Foryou NPWT: 华励负压伤口治疗系统

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  • 前瞻、多中心评价Foryou负压设备促进糖尿病下肢溃疡愈合安全性有效性
  • 2012-11-19

  • http://www.chictr.org.cn/

    注册号:
    Registration number:

    ChiCTR-TRC-12002700 

    注册号获得时间:
    Date of releasing the registration number:

    2012/11/19 

    注册号状态:

    预注册 

    Registration Status:

    Prospective registration 

    注册题目:

    前瞻、多中心评价 foryou 负压吸引设备促进糖尿病下肢溃疡愈合安全性有效性 

    Public title:

    A Prospective Multicenter Assessment of Foryou NPWT Security and Effectiveness in Promoting the Healing of Diabetic Foot Ulcer 

    研究课题的正式科学名称:

    前瞻、多中心评价 foryou 负压吸引设备促进糖尿病下肢溃疡愈合安全性有效性 

    Scientific title:

    A Prospective Multicenter Assessment of Foryou NPWT Security and Effectiveness in Promoting the Healing of Diabetic Foot Ulcer 


    申请注册联系人:

    郑灿阳 

    研究负责人:

    薛耀明 

    Applicant:

    Zheng Canyang 

    Study leader:

    Xue Yaoming 

    申请注册联系人传真
    Applicant Fax

    +86 0752 5300666 

    研究负责人传真:
    Study leader's fax:

    +86 020 87282018 

    申请注册联系人电子邮件
    Applicant E-mail

    Cyrus@ForyouNPWT.com 

    研究负责人电子邮件:
    Study leader's E-mail:

    yaomingxue@126.com 

    申请单位网址:
    Applicant website:

    www.ForyouNPWT.com

    申请注册联系人通讯地址:

    广东省惠州市东江高新产业园上霞北路1号 

    研究负责人通讯地址:

    广州市广州大道北1838号南方医院内分泌代谢科 

    Applicant address:

    No. 1, North Shangxia Road, Dongjiang Hi-tech Dist., Huizhou City, Guangdong,China 

    Study leader's address:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Guangzhou Dadao Bei No 1838, Guangzhou, Guangdong 

    申请人所在单位:

    惠州市华阳医疗电子有限公司 

    Applicant's institution:

    Foryou Medical Electronics Co, Ltd. 


    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:

    [2012]伦审字(068)号 

    批准本研究的伦理委员会名称:

    南方医科大学南方医院医学伦理委员会 

    Name of the ethic committee:

    Ethical Committee of Nanfang Hospital, Southern Medical University 

    伦理委员会批准日期:
    Date of approved by ethic committee:

    2012/07/25 

    研究实施负责(组长)单位:

    南方医科大学南方医院内分泌代谢科 

    Primary sponsor:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University 

    研究实施负责(组长)单位地址:

    广州市广州大道北1838号南方医院内分泌代谢科 

    Primary sponsor's address:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, 1838 Guangzhou Dadao Bei, 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):南方医院

    具体地址:

    广州市广州大道北1838号南方医院内分泌代谢科

    Institution hospital:Nanfang Hospital

    Address:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Guangzhou Dadao Bei No 1838, Guangzhou, Guangdong


    经费或物资来源:

    惠州市华阳医疗电子有限公司 

    Source(s) of funding:

    Foryou Medical Electronics Co, Ltd. 

    研究疾病:

    糖尿病足溃疡 

    Target disease:

    Diabetic Foot Ulcers 

    研究类型:

    干预性研究 

    Study type:

    Interventional 

    研究所处阶段:

    I期临床试验 

    Study phase:

    Phase I 

    研究目的:

    A. 评价foryou负压吸引设备促进糖尿病下肢溃疡愈合的的安全性 B. 评价foryou负压吸引设备促进糖尿病下肢溃疡愈合的的有效性 

    Objectives of Study:

    A. Assessment of safty of Foryou NPWT in Promoting the Healing of Diabetic Foot Ulcer B. Assessment of effect of Foryou NPWT in Promoting the Healing of Diabetic Foot Ulcer 

    研究设计:

    随机平行对照 

    Study design:

    Randomized parallel control 

    纳入标准:

    1) 患者有1型或2型糖尿病; 2) 糖尿病下肢溃疡(DFUs)包括糖尿病患者的截肢后伤口,由本研究的研究者判断创面适合使用NPWT治疗; 3) 溃疡面积为3-10 cm2,并且溃疡创面存在一周以上; 4) 年龄在18-80岁,男女不限; 5) 患者创面局部血供良好(踝肱指数≥0.7且≤1.2); 6) 理解并签署知情同意书; 

    Inclusion criteria

    1) Patients with type I diabetes mellitus or type II diabetes mellitus; 2) Patient with diabetic foot ulcers (DFUs) including amputation wound is suitable for NPWT by the researcher of this study; 3) The wound area of the ulcer is 3-10 cm2 and has been there for more than a week; 4) Patient between the age of 18 to 80; both gender; 5) Good blood circulation on part of the wound bed (0.7≦ABI≦1.2); 6) Understand and sign the informed consent. 

