NCT04210609Unknown不适用
Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Vaporox
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Wound closure rate at 20 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
详细描述
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
- •Wound has resisted healing with standard wound care for at least 6 weeks
- •No symptoms of sepsis
- •Able to maintain reasonable nutrition and hydration
- •Able to maintain adequate home care between treatment visits
- •Able to understand and follow basic wound care instructions, or has caregiver who can assist
排除标准
- •Skin wounds cancer/neoplastic etiology
- •Wounds that involve osteomyelitis or tendon involvement
- •Diagnosis of methicillin resistant staph aureus by wound swab
- •Acute skin conditions
- •Surgery within 30 days of study onset
- •Wounds where the end cannot be probed
- •Participation in another clinical trial within 120 days prior to study onset
- •Non-compliant patients
- •Pregnancy
- •Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study
结局指标
主要结局
Wound closure rate at 20 weeks
时间窗: 20 weeks
The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage
次要结局
- Wound closure rate at 12 weeks(12 weeks)
- Time to 50%, 75%, 100% wound closure(Up to 20 weeks)
研究者
研究点 (6)
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