EUCTR2008-008291-14-GB进行中（未招募）1 期
Study of treatments in Pyoderma Gangrenosum patients - STOP GAP
ottingham University Hospitals NHS Trust0 个研究点目标入组 121 人开始时间: 2009年5月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
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
- •PG as diagnosed by the recruiting dermatologist. [An ulcerative lesion may have mixed aetiology, but provided the investigator has confidence that a clinical diagnosis of PG is appropriate then they are eligible. Other contributing factors and atypical features will be captured in the case report form].
- •Age over 18 years.
- •Able to provide written, informed consent.
- •Presence of a measurable ulceration (e.g not pustular pyoderma gangrenosum)
- •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
- •Pregnant, lactating or at risk of pregnancy.
- •Granulomatous PG – this condition is very rare and may respond differently to treatment.
- •Hypersensitivity to study medication
- •Concomitant ciclosporin, prednisolone or IVIG therapy in the previous month.
- •Biopsy not consistent with PG.
- •Biopsies will be used to exclude alternative aetiologies (e.g. malignancy, granulomatous PG, arteritis) rather than to confirm the diagnosis of PG, since histology is supportive rather than pathognomic. Ideally, the biopsy will be a 1.5cm rectangular biopsy taken through the edge of the ulcer and left to granulate and heal by secondary intention. Alternatively, 2 separate punch biopsies done at the edge of the ulcer and at the extending margin may be used. It is not normal practice to await histological confirmation before initiating therapy, so patients will be randomised prior to receiving histological results. If the histology indicates an alternative aetiology, the participant will be excluded at that time.
- •Clinically significant renal impairment, such that you would not normally treat the patient with either prednisolone or ciclosporin
- •Any pre-treatment investigations, the results of which would prompt you not to use prednisolone or ciclosporin
- •A diagnosis of malignancy or pre-malignant disease where prednisolone or ciclosporin might interfere with ongoing therapy or might cause harm
- •The patient has a concurrent medical condition that means that you would not normally treat the patient with either prednisolone or ciclosporin (e.g a degree of hypertension that would lead to not using either of the study drugs, advanced heart failure, poorly controlled diabetes, history of peptic ulcer, malignancy in previous years)
- •Already participating in another clinical trial.
研究者
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