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新一代糖尿病鞋在已愈糖尿病足患者中预防足溃疡复发的随机对照研究
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注册号:

Registration number:

ChiCTR1900025538 

最近更新日期:

Date of Last Refreshed on:

2019-08-31 

注册时间:

Date of Registration:

2019-08-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新一代糖尿病鞋在已愈糖尿病足患者中预防足溃疡复发的随机对照研究 

Public title:

Effects of diabetic footwear with vibration chip and merino wool on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: an open-label, randomized, controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

3D打印鞋及鞋垫在糖尿病高危足及糖尿病足的临床应用研究 

Scientific title:

Clinical efficacy evaluation of 3D-printed diabetic shoes and insoles on preventing foot ulceration in patients with high risk of diabetic foot or with a history of diabetic foot ulceration 

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:

高赟/陈大伟 

研究负责人:

冉兴无 

Applicant:

Yun Gao/Dawei Chen 

Study leader:

Xingwu Ran 

申请注册联系人电话:

Applicant telephone:

+86 18980606855/13981920696 

研究负责人电话:

Study leader's telephone:

+86 18980601305 

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:

wsgaoyun@126.com 

研究负责人电子邮件:

Study leader's E-mail:

ranxingwu@163.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:

中国四川成都市国学巷37号 

研究负责人通讯地址:

中国四川成都市国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019年审(96)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

West China Hospital of Sichuan University Biomedical Research Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-04 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

Zejin Zuo 

伦理委员会联系地址:

成都市国学巷37号 

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China  

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市国学巷37

Institution
hospital:

West China Hospital

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

四川省科技厅重点攻关项目 

Source(s) of funding:

the Tackling-key Project of Sichuan Department of Science and Technology Grant 2009sz0153 from the Science and Technology Bureau of Sichuan Province, China. 

研究疾病:

糖尿病足 

Target disease:

diabetic foot 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1. 主要目的:探讨新一代糖尿病鞋对已愈足溃疡的糖尿病患者预防溃疡复发的有效性。 2. 次要目的:评估糖尿病鞋是否能降低足病患者的足底压力;是否可改善下肢末端的血供和氧含量;评估患者舒适性和依存性;评估心血管疾病的发生率。 

Objectives of Study:

1. To explore the efficacy of diabetic footwear with vibration chip and merino wool on preventing ulcer recurrence in patients with a history of diabetic foot ulceration 2. To assess whether diabetic footwear with vibration chip and merino wool could reduce plantar pressure and increase blood supply and SaPO2 of lower extremity. 3. To assess comfort and adherence 4. To evaluate incidence of cardiovascular events 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄≥18岁 2. 明确诊断的1型或2型糖尿病 3. 糖尿病周围神经病变导致保护性感觉减退或丧失 4. 在随机入组前1年曾发生足溃疡并已治愈 

Inclusion criteria

1. aged >=18 years; 2. type 1 or type 2 diabetes mellitus; 3. decrease or loss of protective foot sensation due to/as a result of diabetic peripheral neuropathy; 4. had a healed foot ulceration in the 12 months prior to/preceding randomization. 

排除标准:

1. 跖骨关节附近及以上的双侧截趾或截肢 2. 需使用助行器械辅助行走或减轻足底压力 3. 严重下肢外周动脉疾病(ABI<0.4)或伴间隙性跛行或静息痛 4. 其它系统疾患所致骨关节疾病 5. 经治疗或校正后仍影响日常活动的视力减退或视力丧失 6. 不稳定性心脑血管疾病 7. 严重肝肾功能损害 8. 恶性肿瘤 9. 患有严重疾患预期寿命不超过2年 10. 妊娠和哺乳期妇女 11. 患有神经或精神疾病影响患者依存性 

Exclusion criteria:

1. bilateral amputation proximal to the tarsometatarsal joint; 2. the use of walking aids that offload the foot); 3. severe lower extremity artery disease(ABI<0.4,intermittent claudication or rest pain)); 4. osteoarticular diseases unrelated to T1DM or T2DM; 5. decrease or loss of vision that is difficult to treat or correct; 6. Unstable cardiovascular disease or unstable ischemic cerebrovascular disease; 7. severe renal dysfunction or severe liver dysfunction; 8. malignant tumor; 9. severe illness that would make 24-month survival unlikely (as judged by the patients physician); 10. Pregnancy or breast-feeding women; 11. Neurologic or psychiatric disease that may prevent compliance with the protocol. 

研究实施时间:

Study execute time:

From2019-09-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

160

Group:

Experimental group

Sample size:

干预措施:

新一代糖尿病鞋

干预措施代码:

Intervention:

diabetic footwear with vibration chip and merino wool

Intervention code:

组别:

对照组

样本量:

160

Group:

control group

Sample size:

干预措施:

常规护理鞋

干预措施代码:

Intervention:

routine custom-made footwear

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

溃疡复发率

指标类型:

主要指标 

Outcome:

ulcer recurrence rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

足底压力降低程度

指标类型:

主要指标 

Outcome:

in-shoe plantar pressures

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢血供改善情况

指标类型:

次要指标 

Outcome:

blood flow velocity of lower extremity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

经皮氧分压

指标类型:

次要指标 

Outcome:

transcutaneous oxygen pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管事件发生率

指标类型:

次要指标 

Outcome:

incidence of cardiovascular events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 years
最大 Max age 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):

卫生统计学专家采用SAS统计软件的 PROC PLAN过程语句,给定种子数,模拟产生320例受试者所接受处理(试验用鞋和对照用鞋)的随机序列号

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

Guanjian Liu, a professor of statistics, use SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) to generate random sequence Numbers

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

试验完成后6个月内在临床试验公共管理平台 (www.medresman.org)上公开

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

Within six months after the trial complete on ResMan (www.medresman.org)

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:

所有入组的受试者均将在病例记录表上记录所有的信息,然后通过epidata和excel表格储存电子版本的数据。每周将会有专人核对信息录入的准确性。

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

The information for all participants will be recorded in case record form (CRF) and the electronic data will be collected via epidata and excel. Every week another independent investigator will check the electronic data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-31
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