CTRI/2025/01/079002尚未招募2/3 期
Comparative efficacy of topical insulin, topical phenytoin and standard wound care for treatment of trophic ulcers in patients with leprosy: A Hospital Based Randomized Controlled Trial
Dr. Kaushiki Suman1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年1月31日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Clinical response as indicated by percentage of ulcer area reduction between the three treatment groups after 8 weeks.
研究概览
简要总结
To compare the efficacy of topical insulin, topical phenytoin and standard wound care for the treatment of trophic ulcers in patients with leprosy over a 8 week period of follow up.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age group of 18 to 75 years.
- •Wound area size less than 50 square centimeters.
- •Patients with well controlled diabetes.
排除标准
- •Patients not consenting to the study.
- •Patients with malignant ulcers.
- •Patients with gross cellulitis.
- •Patient with underlying osteomyelitis.
- •Patients with lepra reactions.
- •Pregnant and lactating women.
结局指标
主要结局
Clinical response as indicated by percentage of ulcer area reduction between the three treatment groups after 8 weeks.
时间窗: From baseline to the end of follow up at 8 weeks.
次要结局
- Clinical response as indicated by percentage of ulcers achieving complete healing at the end of 8 weeks in each treatment group.(From baseline to the end of follow up at 8 weeks.)
- Clinical response as indicated by rate of healing of ulcer in each treatment group.(From baseline to the end of follow up at 8 weeks.)
- Assessing the Dermatology Life Quality Index (DLQI) before, during and after completion of 8 weeks.(From baseline to the end of follow up at 8 weeks.)
- Assessing the Physician Global Assessment Score (PGA) before and after completion of 8 weeks.(From baseline to the end of follow up at 8 weeks.)
- Assessing the Incidence of various side effects with Topical Insulin therapy, Topical Phenytoin therapy and Standard Wound Care therapy.(From baseline to the end of follow up at 8 weeks.)
- Assessing the Strength of Association of identified risk factors to wound healing.(From baseline to the end of follow up at 8 weeks.)
研究者
Dr Kaushiki Suman
AIIMS Gorakhpur
研究点 (1)
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