The Efficacy of Local Insulin Injection Vs Conventional Normal Saline Dressing in Diabetic Foot Ulcer Management: A Randomized Control Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The percentage reduction of wound size in Group A is 79.7 % and the Percentage reduction in Group B is 40.84 %
研究概览
简要总结
**Title of the dissertation,**The Efficacy of Local Insulin Injection vs Conventional Normal Saline Dressing in Diabetic Foot Ulcer Management: A Randomized Controlled Study.
In this study, we are using local insulin and comparing it with normal saline dressing in diabetic foot ulcers, to find out which of the above dressing enhances wound healing.
Objectives are To Compare the effect of Local insulin Injection and conventional normal Saline dressing on healing of diabetic foot ulcer and To identify the factors associated with wound healing among the patients with diabetic foot ulcer.
Study settingsTertiary care hospital, in Pondicherry, 740 bedded hospital, NABH, NABL, NAAC Accredited.
Sample size is 64, 32 in each arm. After applying inclusion and exclusion criteria and after getting consent,
Group A, from the total dose of short acting insulin (Human Actrapid) required for the patient (per day) half of it is diluted with 1 ml sterile water and injected into the base of the wound with 1 ml syringe, and the remaining half of the requirement is injected subcutaneously in the anterior abdominal wall, daily for 10 days.
Group B, full calculated dose of insulin will be given subcutaneously in the anterior abdominal wall and wound dressing will be done using normal saline.
Ulcer evaluation will be done by measuring ulcer area using a Transparent graph sheet, slough area is marked separately
Wound healing is observed by measuring the ulcer size, depth, and presence of granulation tissue every week for 3 week.
Analysis is done by comparing the rate of regression of wound size between the two groups.
Wound healing and slough reduction is compared between the two groups
The rate of regression of wound size, slough reduction, and presence of granulation tissue will be measured in day one and 7th, 14th and 21st day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic foot ulcer with Grade 2 of Wagner Meggit classification 2) Age More than 18 years.
排除标准
- •Patient in sepsis 2) Immunocompromised patient.
- •HIV, HBsAg, HCV, and another disease that requires steroids as treatment. 3) Patient with renal failure 4) Patient with Severe Anemia.
结局指标
主要结局
The percentage reduction of wound size in Group A is 79.7 % and the Percentage reduction in Group B is 40.84 %
时间窗: The rate of regression of wound size, slough reduction, and presence of granulation tissue will be measured in day one and 7th, 14th and 21st day
次要结局
- To identify the factors associated with wound healing among the patients with diabetic foot ulcer.(The rate of regression of wound size, slough reduction, & presence of granulation tissue will be measured in day one & 7th, 14th & 21st day)
研究者
PRASSANNA RAJU
PONDICHERRY INSTITUTE OF MEDICAL SCEINCES