Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of blood vessels
研究概览
简要总结
Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
详细描述
Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nondiabetic patients with full-thickness acute wounds
排除标准
- •Diabetic patients
研究组 & 干预措施
Insulin
Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized.
干预措施: Insulin (Drug)
Placebo
Half of the wound surface was treated daily with normal saline. Allocation was randomized.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of blood vessels
时间窗: 14 days
In a biopsy taken at baseline, blood vessels will be counted
次要结局
- Hypoglycaemia(14 days)
研究者
MARIO AURELIO MARTÍNEZ-JIMÉNEZ
General Surgeon
Hospital Central "Dr. Ignacio Morones Prieto"