Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- wound healing
研究概览
简要总结
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
详细描述
OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 20 years of age
- •a history of diabetes and a diagnosis of diabetic foot
- •a wound classification of Grade 3 or below
- •clear conscious and willing to participate in this study
- •a signed consent form
排除标准
- •less than 20 years of age, unwilling to participate
结局指标
主要结局
wound healing
时间窗: 4 weeks
The Wagner Ulcer Grade Classification System for wound physiological index
次要结局
- bacteriological wound cultures(4 weeks)
- survival rate of tissue in the affected limb(4 weeks)
- inflammation index(4 weeks)
- amputation rate(4 weeks)
- glycemic control(4 weeks)
研究者
Chen-Yu Chen
Registered Nurse
Chang Gung Memorial Hospital