IRCT201102204272N2已完成2 期
Phase II controlled clinical trial to evaluate safety and efficacy of Angipars in patients with diabetic foot ulcer in Syria
Pars Roos Biotechnology Co.0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years; Presence of diabetic foot ulcer for a minimum duration of 1 months due to various reasons such as peripheral neuropathy, foot deformity, trauma or inappropriate shoes' limitation of activity, uncontrolled blood glucose, long term diabetes mellitus, etc.;
- •Wound size more than 2 cm squared;
- •Age more than 18 and less than 75;
- •Exclusion criteria:
- •Presence of acute infection of the ulcer with or without pus drainage or erythema of the ulcer margins of 3 cm width; Presence of wound with visible bone or signs suggestive of acute osteomyelitis; Presence of severe cardiac condition with functional class of 3 or higher or under treatment; Presence of signs and symptoms suggestive of severe and chronic ischemia with absence of peripheral pulses (absence of peripheral pulse alone is not an exclusion criteria); Any concurrent diseases or conditions which delay wound healing (cancer, vasculitis, ect.); Drug and alcohol abuse; Presence of chronic renal failure on hemodialysis or peritoneal dialysis; Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy; Any known drug hypersensitivity; Inability or refusal to sign the informed consent; Receiving any investigational drug within 30 days prior to screening; Pregnancy or intention of becoming pregnant during the study period.
排除标准
- 未提供
研究者
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