NCT04372355已完成2 期
Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c change at Week 8 in comparison to Baseline
研究概览
简要总结
Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who will receive standard wound treatment in combination with adjuvant therapy WF10 to compare the change of HbA1c levels at baseline and after treatment.
详细描述
Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients diagnosed with Diabetes Mellitus type II
- •Patient male or female 18-80 years old
- •Presence of Diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4
- •HbA1c > 8.5%
- •Hematocrit > 30%
排除标准
- •Kanofsky performance status < 60
- •Patient with ABI (Ankle Brachial index) < 0.4
- •Patient who receive steroid ,chemotherapeutic drug
- •Pregnant or lactating woman
- •Patient had a history of organ transplantation, and using immunosuppressive drug
- •Patient with end-stage renal disease requiring hemodialysis, or history of G6PD or severe thalassemia, or ischemic heart disease, Congestive heart failure, Heart arrhythmia
- •Patient who is participating in another clinical study or have done it in the past 30 days.
研究组 & 干预措施
Chlorite-based drug WF10
Experimental
WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five
干预措施: WF10 (Drug)
结局指标
主要结局
HbA1c change at Week 8 in comparison to Baseline
时间窗: 8 weeks
The mean change of HbA1c values between Baseline (Week 0) and Week 8 after the initial WF10 treatment
次要结局
- HbA1c change at Week 12 in comparison to Baseline(12 weeks)
研究者
Narongchai Yingsakmongkol
Associate Professor
Srinakharinwirot University
研究点 (1)
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