Topical Insulin Dressing on Management of Diabetic Foot Ulcers, Would it Help?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of diabetic foot ulcer healing
研究概览
简要总结
This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.
详细描述
Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy. It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis.
The molecular mechanisms of insulin signaling and its metabolic effects have been well studied in its classical target tissues. Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes between the age group 18-85 years.
- •Both sexes.
- •Patients who were diagnosed with diabetic foot according to the 2010 Edition of the Clinical Practice Guidelines for the Prevention and Management of Diabetes Foot Complications (edited by the American Diabetes Association) presented to diabetic foot clinic on regular basis.
- •Participants who were able to and willing to participate in the study voluntarily who could come for dressings on a daily basis, or patients who agreed for admission for the duration of treatment were included in the study.
- •Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot.
- •Patients with grade I and grade II ulcers of Wegener's Classification without significant growth of granulation tissue.
- •Patients with controlled blood glucose levels between 110 and 130 gm/dl. Hemoglobin A1c was 7.1 ± 0.
- •Non heavely infected wounds without significant growth of granulation tissue.
排除标准
- •Patients with diabetic foot ulcers of Wagner grade V.
- •X-ray showing features of osteomyelitis.
- •Duplex showing significant atherosclerotic changes and venous abnormalities like varicosities.
- •Malnutrition and uncontrolled diabetes mellitus.
- •Other clinically significant medical conditions that would impair wound healing like any hepatic, renal, immunological and neurological disease and coagulopathy.
- •Patients receiving corticosteroids, other immunosuppressive agents, radiation or chemotherapy one month prior to entry into the study.
研究组 & 干预措施
Group A (soluble insulin (Actrapid))
The ulcers were cleaned with normal saline and then irrigated with 4 units (0.1 ml) of human soluble insulin (Actrapid) in 1 ml normal saline (0.9%) for every 10 cm square of the wound.
干预措施: Insulin (Drug)
Group B (normal saline)
The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes
干预措施: Normal saline (Drug)
结局指标
主要结局
Rate of diabetic foot ulcer healing
时间窗: 12 weeks after the treatment
Rate of diabetic foot ulcer healing was recorded.
次要结局
- Need for surgical debridement(12 weeks after the treatment)
研究者
Ahmed Magdy Mohamed Ahmed
Assistant Lecturer of Vascular Surgery, Cairo University, Cairo, Egypt.
Cairo University