NCT01954901终止不适用
Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
David Grant U.S. Air Force Medical Center2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of wounds healed
研究概览
简要总结
The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.
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
- Double (Participant, Investigator)
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
- •Age equal to or greater than
- •Type 1 or 2 diabetes mellitus.
- •Wagner Grade 2 wound for at least 4 weeks. A diagnosis of a Wagner Grade 2 wound necessitates a persistent wound of 4 weeks (5).
- •DoD Beneficiary.
排除标准
- •Impending/urgent amputation due to ongoing or exacerbated infection.
- •Severe depression.
- •Claustrophobia.
- •Seizure disorder.
- •Uncontrolled asthma/severe COPD with pCO2 > 45 mmHg on arterial blood gas.
- •Grade 4 congestive heart failure.
- •Unstable angina.
- •Chronic/acute otitis media/sinusitis.
- •Major tympanic membrane trauma.
- •Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
- •Candidates for vascular surgery/angioplasty/stenting or patients with major large vessel disease. These patients could have peripheral vascular disease of such severity that hyperbaric treatment would not improve their condition.
- •Vascular surgery/angioplasty within the last 3 months. This exclusion controls for improvements to a patients vasculature and perfusion that occur within 1-2 months after vascular surgery/angioplasty. This will ensure that any perfusion changes to the patient's diabetic wound ulcer area recorded during the study are a result of hyperbaric therapy instead of recent vascular procedures.
- •Women who are breast feeding or of childbearing potential.
- •Dementia or mental disability rendering the potential subject incapable of following instructions or consenting to treatment.
结局指标
主要结局
Number of wounds healed
时间窗: 14 months
Number of major and minor amputations
时间窗: Three Years after initiation of study
Changes in wound size - wounds measured by length, width and depth
时间窗: 14 months
次要结局
- Recurrence of ulceration(14 months)
- Peri-wound TCOM values(14 months)
研究者
研究点 (2)
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