ACTRN12611000505909已完成未知
The effectiveness of hyperbaric oxygen therapy (HBOT) for healing chronic venous leg ulcers: A randomised, double blind, placebo-controlled trial
Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC0 个研究点目标入组 84 人开始时间: 2011年5月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 84
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Persons presenting with a venous leg ulcer that have an Ankle branchial pressure index between 0.8 and 1.2, a TCOM reading that indicates a hypoxic wound responsive to an oxygen challenge, who are not at risk for hyperbaric-related complications and whose ulcer has not responded to standard treatment (i.e., <50% reduction in ulcer area following 4 weeks of treatment.
排除标准
- •1. Persons with cognitive impairment.
- •2. Persons with an Ankle Branchial Pressure Index <0.8 or >1.2.
- •3. Persons with leg ulcers of non-venous aetiology.
- •4. Persons considered to be at specific risk for hyperbaric-related complications, as specified below:
- •-pregnancy
- •-concurrent administration of disulfuram, or antineoplastic agents doxorubicin and cisplatinum.
- •-reactive airway disease (COPD with CO2 retention), radiographic evidence of pulmonary blebs/bullae
- •-untreated pneumothorax or history of spontaneous pneumothorax
- •-previous documented ejection fraction less than 35% or cardiovascular instability
- •-history of seizures - except childhood febrile seizures
- •-unable to follow simple commands, not orientated to person, place, time.
- •-prior chest surgery, middle ear surgery, optic neuritis, fever, congenital , spherocytosis, claustrophobia.
研究者
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