EUCTR2004-004787-74-GB进行中（未招募）1 期
A double blind, prospective, randomised, controlled clinical trial to evaluate the effect of topical phenytoin, on healing, in diabetic foot ulcers. - none
Royal Group of Hospitals Trust0 个研究点目标入组 144 人开始时间: 2005年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age: At least 18 years of age.
- •2.Gender: Males and females
- •3.Patients presenting with Type 1 or Type 2 diabetes
- •4.Foot ulcer / wound of at least 4 weeks duration
- •5.Stable vascular status –
- •Ankle Brachial Pressure Index > 0.4
- •No acute ischaemia / rest pain
- •No necrosis or gangrene
- •Post vascular reconstruction
- •6. Evidence of neuropathy - VPT’s greater than 25 volts
- •Diminished sensation to 10g monofilament
- •Reduced blunt / sharp discrimination
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acute ischaemia / rest pain/ necrosis or gangrene (of the wound) - ABPI < 0.4
- •2.Worsening claudication
- •3.Worsening clinical infection, cellulitis, amputation
- •4.Patient unwilling to participate in study
- •5.Patients who have significant hepatic or end stage renal disease
- •6.Patients who have malignant disease
- •7.Pregnancy
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