Healing of Ischemic Leg Ulcers: A Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The percentage change of ulcer area 8 weeks after initiation of therapy.
研究概览
简要总结
The main objective of this trial is to study the healing effect of an oral drug (isoniazid) in patients with ischemic (arterial) leg ulcers defined by a systolic toe pressure <40 mm Hg.
详细描述
Treatment of arterial ulcers is problematic. Previous pharmaceutical interventions with for example prostaglandins have produced only limited beneficial effects but have been associated with frequent adverse effects. Positive effects of isoniazid have been observed in a preclinical model of ischemic wound healing (Weinreich et al. Surgery 2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic leg ulcers unsuitable for vascular surgical intervention
- •Systolic toe pressure < 40 mm Hg
- •Ulcer duration > 3 months
- •Ulcer area: 1-20 cm2
- •Written informed consent
排除标准
- •B-Hb < 6 mmol/l
- •Aspartate transaminase > 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, benzodiazepines (diazepam, triazolam), stavudine and/or valproat
- •Alcohol abuse
- •Hereditary galactose intolerance
- •Hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, povidone, talcum, lactose and starch)
- •Cellulitis or deep infection (osteomyelitis and/or tendonitis) related to the ulcer
- •Participation in clinical trials within the last 7 days
- •Pregnancy or breastfeeding
- •Women of child bearing potential who decline to use contraception
研究组 & 干预措施
A
Placebo tablets.
干预措施: Placebo (Drug)
B
干预措施: Isoniazid 300 milligram (Drug)
结局指标
主要结局
The percentage change of ulcer area 8 weeks after initiation of therapy.
时间窗: 8 weeks
The wound area is measured at week 0 (A0) and at 8 weeks (A8). From these measurements, the percentage (%) change of the wound area in relation to the start time (week 0) is determined from the following formula: (A0-A8)/A0\*100.
次要结局
- Pain is evaluated by visual analogue scale (VAS).(8 weeks)
- Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)(8 weeks)
研究者
Magnus Agren
Professor
Pharma 2100