NCT03813927已完成不适用
Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Wound healing
研究概览
简要总结
The purpose of this study, is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.
详细描述
Project title
"Treatment with oral vitamin D in diabetic patients with chronic foot ulcers on the lower limb; a clinical controlled study of the effect on wound healing".
Abstract
Aims and objectives
The purpose of this study is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Diagnosed diabetes.
- •Foot ulcers more than 6 weeks.
- •Informed consent
排除标准
- •Granulomatous diseases such as tuberculosis, sarcoidosis and silicosis
- •Hypercalcemia
- •Supplementation of vitamin D > 20 μg a day
- •Renal disease
- •Liver disease
- •Osteomyelitis
- •Skin cancer.
- •High blod pressure (> 150/100 mmHg).
- •Indication for surgical revision.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo, tablet with 20 μg Vitamin D each day.
干预措施: Placebo (Dietary Supplement)
Vitamin D
Experimental
supplementation with tablet 170 μg Vitamin D each day.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Wound healing
时间窗: 48 weeks or wound healing.
Wound healing, measured in square cm
次要结局
- Vitamin D blod level status(48 weeks or wound healing.)
研究者
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