NCT00953186已完成4 期
Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
Mrs. Thelma Zoegas Foundation2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2002年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Ulcer healing
研究概览
简要总结
The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot 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
- 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
- •diabetes mellitus,
- •foot ulcer with duration > 3 months,
- •treatment at Diabetes foot clinic for > 2 months,
- •vascular surgical intervention had not been recommended for the affected lower limb.
排除标准
- •severe obstructive pulmonary disease,
- •malignancy and untreated thyrotoxicosis),
- •current drug or alcohol misuse,
- •vascular surgery in the lower limbs within the last two months,
- •participation in another study or suspected poor compliance.
结局指标
主要结局
Ulcer healing
时间窗: 3, 6, 9, 12, 18, 24 months
次要结局
- Amputationrate(6, 12, 24 months)
- time to ulcer healing(24 months)
- QoL(3, 6, 12, 18, 24 months)
研究者
研究点 (2)
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