RPCEC00000060已完成3 期
Intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot and risk of major amputation.
Center for Genetic Engineering and Biothecnology (CIGB), Havana.0 个研究点目标入组 147 人开始时间: 2009年2月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1.Diagnosis of diabetic foot ulcer, Wagner's grade 3 or 4. 2.Age = 18 years. 3.Patient’s signed informed consent.
排除标准
- •1.Ulcer area < 1 cm2. 2.Haemoglobin <100 g/l. 3.Uncompensated chronic diseases (ischemic heart illness, diabetic coma or ketoacidosis, renal failure). 4.History or suspect of malignancies (physical examination, rectal tact, breast examination, abdominal ultrasound, thorax radiography and blood chemistry). 5.Use of drugs that can impair evaluation: immunosuppressors or corticosteroids. 6.Psychiatric or neurological diseases that could impair proper reasoning for consent. 7.Pregnancy or nursing.
研究者
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