ChiCTR2100051161 版本V1.1 版本创建时间2022/04/11 18:42:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100051161 

最近更新日期：

Date of Last Refreshed on：

2021-09-15 11:45:10 

注册时间：

Date of Registration：

2021-09-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

磁共振周围神经成像检查在糖尿病周围神经病变中的应用

Public title：

Application of Magnetic Resonance Peripheral Neurography in Diabetic Peripheral Neuropathy

注册题目简写：

磁共振周围神经成像检查在糖尿病周围神经病变中的应用

English Acronym：

Application of Magnetic Resonance Peripheral Neurography in Diabetic Peripheral Neuropathy

研究课题的正式科学名称：

磁共振周围神经成像检查在糖尿病周围神经病变中的应用

Scientific title：

Application of Magnetic Resonance Peripheral Neurography in Diabetic Peripheral Neuropathy

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张演基 

研究负责人：

王达利 

Applicant：

Zhang Yanji 

Study leader：

Wang Dali 

申请注册联系人电话：

Applicant telephone：

18524507852

研究负责人电话：

Study leader's telephone：

18089643777

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

754290854@qq.com

研究负责人电子邮件：

Study leader's E-mail：

daliwangzy@sina.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

贵州省遵义市遵义医科大学附属医院

研究负责人通讯地址：

贵州省遵义市遵义医科大学附属医院

Applicant address：

Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou Province, China

Study leader's address：

Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou Province, China

申请注册联系人邮政编码：

Applicant postcode：

563003

研究负责人邮政编码：

Study leader's postcode：

563003

申请人所在单位：

遵义医科大学附属医院

Applicant's institution：

Department of Burn plastic surgery, affiliated Hospital of Zunyi Medical University

研究负责人所在单位：

遵义医科大学附属医院烧伤整形外科

Affiliation of the Leader：

Department of Burn plastic surgery, affiliated Hospital of Zunyi Medical University

是否获伦理委员会批准：

否/No

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

遵义医科大学附属医院

Primary sponsor：

Affiliated Hospital of Zunyi Medical University

研究实施负责（组长）单位地址：

贵州省遵义市汇川区大连路149号

Primary sponsor's address：

No. 149 Dalian road, Huichuan district, Zunyi, Guizhou province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州

市(区县)：

遵义

Country：

China

Province：

Guizhou

City：

Zunyi

单位(医院)：

遵义医科大学附属医院

具体地址：

汇川区大连路149号

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Address：

149 Dalian Road, Huichuan District

经费或物资来源：

基金项目：贵州省科技计划项目，合同编号：黔科合平台人才[2020]5012

Source(s) of funding：

Fund project: Guizhou Science and Technology Plan Project, contract number: Guizhou Science and Technology Cooperation platform talents [2020] 5012

Target disease：

Diabetic peripheral neuropathy

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

糖尿病周围神经病变可引起严重的神经性疼痛或足部溃疡，导致肢体功能障碍，如不加以治疗干预进展为严重DPN和足部溃疡，5年内死亡率极高。 因此早期诊断和治疗尤为重要。NET中神经传导速度( nerve conduction velocity, NCV)测定具有高敏感性、客观可靠等优点被作为“金标准”在临床应用广泛应用。然而，NCV却不能直观显示周围神经形态变化和病变空间信息，揭示DPN病理机制潜力有限，其次NCV不具有早期诊断能力。随着功能磁共振技术的快速发展，磁共振周围神经成像（Magnetic resonance nerve, MRN)可直观显示病变神经结构，能定量评估病变范围、严重程度，尤其是扩散张量成像(diffusion tensor imaging, DTI)在检测和监测DPN的神经病变过程具有优势，甚至在DPN症状出现前发现神经纤维异常，成为DPN可靠的定量评估方法。本研究的目的在于分析糖尿病周围神经病变的磁共振特点，以及磁共振结果与临床参数对比分析两者的相关性。探讨磁共振在糖尿病周围神经病变中的应用价值  

