Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time of healing
研究概览
简要总结
Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population
排除标准
- •Manifestation of hypersensitivity to any component of the product
- •Uncooperative patients
- •Severe infection
- •Debilitating diseases
- •Steroid treatment
- •Pregnancy
研究组 & 干预措施
DIAMEL
Study group that receives the active product.
干预措施: DIAMEL (Dietary Supplement)
Placebo
Control group receiving double-blind placebo.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Time of healing
时间窗: 1 year
The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.
次要结局
- Glycemic control(1 year)
- Insulin control(1 year)
- Lipidic control(1 year)
- Body mass control(1 year)
- Renal function control(1 year)