ACTRN12616000520437招募中1 期
A double blind (pilot) trial of the application of 0.2% glyceryl trinitrate ointment for the healing of chronic venous leg ulcers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 45 Years 至 o limit（—）
- 性别
- All
入选标准
- •transdermal oxygen sensors will not be used. Clinical judgement will be used.
- •This investigation seeks to recruit consenting patients with venous leg ulceration from the internal medicine wards of the Prince Charles Hospital (TPCH). Venous ulceration will be confirmed by clinical judgement and patient notes and/or confirmation by medical and/or podiatry team. This is to rule out ulceration by other aetiologies (i.e. arterial, pressure, diabetic) which have been shown in earlier studies to not benefit from GTN application (data not published).
- •Patients recruited into this study will be informed that their participation in this trial is entirely voluntary and no financial payment will be given. If patients decide to not take part in this study, there will be no prejudice against their future care and are free to withdraw at any time. Consenting patients will then be randomly allocated to one of two groups (placebo versus GTN treatment).
排除标准
- •Patients must have venous ulceration. Additionally, patients with malignant ulcers or have other forms of malignancy will be excluded from the study together with any patient who has active autoimmune disease or have had organ transplantation. Patients with acute exacerbation of cardiac disease may be excluded from treatment with GTN as the product may lower blood pressure. Those with ongoing / active cardiac disease will be included.
研究者
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