Objectives of Study：

Diabetic peripheral neuropathy can cause severe neuropathic pain or foot ulcers, leading to limb dysfunction. If left untreated, it progresses to severe DPN and foot ulcers, and the mortality rate is extremely high within 5 years. Therefore, early diagnosis and treatment are particularly important. The measurement of nerve conduction velocity (nerveconductionvelocity,NCV) in NET has the advantages of high sensitivity, objective reliability and so on. It is widely used as the "gold standard" in clinical application. However, NCV can not directly display the morphological changes of peripheral nerves and the spatial information of lesions, and the potential of pathological mechanism of DPN is limited. Secondly, NCV does not have the ability of early diagnosis. With the rapid development of functional magnetic resonance imaging (Magneticresonancenerve,MRN), magnetic resonance peripheral neurography (Magneticresonancenerve,MRN) can directly display the neurological structure of the lesions and quantitatively evaluate the extent and severity of the lesions, especially diffusion tensor imaging (diffusiontensorimaging,DTI) has advantages in detecting and monitoring the neuropathy process of DPN, and even find nerve fiber abnormalities before the appearance of DPN symptoms, which has become a reliable quantitative evaluation method of DPN.The purpose of this study was to analyze the MRI features of diabetic peripheral neuropathy and the correlation between MRI results and clinical parameters. To explore the application value of magnetic resonance imaging in diabetic peripheral neuropathy.

药物成份或治疗方案详述：

所有患者均择期行周围神经松解术治疗，手术采用腰丛及坐骨神经阻滞麻醉，患者取仰卧位，于腓骨小头下2 cm处做一长度约为3 cm的斜切口。依次切开皮肤，分离腓总神经，于神经嵌压处切断部分肌腱，松解腓总神经，然后沿腓总神经表面向远端和近端松解神经束膜。 

Description for medicine or protocol of treatment in detail：

All patients were selectively treated with peripheral neurolysis. Lumbar plexus and sciatic nerve block anesthesia was used. Patients were taken supine position and made an oblique incision of about 3cm length at 2cm under fibula head. Cut the skin in turn, separate the common peroneal nerve, cut off part of the tendon at the nerve entrapment, release the common peroneal nerve, and then release the perineurium along the surface of the common peroneal nerve to the distal and proximal end. 

纳入标准：

（１）健康志愿者纳入标准：健康志愿者的主要纳入标准为：①年龄>18岁，②配合磁共振检查。
（2）糖尿病诊断主要根据１９９９年ＷＨＯ糖尿病诊断标准，即满足以下３条之一再加上糖尿病症状（如典型“三多一少”症状）：①随机血糖＞ｌｌ．ｌｍｍｏｌ／Ｌ；②空腹血糖＞７．０ｍｍｏｌ／Ｌ；③ＯＧＴＴ２小时血糖（糖耐量试验大于１１．ｌｍｍｏｌ／Ｌ。如被检测者无明显糖尿病症状，则需另一天复查核实而明确诊断
（3）糖尿病周围神经病变患者纳入标准：DPN患者根据NCS阳性结果和神经病变的阳性症状或体征进行诊断。NCS结果阴性、症状和体征阴性的患者被认为是无DPN。 DPN的临床标准要求存在一种以上症状(麻木、刺痛、虚弱、足痛和共济失调)或符合远端对称神经病变模式的体征(膝关节或踝关节反射异常和温度、光接触、单丝或振动感)。 NCS为阳性同时临床症状或体征为阳性纳入DPN组，否则诊断为可能DPN，予以排除。 NCS为阴性同时临床症状或体征为阴性纳入非DPN组

Inclusion criteria

(1) inclusion criteria of healthy volunteers: the main inclusion criteria of healthy volunteers are: ① age ＞ 18 years old, ② with magnetic resonance examination. (2) the diagnosis of diabetes is mainly based on the WHO diagnostic criteria of diabetes in 1999, that is, one of the following three items plus diabetic symptoms (such as typical "three more and one less" symptoms): ①Random blood glucose ＞ ll.lmmol/L;② fasting blood glucose ＞ 7.0mmol ll.lmmol/L ③ glucose (glucose tolerance test ＞ 11.lmmol/L). If the subjects have no obvious symptoms of diabetes, they need another day to check and confirm the diagnosis. (3) inclusion criteria for patients with diabetic peripheral neuropathy: DPN patients are diagnosed according to the positive results of NCS and the positive symptoms or signs of neuropathy. Patients with negative NCS results and negative symptoms and signs are considered to have no DPN. DPN clinical standards require the presence of more than one symptom (numbness, tingling, weakness, foot pain and ataxia) or signs consistent with the pattern of distal symmetrical neuropathy (abnormal knee or ankle reflex and temperature, light contact, monofilament or vibration sensation). The patients with positive NCS and positive clinical symptoms or signs were included in the DPN group, otherwise they were diagnosed as possible DPN and excluded. Negative NCS and negative clinical symptoms or signs were included in the non-DPN group.

