Study on the Effectiveness and Safety of Topical Human Granulocyte Macrophage Stimulating Factor Gel in the Treatment of Diabetic Wounds During the Granulation Growth Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- wound area reduction rate
研究概览
简要总结
With the aging of the population, the incidence of diseases such as diabetes, chronic atherosclerotic occlusion, cerebrovascular disease, and cancer is increasing year by year, and has led to an increasing incidence of chronic wounds such as diabetic foot, ischaemic ulcers, venous ulcers, pressure injuries, and radiation ulcers. In addition to the high age and chronic diseases that make the treatment of wounds difficult and long, chronic wounds remain in the proliferative stage, unable to carry out normal repair, which is also an important reason for the prolonged healing of wounds, which seriously affects the quality of life of patients and creates a huge social and family burden. In the United States, chronic hard-to-heal wounds exist in approximately 6.5 million people each year, costing the healthcare system more than $25 billion annually and increasing each year with the increased prevalence of diabetes and other diseases that affect wound healing. How to make chronic wounds heal quickly and well is a huge challenge that affects people's access to health today.
Macrophages are important cells involved in the inflammatory and proliferative phases of wounds, and are thought to play a key role in regulating the inflammatory response of wounds and promoting wound repair and reconstruction. Recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF), as a multifunctional haematopoietic factor, can stimulate the proliferation and differentiation of haematopoietic precursor cells to granulocyte macrophage and promote their peripheral transfer, as well as enhance phagocytosis and secretion of granulocytes and macrophages. Therefore rhGM-CSF is thought to have a possible positive role in the treatment of acute and chronic wounds and has been confirmed in several basic and clinical studies.
Topical human granulocyte macrophage stimulating factor gel (JinFuNing), which has been approved and marketed by the state for the treatment of acute and chronic wounds, is able to play a role in promoting wound repair, neovascularisation, and epithelial crawling, and has already achieved a certain degree of efficacy in promoting wound healing. This study accumulates clinical evidence-based medical evidence for more precise use of topical human granulocyte macrophage stimulating factor gel, and explores the clinical efficacy and safety of Jinfuning in the granulation growth phase of diabetic wounds.
详细描述
2. Approximately 40 people will participate in this study at the Wound Treatment Centre of Peking University Third Hospital.
3. What is included in this study? Study design: prospective, blinded evaluation, randomised controlled study; Inclusion criteria: (1) Subjects aged 18-80 years; (2) Confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard definition of the World Health Organization, with glycaemic control and glycated haemoglobin HbA1c level of less than 10% prior to enrolment; (3) Wound type belonging to the ulcer category; (4) Wound etiology belonging to the diabetic wounds, which are mainly due to the abnormalities of glucose, resulting in poor or prolonged healing, and needing to undergo standard wound treatment; (5) the wound staging was in the granulation growth phase; (6) voluntary participation in this study and signing the informed consent.
Exclusion criteria: (1) severe diseases such as acute infarction, heart failure, hepatitis, shock, and expiratory failure, which had not been corrected; (2) uncontrolled blood glucose, fasting blood glucose > 15 mmol/L and glycated haemoglobin > 12%; (3) active bleeding within the wound, which could not be carried out with the conventional basic treatment regimen; (4) serum albumin < 20 g/L; haemoglobin < 60 g/L; platelets < 50×109 /L; (5) disseminated infection status, being treated or about to be treated with antibiotics; (6) subjects with advanced malignancy; (7) active autoimmune disease; (8) previous allergy to bioactive glass ointment dressings (autogenous); (9) subjects who are unable to cooperate or mentally challenged; (10) subjects who, in the judgement of the investigator, have a clearly unremovable cause of affecting wound healing that is unsuitable for this study or unable to comply with the requirements of this study.
Randomisation to groups was based on the staging of chronic wounds and only after the stage conditions were met.
of granulation, divided into: 20 cases in the control group and 20 cases in the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard World Health Organization definition, with blood glucose controlled prior to enrolment and a glycated haemoglobin HbA1c level of less than 10%;
- •the type of wound is an ulcer;
- •the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;
- •the staging of the wound is in the granulation phase;
- •voluntary participation in the study and signing of an informed consent form.
排除标准
- •acute heart attack, heart failure, hepatitis, shock, expiratory failure and other serious diseases that have not been corrected;
- •uncontrolled blood glucose, fasting blood glucose > 15 mmol/L and glycated haemoglobin > 12%;
- •active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;
- •serum albumin < 20 g/L; haemoglobin < 60 g/L; platelets < 50 x 109/L;
- •a state of disseminated infection that is being or will be treated with antibiotics
- •patients with advanced malignant tumours;
- •active autoimmune disease;
- •previous allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning);
- •inability of the patient to co-operate or mental disorder;
- •in the judgement of the investigator, the subject has a clearly irremovable cause of wound healing, is unsuitable for the study or is unable to comply with the requirements of the study.
研究组 & 干预措施
Topical Human Granulocyte Macrophage Stimulating Factor Gel
The diabetic wounds were treated with Topical Human Granulocyte Macrophage Stimulating Factor Gel for 2 weeks on top of the standard clinical treatment protocol.
干预措施: Topical Human Granulocyte Macrophage Stimulating Factor Gel (Drug)
saline
The diabetic wounds were treated with saline for 2 weeks on top of the standard clinical treatment protocol.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
wound area reduction rate
时间窗: From enrollment to the end of treatment at 2 weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
次要结局
- wound healing rate(From enrollment to the end of treatment at 2 weeks)
- Granulation tissue status(From enrollment to the end of treatment at 2 weeks)
- wound infection control(From enrollment to the end of treatment at 2 weeks)
研究者
Long Zhang
Head of Wound Healing Center
Peking University Third Hospital