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临床试验/CTRI/2025/09/094750
CTRI/2025/09/094750尚未招募3 期

Randomised controlled trial on effect of Zinc Oxide Nanoparticles on chronic wounds

IOE Grant IMS BHU1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
144
试验地点
1
主要终点
To measure the reduction in wound size

研究概览

简要总结

This study is a randomised controlled trial single blinded to be done on patients of chronic wounds for upto a period of three years or till sample size is achieved whichever is earlier. In this study zinc oxide nanoparticles will be applied on chronic wounds along with placebo in other group and the reduction in wound size would be the primary outcome. Secondary outcome would be the change in levels of collagen in wound tissue.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • All patients of Chronic wounds (Diabetic foot ulcers, Venous ulcers, Pressure ulcers).

排除标准

  • Patient not giving consent Patient already on other modalities of treatment other than simple dressings (NPWT, Bacteriophage therapy, Electrical stimulations, etc.) Radiation therapy Chemotherapy Hemoglobin less than 10 mg per dL Pregnant and Lactating females Patients with lymphedema and lymphangitis.

结局指标

主要结局

To measure the reduction in wound size

时间窗: 10 weeks

次要结局

  • To estimate the change in level of collagen(10 weeks)

研究者

发起方
IOE Grant IMS BHU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vipul Kumar Srivastava

Institute of Medical Sciences BHU

研究点 (1)

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