Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- visual analog scale of pain
研究概览
简要总结
Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).
详细描述
Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.
The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.
Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.
Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.
Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type II diabetes mellitus
- •diabetic peripheral neuropathy
- •six months duration of symptoms,
排除标准
- •other causes of neuropathy
- •patient refusal
- •ulcers or amputations
- •peripheral vascular diseases
- •vertebral spine disease
- •connective tissue disease
- •platelet dysfunction syndrome
- •critical thrombocytopenia
- •local infection
- •coagulopathy
研究组 & 干预措施
Intervention
peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
干预措施: perineural injection of platelet-rich plasma (Other)
Intervention
peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
干预措施: medical (Drug)
Control
medical treatment only
干预措施: medical (Drug)
结局指标
主要结局
visual analog scale of pain
时间窗: 6 months
it will be measured by visual analog scale
次要结局
- Nerve conduction velocity(6 months)
