A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Decrease area of wound healing due to Diabetic Foot Ulcer
研究概览
简要总结
Purpose and significance:With the increasing incidence of Diabetes mellitus (DM), the incidence rate of Diabetic Foot (DF) is raised. DF is a foot infection, ulceration and / or deep tissue destruction caused by nerve abnormalities and varying degrees of vascular lesions in DM patients. The high incidence, disability and mortality rate of DF make it urgent to explore new ways to improve the cure rate, reduce the burden and elevate the quality of life. Previous studies have confirmed that traditional Miao ethic medicine Tangningtongluo(TNTL) can improve the remission rate of diabetes mellitus and diabetic foot disease, but the clinical research evidence is not sufficient. This study aims to provide effective clinical evidence for the treatment of diabetic foot patients with TNTL by observing growth rate of wound, prognosis and outcome.
Methods: From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
Type of study: randomized controlled, prospective,intervention study.
详细描述
From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 2 diabetes mellitus
- •Clinical diagnosis of Diabetic Foot Ulcer
排除标准
- •Type 1 diabetes mellitus(T1DM), special type of diabetes, gestational diabetes mellitus, drug-induced hyperglycemia
- •TNTL allergy
- •Chronic kidney failure（eGFR≤30ml/min/1.73cm2）, severe liver function damage (transaminase ≥ 3 times the normal value), acute or chronic pancreatitis, autoimmune disease, malignant tumors
- •Recent acute complications of type 2 diabetes mellitus（ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis etc.）or other emergency situations
- •History of using glucocorticoids and immunosuppressants
- •Mental illness and cognitive dysfunction or poor compliance, unable to take medication as required
- •Malignant ulcer
研究组 & 干预措施
Standardized Western Medicine Treatment Group
All participants undergo a similar treatment protocol for the diabetic foot, based on the Infectious Diseases Society of America (IDSA).
干预措施: Standardized Western Medicine Treatment (Drug)
Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group
Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing.
干预措施: Standardized Western Medicine Treatment (Drug)
Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group
Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing.
干预措施: Tangningtongluo tablet and cream (Drug)
Standardized Western Medicine Treatment +TNTL tablet Group
Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day.
干预措施: Standardized Western Medicine Treatment (Drug)
Standardized Western Medicine Treatment +TNTL tablet Group
Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day.
干预措施: Tangningtongluo tablet (Drug)
Standardized Western Medicine Treatment +TNTL cream Group
Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing.
干预措施: Standardized Western Medicine Treatment (Drug)
Standardized Western Medicine Treatment +TNTL cream Group
Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing.
干预措施: Tangningtongluo cream (Drug)
结局指标
主要结局
Decrease area of wound healing due to Diabetic Foot Ulcer
时间窗: 12 weeks
Assessment the decrease of whole area of diabetic foot ulcers. The unit is square centimeters .
Decrease of depth of ulcer involve the deep fascia.
时间窗: 12 weeks
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
Amputation Rate
时间窗: 12 weeks
The difference of end-stage amputation rates between the experimental group and the control group were evaluated by the arterial and venous blood circulation of the lower limbs
Diabetic Foot Ulcer relapse rate
时间窗: 12 weeks
The relapse of Diabetic Foot Ulcers is a common complication in the advanced stage of DFU. The difference of treatment between the experimental group and the control group indicates that the prognosis is variability.
次要结局
- Fasting glucose(12 weeks)
- 2-H postload glucose(12 weeks)
- BMI Index(12 weeks)
- WHR Index(12 weeks)
- Islet B cell function(12 weeks)
- interleukin-6(IL-6)(12 weeks)
- tumour necrosis factor-α(TNF-α)(12 weeks)
- C-reactive protein(CRP)(12 weeks)