CTRI/2013/07/003838已完成1 期
An Interventional, Placebo-controlled, Randomized, Double blinded, Dose comparison, Phase I/II Study to determine the safety and efficacy of a new gel formulation of Esmolol Hydrochloride (GALNOBAX®) for the treatment of Diabetic Foot Ulcer (DFU) - NI
ovalead Pharma Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients having single or up to two ulcers, minimum 4.0 cm apart, below knee ulcer of at least 4 weeks and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
- •Ulcer should be clinically non-infected as determined by clinical examination and complete hemogram
- •Ulcer area (length x width) measurement between 1.5 square centimeter and 10 square centimeter, inclusive and post debridement ulcer area less than or equal to 12 square centimeter
- •Full-thickness ulcer of Grade 1 or Grade 2 as per Wagnerâ??s classification system
排除标准
- •Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
- •Patients with target limb cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
研究者
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