NCT00711217已完成3 期
Evaluation of a Medical Food for Chronic Wounds
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 99
- 主要终点
- Wound healing
研究概览
简要总结
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-pregnant
- •neuropathic foot ulcer
- •ABI> 0.7
排除标准
- •uncontrolled DM
- •collagen vascular disease or autoimmune disease
- •wound infection; recent therapies with steroids
- •growth factor or bioengineered tissue
- •radiation therapy
- •treatment with antibiotics within 1 week, Charcot's arthropathy of the foot
- •active malignancy
- •renal function impairment
- •liver failure
- •planned surgery
- •myocardial infarction within 3 months
- •malnutrition
- •substance abuse
- •taking conflicting oral nutritional supplements
研究组 & 干预措施
#1 Medical food
Experimental
干预措施: Medical Food (Other)
#2 Control
Placebo Comparator
干预措施: Drink mix calorically similar to experimental product (Other)
结局指标
主要结局
Wound healing
时间窗: 16 weeks
次要结局
- QOL(16 weeks)
- Wound healing measures(16 weeks)
- Incidence of complications(16 weeks)
- Clinical outcome data(16 weeks)
研究者
研究点 (99)
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