow-up would be done every 15 days (Total 6 follow ups would be done))