A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
A Randomized, Open-label, Multicenter Clinical Trial to Evaluate the Combination Efficacy of Double-layer Artificial Dermis and Growth Factor in the Treatment of Chronic Wounds Ulcer
Double layer artificial dermis repair material has been widely used in scar plastic, burn, trauma, chronic wounds and other aspects of wound repair and reconstruction.
In the course of clinical application, we found that for chronic wounds, the combination of artificial dermis and growth factor can shorten the wound healing cycle, and have a positive impact on the economy and psychology of patients.
In order to verify this effect, we plan to carry out this study to evaluate whether double-layer artificial dermis repair material combined with growth factor treatment can improve wound closure rate and shorten closure cycle compared with single artificial dermis for chronic wound.
研究概览
研究类型
介入性
注册 (预期的)
64
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients diagnosed as chronic wounds ulcer;
- The affected limb has sufficient blood perfusion. The ankle brachial index was 0.65-1.3, or the partial pressure of oxygen was more than 40 mmHg, or Doppler ultrasound showed enough blood flow.
- After debridement, the distance between the wound and the edge of other ulcers was >2cm.
- After debridement, the area of exposed bone or tendon was >4cm2.
- The wound was completely debridement without obvious necrosis, infection control or osteomyelitis control.
- The duration of ulcer wound was at least 30 days.
- Sign the informed consent voluntarily.
Exclusion Criteria:
- Poor control of diabetes (fasting blood glucose ≥ 8.0mmol/l, HbA1c ≥ 12%);
- The researchers think that there are factors affecting wound healing, such as the use of corticosteroids, immunosuppressants and other drugs, chemotherapy or radiotherapy within one year.
- To receive or plan to receive drugs or treatment, the researchers believe that these drugs or treatment will interfere with or affect the speed and quality of wound healing;
- Unstable Charcot's foot or Charcot's joint disease with bone protrusion;
- Patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, and severe hepatopulmonary and renal diseases;
- Those who have received hyperbaric oxygen treatment within 5 days before enrollment, or who have received or plan to receive growth factor, tissue-engineered skin or other skin substitutes treatment within 30 days;
- Those who have participated in or are participating in other clinical studies within 30 days before screening;
- Pregnant, or lactating women;
- Poor general condition or other conditions not suitable for the use of double-layer artificial leather repair materials;
- Be allergic to collagen or chondroitin sulfate;
- Other cases that researchers think are not suitable for the participation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：artificial dermis with growth factor
|
artificial dermis will be used after fully debridement of the wound
growth factor
|
|
实验性的：artificial dermis only
|
artificial dermis will be used after fully debridement of the wound
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
average closure time
大体时间：From the beginning of the treatment period to the time when the survival rate of skin grafting reaches 100% or 12 weeks visit (whichever comes first), record the average time when all the subjects who reach the complete closure of the wound
|
From the beginning of the treatment period to the time when the survival rate of skin grafting reaches 100% or 12 weeks visit (whichever comes first), record the average time when all the subjects who reach the complete closure of the wound
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
total wound closure rate
大体时间：From the beginning of the treatment period to the survival rate of skin grafting reaching 100% or 12 weeks visit (whichever comes first), record the total number of patients who have reached the complete closure of the wound during this period
|
The total wound closure rate = (the number of patients who achieved complete wound closure within 12 weeks / the total number of patients in the group) * 100%.
|
From the beginning of the treatment period to the survival rate of skin grafting reaching 100% or 12 weeks visit (whichever comes first), record the total number of patients who have reached the complete closure of the wound during this period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年3月1日
初级完成 (预期的)
2022年2月28日
研究完成 (预期的)
2022年6月30日
研究注册日期
首次提交
2019年10月17日
首先提交符合 QC 标准的
2019年10月18日
首次发布 (实际的)
2019年10月21日
研究记录更新
最后更新发布 (实际的)
2019年10月21日
上次提交的符合 QC 标准的更新
2019年10月18日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
artificial dermis的临床试验
-
Michigan Institution of Women's Health PCColoplast A/S主动，不招人
-
Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester 和其他合作者终止