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临床试验/NCT03250403
NCT03250403已完成不适用

Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy: Double Blinded Randomized Controlled Trial

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4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
Numbness

研究概览

简要总结

To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

详细描述

Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide clinical spectrum that encompasses generalized to focal and multifocal forms not only leads to an impaired quality of life, but also to an increased morbidity and mortality . Till now there is no available effective therapy for the treatment of diabetic peripheral neuropathy (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides necessary growth factors that promote wound healing/growth, angiogenesis, and axon regeneration .

Objective

To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Method : Prospective double blinded randomized controlled trial was conducted . All included patients had type 2 DM selected from Endocrinology unit Department of Internal medicine, Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were double blindly divided into two groups, Group I underwent PRP preineural injection under ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control group) . Blood glucose was strictly controlled in both groups . Patients were followed every month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means ± standard deviation or frequencies. Independent Student's t test was done for comparison between groups

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic peripheral neuropathy of at least 5 years duration of symptoms

排除标准

  • hereditary neuropathies , entrapment neuropathies , connective tissue diseases , vertebral diseases , thyroid disorders and end organ failure

研究组 & 干预措施

PRP injection

Experimental

干预措施: PRP injection (Drug)

PRP injection

Experimental

干预措施: traditional medical treatment (Other)

medical treatment

Active Comparator

干预措施: traditional medical treatment (Other)

结局指标

主要结局

Numbness

时间窗: 6 months

modified Toronto Clinical Neuropathy Score

pain

时间窗: 6 months

VAS 0-10 scale

次要结局

  • Conduction velocity(6 months)

研究者

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

Manal Hassanien

Prenciple investigator

Assiut University

研究点 (1)

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