排除标准：

（１）健康志愿者排除标准①妊娠②患有全身性神经系统疾病、创伤后改变、神经卡压综合征、肌肉骨骼疾病或可能导致周围神经异常的全身性代谢性疾病③对比区局部炎症、创伤、瘢痕、肿瘤或手术史。④任何腰椎手术或椎间盘突出史、任何 MR 成像禁忌症
（2）普通糖尿病患者的排除标准：Ｔ１ＤＭ；己知的有其他原因引起的多发性神经病变病史，如遗传；酒精、代谢除、炎症断、颈腰椎病变知、脱髓鞘病变或中毒因素发；会干扰神经传导的皮肤病变或肿胀；脑梗死及其他中枢神经系统病史；以及已知的腿部或脚踝骨折或手术史，任何腰椎手术或椎间盘突出史、任何 MR 成像禁忌症
（3）已知的由其他原因(如遗传、酒精、代谢、炎症或中毒因素)引起的多发性神经病变病史；任何腰椎手术或椎间盘突出史、任何 MR 成像禁忌症已知的腿部或脚踝骨折或手术史。患有2型糖尿病的对照组参与者也被排除在外。

Exclusion criteria：

(1) the healthy volunteers excluded standard 1 pregnancy 2 suffering from systemic neurological diseases, post-traumatic changes, nerve entrapment syndrome, musculoskeletal diseases or systemic metabolic diseases that may lead to peripheral nerve abnormalities. 3 Local inflammation, trauma, scar, tumor or surgical history in the control area. 4 any history of lumbar surgery or disc herniation, any contraindications for MR imaging (2) exclusion criteria for patients with general diabetes: T1DM; known history of polyneuropathy caused by other causes, such as heredity; alcohol, metabolic abatement, inflammatory disruption, cervicolumbar disease, demyelination or toxic factors; dermatopathy or swelling that interferes with nerve conduction; cerebral infarction and other central nervous system disease history. And any known history of leg or ankle fracture or surgery, any history of lumbar surgery or disc herniation, any MR imaging contraindications (3) any known history of polyneuropathy caused by other causes (such as genetic, alcohol, metabolic, inflammatory or toxic factors); any history of lumbar surgery or disc herniation, any known leg or ankle fracture or surgery contraindications for MR imaging. Participants in the control group with type 2 diabetes were also excluded.

研究实施时间：

Study execute time：

从 From 2021-10-01 00:00:00至 To 2023-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-10-01 00:00:00 至 To 2023-10-01 00:00:00  

干预措施：

Interventions：

组别：

DPN腓总神经卡压的患者组

样本量：

30

Group：

Group of patients with DPN common peroneal nerve entrapment

Sample size：

干预措施：

无

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

无DPN的糖尿病患者组

样本量：

30

Group：

Group of diabetic patients without DPN

Sample size：

干预措施：

无

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

健康对照组

样本量：

30

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 遵义 

Country：

China 

Province：

Guizhou 

City：

Zunyi 

单位(医院)：

遵义医科大学附属医院 

单位级别：

三级甲等 

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

磁共振扩散张量成像检查FA值

指标类型：

主要指标

Outcome：

FA value detected by magnetic resonance diffusion tensor imaging

Type：

Primary indicator

测量时间点：

腓总神经松解术术前及术后

测量方法：

磁共振扩散张量成像检查

Measure time point of outcome：

Before and after common peroneal nerve lysis

Measure method：

Magnetic resonance diffusion tensor imaging

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

用于血液检查观测患者血脂，糖化血红蛋白等常规指标

Fate of sample：

Destruction after use  

Note：

Used for blood examination to observe patients' blood lipids, glycosylated hemoglobin and other routine indexes

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

受试者不是按组招募和检查的，而是按照随机顺序进行的。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The subjects were not recruited and examined by group, but in a random order.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Do not share

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

患者基本信息，以往手术史，伴随诊断，多伦多临床系统评分（痛觉，轻触觉，温度觉，位置觉，震动觉），血脂，糖化血红蛋白，磁共振扩散张量成像FA值

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Basic patient information, previous surgical history, concomitant diagnosis, Toronto clinical system score (pain, light touch, temperature, position, vibration), blood lipids, glycosylated hemoglobin, magnetic resonance diffusion tensor imaging FA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2021-09-15 11:45:06