Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 主要终点
- The re-operation rate
研究概览
简要总结
Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors leading to limb amputation, it was reported that the amputation rate is 15 times of the non-diabetic patients. Common surgical amputation is not only about high plane amputation but also bring a tremendous mental stress to patients which may affect the quality of life seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia , and septic shock which could be the main cause of death before amputation. It become an important topic that how to control the infection, reduce the amputation plane, save the function as possibility, and improve the life quality of the patients as well.
This study is based on years of clinical experience of and brings out "early-stage amputation" concept firstly in China with a systematic exposition, experimental research and clinical research. Early-stage amputation refers to cut in the normal tissue from the inflammatory tissue at the junction line of limbs, in order to achieve more retained stump, block endotoxin absorption and improve the quality of life of patients. External therapy of herbs chitosan can promote granulation tissue regeneration and control of local infection, it solved the problem of difficult wound healing and it is a reliable guarantee of early-stage amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to Chinese herbs medicine standard for the diagnosis and treatment of diabetic foot, the individual diagnosed as diabetic foot with acromelic gangrene.
- •The individual aged between 18 and 70 years.
- •All wounds corresponded to Wagner classification grade 4 or
- •By appropriate treatment, skin temperature of limb with ulcer became warmer and it proved that the blood circulation recovery could be happening.
- •There were no obvious bruises or chromatosis in the necrosis skin.
- •Persistent limb pain affected the sleep of the individuals.
- •The individual voluntarily signed the informed consent form.
排除标准
- •Acromelic gangrene caused by other reasons.
- •The individuals with server cardiovascular and cerebrovascular diseases or hepatic and kidney diseases do not adhere to surgery.
- •The individuals with the history of amputation.
- •The individuals with systemic inflammatory response syndrome, Bacteremia, Pyemia or shock.
- •Vascular ultrasound shows artery is completely blocked.
- •The individuals do not adhere to the treatment or are with other treatments.
结局指标
主要结局
The re-operation rate
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Because of diabetic foot ulcer individual was given a re-operation.
Grades of wound healing
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
As wound healing, wound healing was assessed using 1 to 3 healing grades.
次要结局
- SF-36(7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.)
- Healing time(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.)
- Amputation level(At time of surgery.)
- The rate of infection(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.)
- Trinity amputation and prosthesis experience scale (TAPES)(7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.)
研究者
Wang Kuanyu
Director of Department of Surgery, First Affiliated Hospital of Heilongjiang UCM
Heilongjiang University of Chinese Medicine