An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants With Limb Salvage
研究概览
简要总结
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.
Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well Controlled diabetic state
- •Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
- •Good glycaemic control
排除标准
- •Pregnant women and women at risk of conception
- •Patients taking digitalis glycosides
- •Patients with abnormal liver function tests
- •Patients with plasma creatinine great then 150 umol/l or unstable renal function
- •Poorly controlled Diabetes Mellitus
- •Uncontrolled infection
- •History of adverse reaction to herbal medicine
- •Unstable medical conditions
- •Non-compliance with regime
研究组 & 干预措施
Traditional Chinese Medicine
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
干预措施: TCM (Drug)
Placebo
Placebo was made with starch and colouring materials. Given to patient orally twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Limb Salvage
时间窗: 24 weeks
The number of successful limb rescued (without amputation).
次要结局
- Tumour Necrosis Factor-alpha Levels in Serum(Baseline and 4 week)
- Time of Ulcer Healing(24 week)