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临床试验/NCT03601494
NCT03601494已完成不适用

Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.

干预措施: medical (Drug)

Control

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Zarief , MD

Dr

Assiut University

研究点 (1)

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