Hyperbaric Oxygen Therapy Combined With Polarized Light Therapy Effect on Neuropathic Foot Ulcer Regarding Transcutaneous Oxygen Saturation (TcpO2) and Healing Rate ( A Randomized Control Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ulcer volume using Saline injection method
研究概览
简要总结
Neuropathic ulcers develop due to nerve damage (neuropathy), commonly seen in conditions like diabetes, leading to loss of sensation, repetitive trauma, and poor wound healing. These ulcers typically occur on weight-bearing areas, hyperbaric oxygen and polarized light therapies may have a synergistic effect, improving oxygenation, cellular activity, and overall healing outcomes in neuropathic ulcers, particularly in diabetic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients had cardiac ejection fraction (CEF) 50%
- •blood pressure (BP) 150/90mmHg.
- •Chest X-ray was reported normal
- •all patients were clinically evaluated by a specialized ear, nose, and throat (ENT) physician to ensure suitability for the hyperbaric chamber.
排除标准
- •chronic obstructive pulmonary disease, malignancy
- •cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
- •chronic peripheral arterial disease.
研究组 & 干预措施
control
topical medication
干预措施: traditional treatment (Other)
study group
patients will evaluated to be fit for HBO therapy to ensure cardiac ejection fraction over 50% and chest CT to ensure chest free from any pathology
干预措施: Hyperbaric oxygen therapy combined with polarized light therapy (Other)
结局指标
主要结局
Ulcer volume using Saline injection method
时间窗: 4 weeks
次要结局
- Tcpo2 at ulcer edge using Pulse Oximeter(4 weeks)
- Emg pre and at end (Sensory NCS (Sural nerve)(4 weeks)
研究者
Hanan Hosny M Battesha
associate professor
Al-Zaytoonah University of Jordan