    排除标准:

    1) 存在严重肝肾功能障碍(GPT>2倍正常值上限,Cr>2倍正常值上限)或血糖控制不理想(糖化血红蛋白Hb1Alc>12%); 2) 患者存在严重低蛋白血症(血清总蛋白TP低于60g/L)或贫血(Hb<100g/L) 3) 未经控制的骨髓炎或蜂窝组织炎; 4) 治疗创面或创面边缘怀疑存在恶性肿瘤; 5) 创面局部存在未暴露的瘘管,在受试者入选时伤口创面还需要进一步清创处理; 6) 创面局部主要的血管,器官或神经已经暴露; 7) 创面局部存在不能控制的活动性出血 8) 由于溃疡部位等原因难以保持真空,技术上预期难以成功; 9) 治疗创面在入选前的48小时内接受过NPWT治疗; 10) 患者纳入本研究之前2周内接受过生长因子,高压氧、热疗或真空辅助闭合治疗; 11) 目前或3个月之内接受过化疗或放射治疗; 12) 已知对敷料材料高度敏感; 13) 预期患者对于临床观察计划依从性差; 14) 患者怀孕; 15) 患者目前或既往30天内正在参加其他临床试验(无论是器械还是药物)。 

    Exclusion criteria:

    1) Patient with severe hepatic and renal dysfunction(GPT>2xULN, Upper Limits of Normal; Cr>2xULN) or unsatisfactory control of blood sugar(Hb1A1c>12%); 2) Patient with severe hypoproteinemia(TP<60g/L) or anemia(Hb<100g/L); 3) Patient with uncontrolled osteomyelitis or cellulites; 4) Malignancy is suspected in or at the edge of the wound bed; 5) Unexposed fistula in part of the wound bed needs to be debrided after the patient is selected; 6) Patient with exposed major vascular, organs or nerves in part of the wound bed; 7) Incontrollable active bleeding in part of the wound bed; 8) Technically it is difficult to succeed if the wound can not be vacuum; such problem may due to the ulcer area or other reason; 9) Patient has already had NPWT experience in the early 48 hours before he is selected; 10) Patient has already treated by growth factor, hyperbaric oxygen therapy, thermal therapy or Vacuum Assisted Closure before he is selected; 11) Patient under Chemotherapy or radiation therapy, or has been treated by these therapies in the past three months; 12) Patient is highly sensitive to foam dressing material; 13) Patient’s non-compliance with clinical observation plan is expected; 14) Patient is pregnant; 15) Patient under other clinical experiment, or has been tested by other experiment in the past thirty days (experiment by device or medicine). 

    研究实施时间:
    Study execute time:

    From 2012-8-1 To 2013-8-1 

    干预措施:
    Interventions:

    组别:

    A

    样本量:24

    Group:

    A

    Sample size:24

    干预措施:

    foryou负压吸引设备的负压伤口治疗

    干预措施代码:

    Intervention:

    Negative Pressure Wound Therapy

    Intervention code:

    组别:

    B

    样本量:24

    Group:

    B

    Sample size:24

    干预措施:

    高级伤口敷料治疗

    干预措施代码:

    Intervention:

    Advanced Wound Dressing Treatment

    Intervention code:

    研究实施地点:
    Countries of recruitment and research settings:

    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):南方医院 

    单位级别:

    三级甲等公立医院 

    Institution
    hospital:Nanfang Hospital 

    Level of the institution:

    Third Grade Class A 

    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):广东省人民医院 

    单位级别:

    三级甲等 

    Institution hospital:Guangdong General Hospital 

    Level of the institution:

    Third Grade Class A 

    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):广州市第一人民医院 

    单位级别:

    三级甲等 

    Institution hospital:Guangzhou First Municipal People's Hospital 

    Level of the institution:

    Third Grade Class A 

    测量指标:
    Outcomes:

    指标中文名:

    糖尿病下肢溃疡创面面积的变化

    Outcome:

    The change in wound area of diabetic foot ulcer over a 4-week period

    指标中文名:

    糖尿病下肢溃疡创面完全愈合率

    Outcome:

    To assess complete healing rate of diabetic foot ulcer over a 4-week period;

    指标中文名:

    糖尿病下肢溃疡创面完全愈合所需时间

    Outcome:

    To measure time required to complete healing of diabetic foot ulcer;

    指标中文名:

    治疗过程中的所有不良事件

    Outcome:

    To record all adverse events in the treatment.


    采集人体标本:

    Collecting sample(s)
    from participants:

    标本中文名:

    伤口渗出液

    Sample Name:

    exudate

    人体标本去向

    使用后销毁

    Fate of sample:

    Destruction after use

    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
    最大
    Max age
    80

    性别
    Gender

    男女均可
    Both


    随机方法(请说明由何人用什么方法产生随机序列):

    按中心分层,用SAS9.2统计软件编程,采用分层区段随机化方法,给定种子数和区段长度,产生随机编码表。

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

    Stratified by center (hospital), programmed by SAS9.2 software. In according to stratified blocked r


    盲法:

    开放设计

    Blinding:

    Opening Design

    资料收集汇总单位:

    南方医科大学南方医院内分泌代谢科

    Data collection Institution:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University

    资料管理单位:

    南方医科大学南方医院内分泌代谢科

    Data management Institution:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University

    资料分析单位:

    南方医科大学南方医院内分泌代谢科

    Data analysis Institution:

    Dept. of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University

    创建人:
    Creater Name:

    郑灿阳 2012/9/3 13:22:57