A RANDOMIZED CONTROL STUDY IN ASSESSING HEALINGRATE USING COLLAGEN SILVER GEL VERSUSCONVENTIONAL DRESSING IN MANAGEMENT OFDIABETIC FOOT ULCER
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Reduction in pain using Visual analogue and over all Healing of the Wound
研究概览
简要总结
All patients fulfilling the inclusion criteria will be enrolled for the study. Informed consent will be taken to participate in the study. Cases will be randomized into two groups (odd and even). In the first group, dressing will be done with collagen silver gel. In the second group, dressings will be done with povidone iodine.
Group 1: Under all aseptic precautions wound debridement will be done, cleaned with normal saline. Then collagen silver gel will be applied which will then be covered by gauze and roller bandage. The wound will be inspected on 3rd, 7th, 10th and 15thday and compared with that of group 2 in the form of signs of healing, decrease in size, discharge and granulation tissue/epithelisation.
Group 2: In this group, patients will be treated with the conventional method of dressing with povidone iodine followed by dressing with gauze pad and bandage. The wound will be inspected on 3rd, 7th, 10th and 15th day. Visual analysis of all the parameters will be recorded in a proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All diabetic patients with Wagner criteria greater than 2
- •Subjects willing to Sign Informed Consent Document.
排除标准
- •1.Previous interventions 2.Bedsores 3.Vascular ulcers.
结局指标
主要结局
Reduction in pain using Visual analogue and over all Healing of the Wound
时间窗: Days 3,7,10 and 15
次要结局
- Over all safety and Adverse Events(Days 3,7,10 and 15)