Et velkendt lægemiddels helende effekt på iskæmiske sår: et randomiseret dobbelt-blindt placebokontrolleret pilotforsøg - SONIA

Pharma 2100 ApS0 个研究点开始时间: 2007年7月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Age > 18 years
•- Patients with ischemic leg ulcers unsutiable for vascular surgical intervention
•- Systolic toe pressure < 40 mm Hg
•- Ulcer duration > 3 months
•- Ulcer area: 1-20 cm2
•- Written informed consent.
•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

•- Anaemia (Hb < 6 mmol/l).
•- ASAT > 50 U/l
•- Diabetes mellitus > 10 % HbA1c
•- Usage of more than 10 mg prednisolone daily within the last 30 days
•- Usage of cytotoxic agents with the last 3 months
•- Usage of rifampicin, phenytoin, carbamazepin, theophylline, benzodiazepiner (diazepam, triazolam), stavudin and/or valproat
•- Alcohol abuse
•- Hereditary galactose intolerance
•- Hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, polyvidone, talcum, lactose and starch)
•- Cellulitis or deep infection (osteomyelitis and/or tendonitis) related to the ulcer
•- Gangrene
•- Participation in clinical trials within the last 7 days
•- Pregnancy or breastfeeding
•- Women of child bearing potential who decline to use contraception

发起方