EUCTR2006-000487-92-IE进行中（未招募）不适用
A Phase II, Randomised, Double Blind, Placebo Controlled Study examining the suitability of Phenytoin Sodium Topical Gel in the treatement of Venous Ulcers
Royal College of Surgeon's Ireland0 个研究点开始时间: 2006年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •Eligible subjects MUST comply with the following criteria:
- •1. Subject must have a venous ulcer in the lower leg with a surface area of at least 5cm2 (as indicated by clinical signs and symptoms of venous ulceration, such as hyperpigmentation of surrounding skin, varicosities, and lipodermatosclerosis).
- •2. Subject must be more than 18 years old.
- •3. Absence of significant arterial insufficiency in the affected limb (indicated by an ankle-brachial index of >0.70).
- •4. Evidence of venous insufficiency on Doppler.
- •5. Wound must be free of eschar and obvious necrotic tissue.
- •6. Wounds must be free from cellulites and exudation indicative of heavy bacterial contamination (treatment of bacterial infections with antibiotics prior to commencement is permitted).
- •7.Provision of a written informed consent prior to enrolment.
- •8.Agree to avoid pregnancy and not to nurse a child throughout the study (females of child-bearing potential)
- •9.All females of child bearing potential must have a negative pregnancy test at the Screening Visit and agree to practice a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilised
- •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
- •Eligible subjects MUST NOT:
- •1. Have clinical signs of cellulites.
- •2. Have clinical signs or history of vasculitis.
- •3. Have clinical signs or history of collagen vascular diseases.
- •4. Be pregnant or lactating.
- •5. Have a history of rheumatoid arthritis.
- •6. Have sickle cell anaemia.
- •7. Have uncontrolled diabetes mellitus (subjects with well-controlled diabetes mellitus will be included).
- •8. Have other clinically significant medical conditions that would impair wound healing, inclusive of renal, hepatic, haematological, neurological, or immunological disease or poor nutritional status (albumin <30g/l).
- •9. Be receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within one month prior to entry into the study.
- •10. Be receiving phenytoin or nifedipine for the treatment of other conditions.
- •11. Be receiving drugs that might affect ulcer healing, such as stanazol, paroven, or oxypentifylline.
- •12. Be currently included in other clinical trials involving investigational medicinal product.
- •13. Be included in a clinical trial within the previous 4 weeks.
- •14. Have a history of allergic or hypersensitivity reaction to phenytoin or other constituents of the gel.
- •15. Have ulcers with exposed bone or tendons.
研究者
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