Effect of Local Insulin Injection on Wound Healing in Patients with Diabetic Foot Ulcer.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- -Surface Area of the wound that is increasing or decreasing.
研究概览
简要总结
This study is randomized parallel group single centre trial to study the effects of local insulin injection in wound healing in patients with diabetic foot ulcer that will be conducted in Adesh institue of medical sciences and research in india. The primary outcome measures will be the surface area of wound that is increasing or decreasing, amount of exudate from wound and type of exudate whether it is foul smelling pus or serous fluid or serosanguinous discharge or haemorrhagic, granulation tissue whether it is healthy red or pale yellow or white or necrotic, time duration required in healing of wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who were diagnosed with diabetic foot ulcer.
- •Patients who are already on injectable insulin therapy subcutaneously with OHAs 3.voluntary participants with more than 18years who were able and willing to participate in the study 4.patients with relatively stable blood glucose levels, without the influence of diet, exercise, infection, stress or other factors that could affect systemic blood glucose 5.wounds without significant growth of granulation tissue.
- •Grade 2 and grade 3 ulcer according to European pressure ulcer classification.
排除标准
- •Patients with osteomyelitis, immunodeficient , varicose ulcer , patients with liver disease, kidney disease, skin malignancy and patients on chemotherapy or radiotherapy.
- •Patients with Hepatitis B , HCV or HIV positive.
结局指标
主要结局
-Surface Area of the wound that is increasing or decreasing.
时间窗: •Assessment of exudate, appearance of granulation, disappearance of slough , reduction in wound size will be seen on day 1,day 4 day 7 , day 14 and 21 between groups receiving insulin and saline dressing.
-Amount of Exudate from Wound and the type of Exudate whether it is foul smelling pus or serous fluid or serosanguinous discharge or Haemorrhagic.
时间窗: •Assessment of exudate, appearance of granulation, disappearance of slough , reduction in wound size will be seen on day 1,day 4 day 7 , day 14 and 21 between groups receiving insulin and saline dressing.
-Granulation tissue whether it is healthy red , Pale Yellow ,White or Necrotic.
时间窗: •Assessment of exudate, appearance of granulation, disappearance of slough , reduction in wound size will be seen on day 1,day 4 day 7 , day 14 and 21 between groups receiving insulin and saline dressing.
-Time duration required in healing of wound.
时间窗: •Assessment of exudate, appearance of granulation, disappearance of slough , reduction in wound size will be seen on day 1,day 4 day 7 , day 14 and 21 between groups receiving insulin and saline dressing.
次要结局
未报告次要终点
研究者
Dr Anupriya
Adesh Institute of Medical Sciences and Research