A new topical gel using combination of Colloid Silver Nanoparticles, Aloe Gel and Chitosan for treatment of ucler in diabetic patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Faster granulation tissue formation and Faster wound healing
研究概览
简要总结
This is a randomized parallel group, single center open study comparing the conventional amorphous hydrogel and a Novel Topical Gel Formulation Comprising Colloidal Silver Nanoparticles, Aloe Vera Gel, and Chitosan for treatment of ulcers in diabetic patients. The composition of the Novel topical gel are of 25gm of CMC gel and 25gm of carbopol gel mixed using a homogenizer and 5ml of AgNCs+ Aloe vera gel solution added to it. A total of 40 patients are to be included in the study. Primary outcome of the study is faster wound healing and early appearance of granulation tissue. Day 3, 7 and 14 are the time points and photographic evidence is used to assess response to treatment. Secondary outcomes are reduced infection rates, decreased inflammation, enhanced moisture management, enhanced patient comfort and compliance and potential cost savings.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Diabetic foot ulcers with devitalised tissue which are amenable to heal without any amputation
- •Subjects with Type II Diabetes mellitus
- •Subjects without any other contributory comorbidities.
排除标准
- •Morbidly ill patients in ICU
- •Psychiatric patients
- •Bad diabetic ulcer wounds which may progress to amputation
- •Patients with a known allergy or hypersensitivity to any of the constituents of the product
- •Immunocompromised Status.
结局指标
主要结局
Faster granulation tissue formation and Faster wound healing
时间窗: Day 3, 7 and 14
次要结局
- Reduced infection rates, decreased inflammation, enhanced moisture management(Day 3, 7 and 14)
研究者
Dr Aravind K
Saveetha Medical College and Hospital