SLCTR/2016/008尚未招募3 期
The efficacy of topical phenytoin ointment on healing venous leg ulcers: a randomized double blind placebo controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- •1. Male and female patients above 18 years with a single lower limb venous ulcer
- •2. Area of ulcer more than 4 cm2 and less than 25cm2
- •3. Duration of the ulcer less than 8 weeks
- •4. Duplex scan evidence of venous insufficiency demonstrated
排除标准
- •1. Patients who have the following comorbidities:
- •a. Occlusive arterial disease – Ankle Brachial Pressure Index (ABPI) below 0.9
- •b. Uncontrolled diabetes mellitus with HbA1c > 8% or > 3 or more fasting blood glucose values in
- •the last 6 months > 250mg/dl
- •c. Chronic kidney disease Stage III and above
- •d. Diagnosed chronic liver disease
- •e. Heart failure NYHA class 3 or 4
- •f. Diagnosed Vasculitis
- •g. Anemia with Hb less than 10g/dL
- •2. Recent (< 6 months) varicose vein surgery, laser ablation or sclerotherapy
- •3. Ulcers with infection/cellulitis/ osteomyelitis
- •4. Current smokers
- •5. Patients with history of allergy to phenytoin
- •6. Patients with epilepsy who are on oral phenytoin
研究者
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