NCT05464407终止不适用
Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Foot ulcer healing
研究概览
简要总结
To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus
详细描述
The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes with newly diagnosed foot ulcer
- •accept study participation
排除标准
- •HbA1c >90 mmol/L
- •cognitive challenges, fx dementia
- •history with known alcohol or drug abuse
- •allergy to milk or soya
- •home less
- •critical ischemia, distal blood pressure <0.30
- •EGFR < 30
- •dialysis or planned dialysis or patients with terminal kidney insufficiency
结局指标
主要结局
Foot ulcer healing
时间窗: 12 weeks
Time to complete healing
foot ulcer area
时间窗: 12 weeks
Reduction in ulcer area of the index ulcer, cm\^2(based on height and width) within 12 weeks
次要结局
- HbA1c(12 weeks and 6 months)
- Accept of intervention(12 weeks)
- Number of foot ulcers(12 weeks and 6 months)
- Depth foot ulcer(12 weeks)
- Classifying/scoring of food ulcer(12 weeks and 6 months)
- Improvement in Quality of life(12 weeks and 6 months)
- Reduction in ulcer area(6 months)
- Compliance to intervention(12 weeks)
- Body weight(12 weeks and 6 months)
- Adverse events(12 weeks and 6 months)
- Time to complete healing of foot ulcer(6 months)
- Number of new foot ulcers(12 weeks and 6 months)
研究者
Randi Tobberup
Head of clinical dietitians, Ph.d.
Aalborg University Hospital
研究点 (2)
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