Effect of Transcutaneous Electrical Nerve Stimulation on Proinflammatory Cytokines, Angiogenic and Growth Factors in Subjects with Venous Ulcers of the Lower Extremities: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities
研究概览
简要总结
Abstract Evaluate the effect of transcutaneous electrical nerve stimulation on proinflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities.
Material and Methods A randomized, double-blind, placebo-controlled, parallel-groups clinical trial was carried out in 32 adults (18-75 years of age) with venous ulcers of the lower extremities according to CEAP classification with duple Doppler ultrasound. After random allocation of intervention 16 patients received continuous and intermittent transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. Proinflammatory cytokines, angiogenic and growth factors were measured before and after intervention. Mann-Whitney U test and Wilcoxon's rank-sum test were performed to statistical analyses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Venous ulcers C6,Es, As/Ap,Pr according to CEAP classification by Spanish Society of Angiology and Vascular Surgery or demonstrated with duplex Doppler ultrasound
- •Who did not respond to conventional treatment.
- •Evolution of no less than 12 weeks
- •Ulcers with a size > 2 and < 12 cm in any of its dimensions did not affect the dermis and epidermis, but should not spread to the tendon or bone, without formation of ischemia and infection.
排除标准
- •Patients with active superficial or deep thrombus phlebitis, chronic arterial insufficiency (figures less than 0.8 in IPTB), neoplasms.
- •Treated with chemotherapy or radiation therapy
- •Clinically infected ulcers at the time of study evaluation, signs of cellulitis.
- •Osteomyelitis or ulcer with a necrotic background Individuals with a surgical history of venous insufficiency at least 12 months prior to undergoing the protocol.
- •Participants with diseases such as rheumatoid arthritis, lupus erythematosus, or disseminated, mental diseases, electrical implants (bypass), pregnancy and breastfeeding, diabetes mellitus, lung cancer, a history of stroke, or undergoing anticoagulant treatment.
- •Patients receiving corticosteroids or some other immunosuppressive, non-steroidal anti-inflammatory, histamine antagonists, or antibiotics on a regular basis within 4 weeks prior to the study.
研究组 & 干预措施
Group A Electrostimulation
Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days.
干预措施: Transcutaneous electrical neurostimulation (Device)
Group B Placebo
Transcutaneous electrical nerve stimulation without stimulation during 30 minutes three times per week for 60 days.
干预措施: Transcutaneous electrical neurostimulation (Device)
结局指标
主要结局
Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities
时间窗: From the beginning of treatment at 60 days
Changed in plasma concentration from baseline of EGF, VEGF, PDGF-BB, TNF-, IL-1, IL-6, TSP-1 and TIMP-1 and 2 from basa to 60 days
次要结局
未报告次要终点
研究者
Arieh Roldán Mercado Sesma
Associate B professor
Centro Universitario de Tonalá