The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- ulcer area
研究概览
简要总结
Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. In preliminary clinical practice, Huafu Shengji Ointment has been shown to significantly improve the complete healing rate of ulcer wounds. This study aims to further comprehensively evaluate the therapeutic effects of Huafu Shengji Ointment and provide high-quality evidence.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria will be included:
- •Patients who meet the diagnostic criteria for diabetic foot and have a Wagner grade of 1-
- •It is in line with the syndrome type of qi deficiency and blood stasis in traditional Chinese medicine.
- •Age between 35 and 80 years
- •The patient had no serious cardiac, liver, renal insufficiency or other systemic infections.
- •No hereditary or infectious diseases, no malignant tumors, and no severe malnutrition in patients.
- •Have understood the treatment modality and voluntarily signed the informed consent form.
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Patients who experience severe allergic reactions to the experimental medication and cannot undergo treatment.
- •Patients with poorly controlled serious conditions such as diabetic ketoacidosis, ketoacidosis, or diseases of the liver and kidneys.
- •Patients with psychiatric disorders or severe depression.
- •Women who are pregnant or breastfeeding.
- •Patients with severe organic tumors.
研究组 & 干预措施
Huafu Shengji Ointment
After debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.
干预措施: Huafu Shengji Ointment (Drug)
ethacridine lactate solution
After debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.
干预措施: ethacridine lactate solution (Drug)
结局指标
主要结局
ulcer area
时间窗: Measured once a week, for a total of 8 weeks.
Method of measuring ulcer area: Sterile transparent dressings are used to trace the edges of the ulcer, digital cameras are used to capture the images, and ImageJ is utilized for analysis and processing.
ulcer volume
时间窗: Measured once a week, for a total of 8 weeks.
Ulcer volume measurement method: After debridement is completed, the wound surface is dried with a dry cotton ball. Sterile saline is injected into the ulcer cavity using a sterilized syringe until the liquid level is flush with the skin. When the ulcer is a fistula, one end of the fistula is sealed with sterile transparent film, and then saline is injected. The volume of the injected saline is equivalent to the volume of the ulcer.
the time of complete wound healing
时间窗: complete wound healing (assessed up to 8 weeks)
Digital cameras capture images, documenting the process of wound from the ulcerative state to the complete in situ healing of the skin tissue.
granulation tissue coverage
时间窗: Measured once a week, for a total of 8 weeks.
Granulation tissue area coverage rate = (Area of the wound covered by granulation tissue \[mm\^2\]) / (Total wound area \[mm\^2\]) × 100%
次要结局
- the degree of pain(Measured once a week, for a total of 8 weeks.)
- urea nitrogen(Measured once a week, for a total of 8 weeks.)
- alanine aminotransferase(Measured once a week, for a total of 8 weeks.)
- the skin temperature around the wound(Measured once a week, for a total of 8 weeks.)
- the extent of wound exudate(Measured once a week, for a total of 8 weeks.)
- electrocardiogram(Measured once a week, for a total of 8 weeks.)
- skin color(Measured once a week, for a total of 8 weeks.)
- aspartate aminotransferase(Measured once a week, for a total of 8 weeks.)
- serum creatinine(Measured once a week, for a total of 8 weeks.)
研究者
Yu Cai
Attending Physician
Beijing Daxing District Hospital of Integrated Chinese and Western Medicine