Effect of topical insulin on diabetic wound healing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Topical insulin dressings over the routine saline dressings by comparing percentage reduction in the surface area of the ulcer.
研究概览
简要总结
Patients with diabetic foot ulcers who present to the outpatient department are considered for the study. Once patients willing for the study, randomisation will be done by using coloured envelope method. Blue envelope for Group A(Intervention group), pink envelope for Group B(control group).
The ulcers are first washed with saline. The ulcer will be then examined and based on inclusion and exclusion criteria, they will be taken into study either on admission basis or on Outpatient Department basis , depending upon the patient.
Appropriate history will be taken and measurements of ulcer will be documented using a paper ruler. The wound size will be calculated by taking the longest diameter (a) in cm, and multiplying with its perpendicular diameter (b) so that, area of the wound is obtained in cm2.
Based on their randomisation group patients will receive dressing.
Group A will receive dressing with insulin using 0.4units per cm2 of the wound. The solution will be sprayed over the surface of ulcer with a syringe.
Group B will receive dressing with normal saline. This is a standard of care for treating a diabetic ulcer.
The wound will be dressed and assessed on day0, day 3, day 6, day 9, day 12 and day 15 in both the groups.
This study will not affect patient’s systemic antibiotic therapy.
Care will be taken that these admissions are for periodic dressings and not for other health reasons. It will be made clear to the patients that their stay is not merely for the sake of study. The concerned patient’s physician is informed about the additional insulin doses and RBS levels in case there is a fluctuation during the course of study in order to adjust regular insulin accordingly.
The study does not involve blinding of participants and investigator. GRBS will be done half an hour prior to the dressing as a part of treatment protocol. This GRBS test will be done using the procured glucometer and strips.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients with diabetic ulcers (both type 1 & type 2) in lower limbs.
- •â€¢Patients who are above 18 years of age •Patients with ulcer area of ≤ 30cm
- •â€¢Patients with Grade 0, 1 and Stage A, C according to University of Texas Diabetic Wound classification.
- •â€¢Patients who are willing to participate in study voluntarily.
排除标准
- •â€¢ Patients with Grade 2, 3 and Stage B, D according to University of Texas Diabetic wound classification.
- •â€¢ Burns wounds and Pressure sores • Patients with venous ulcers.
- •â€¢ Patients more than 70 years old.
- •â€¢ Patients on systemic steroid therapy or immune-compromised patients.
- •â€¢ Non compliant patients.
- •â€¢ Patients with GRBS <100 mg/dl before the dressing.( Safety check) • Pregnant female patients.
结局指标
主要结局
To evaluate the effect of Topical insulin dressings over the routine saline dressings by comparing percentage reduction in the surface area of the ulcer.
时间窗: 15 days
次要结局
- To evaluate the efficacy of Topical insulin application on reducing the wound healing time by comparing the time taken for the ulcer to decrease in size.(15 days)