Effect of Insulin on Wound Healing- A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 主要终点
- Area of wound healing
研究概览
简要总结
A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.
详细描述
This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics.
The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing.
All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Texas 1 and 2 wound criteria
排除标准
- •Texas 3 and 4 wound criteria
研究组 & 干预措施
Intervention
Before starting the therapeutic procedure, all wounds will be fully washed with normal saline.
Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily.
The patients in this arm will receive conventional therapy.
干预措施: Insulin (Drug)
Control
Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin
干预措施: Insulin (Drug)
结局指标
主要结局
Area of wound healing
时间窗: 4 months
Rate of wound healing will be calculated as the difference between the primary and final wound area in mm as a function of healing time (in days) and reported as mm/day.
次要结局
未报告次要终点
研究者
Abeer AlSaweer
Central Diabetes clinic coordinator in PHC
Ministry of Health, Bahrain