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脱细胞异体真皮基质复合自体皮片移植修复糖尿病足溃疡的多中心随机对照临床试验
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注册号:

Registration number:

ChiCTR1900026711 

最近更新日期:

Date of Last Refreshed on:

2019-10-19 

注册时间:

Date of Registration:

2019-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脱细胞异体真皮基质复合自体皮片移植修复糖尿病足溃疡的多中心随机对照临床试验 

Public title:

Multicentre randomized controlled clinical trial of acellular allogeneic dermal matrix combined with autologous skin graft for the repair of diabetic foot ulcers 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脱细胞异体真皮基质复合自体皮片移植修复糖尿病足溃疡的多中心随机对照临床试验 

Scientific title:

Multicentre randomized controlled clinical trial of acellular allogeneic dermal matrix combined with autologous skin graft for the repair of diabetic foot ulcers 

研究课题代号(代码):

Study subject ID:

2018003 

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:

唐冰 

研究负责人:

唐冰 

Applicant:

Bing Tang 

Study leader:

Bing Tang 

申请注册联系人电话:

Applicant telephone:

+86 13802502299 

研究负责人电话:

Study leader's telephone:

+86 13802502299 

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:

tangbing@mail.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

tangbing@mail.sysu.edu.cn 

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:

广州市中山二路58号 

研究负责人通讯地址:

广州市中山二路58号 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong 

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:

中山大学附属第一医院烧伤科 

Applicant's institution:

Department of Burn Surgery, the First Affiliated Hospital of Sun Yat-Sen 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:

伦审[2019]105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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-01 

伦理委员会联系人:

颜楚荣 

Contact Name of the ethic committee:

ChuRong Yan 

伦理委员会联系地址:

广州市越秀区中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Guangzhou, Guangdong 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-87780263-8221 

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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市越秀区中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

中山二路58号

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University

Address:

58 Second Zhongshan Road, Yuexiu District

经费或物资来源:

中山大学临床医学研究5010计划项目 

Source(s) of funding:

Clinical Research 5010 project of Sun Yat-Sen University 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索脱细胞异体真皮基质复合自体皮片移植修复糖尿病足溃疡的有效性和安全性。 

Objectives of Study:

To explore the efficacy and safety of acellular allogeneic dermal matrix combined with autologous skin graft in the repair of diabetic foot ulcer. 

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. 受试者签署知情同意书当天的年龄为18周岁或以上; 2. 诊断为2型糖尿病; 3. 糖尿病足溃疡持续2周或以上; 4. Wagner分级为2级或3级,如Wagner分级为4-5级行截趾/截肢术后创面需植皮者也可入选; 5. 创面面积≥3cm2; 6. 肱踝指数在0.7-1.2之间 7. 生命体征稳定,经常规检查表明可耐受手术者; 8. 患者精神状态良好、能遵循医嘱,定期复诊者; 9. 理解并愿意参加本项临床试验并提供签署的知情同意书。 

Inclusion criteria

1. The age of the subject on the date of signing the informed consent is 18 years or above; 2. Type 2 diabetes; 3. Diabetic foot ulcer lasting 2 weeks or more; 4. Wagner was rated as level 2 or level 3. If Wagner was rated as level 4-5, those who needed skin grafts after toe amputation/amputation could also be included; 5. Wound surface area: 3cm^2; 6. Brachial and malleolus index was between 0.7 and 1.2; 7. The vital signs were stable. 8. Patients with good mental state can follow the doctor's advice, regular visit; 9. Understand and be willing to participate in this clinical trial and provide signed informed consent. 

排除标准:

1. 难以控制的高血糖(如HbA1c >12.0%); 2. 患者在筛选期因潜在疾病、长期免疫抑制剂治疗或使用大剂量糖皮质激素(即每日接受≥ 40 mg泼尼松或泼尼松等量,为期≥ 2周)出现免疫抑制; 3. 合并有精神类疾病的患者; 4. 有严重未控制的疾病或全身急性感染者及合并其他严重心、肺、脑病等严重脏器疾病者; 5. 研究人员认为不宜纳入者; 6. 患者是孕妇、未采取适当的避孕措施的有生育能力的女性、在筛选期为哺乳期女性或计划在研究结束后1个月内怀孕的女性; 7. 患者在过去任何时间参加这项研究。 

Exclusion criteria:

1. Difficult to control hyperglycemia (e.g. HbA1c >12.0%); 2. Patients developed immunosuppression during the screening period due to long-term immunosuppressive treatment of underlying diseases or high doses of glucocorticoid (i.e., 40 mg prednisone or equivalent prednisone daily for 2 weeks); 3. Patients with combined mental diseases; 4. Patients with severe uncontrolled diseases or systemic acute infection or other serious heart, lung and brain diseases; 5. Those deemed unsuitable for inclusion; 6. The patient is a pregnant woman who has not taken appropriate contraceptive measures and is a lactating woman during the screening period or a pregnant woman who plans to become pregnant within 1 month after the end of the study. 7. Patients were enrolled in the study at any time in the past. 

研究实施时间:

Study execute time:

From2019-10-20To 2027-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

55

Group:

The experimental group

Sample size:

干预措施:

脱细胞异体真皮复合自体皮片移植

干预措施代码:

Intervention:

Acellular allogeneic dermis composite autologous skin graft

Intervention code:

组别:

对照组

样本量:

55

Group:

The control group

Sample size:

干预措施:

常规自体皮片移植

干预措施代码:

Intervention:

Conventional autologous skin graft?

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-Sen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

创面愈合率

指标类型:

主要指标 

Outcome:

Wound healing 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:

温哥华量表得分

指标类型:

次要指标 

Outcome:

Vancouver scale score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发率

指标类型:

主要指标 

Outcome:

The recurrence rate

Type:

Primary 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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age NA 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):

中山大学统计医学系邹华春教授,由SAS软件包生成随机号。

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

Random numbers generated by Professor Huachun Zou using SAS packages.

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

20191020

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

20191020

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:

病例记录表(Case Record Form, CRF) 或者REDCap电子采集和管理系统

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

Case Record Form, CRF or REDCap (Research Electronic Data Capture)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-19
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