临床试验/NCT04244201

NCT04244201已完成不适用

Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds

Vaporox0 个研究点目标入组 31 人开始时间: 2005年6月6日最近更新: 2020年1月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Vaporox
入组人数: 31
主要终点: Wound healing rate at 12 weeks

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

详细描述

The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
•University of Texas Health Science Center classification: Grade 0, 1, and 2

排除标准

•Ulcers above the medial and lateral malleoli
•Etiology of cancer/neoplastic
•Etiology of collagen vascular disease
•Etiology of gangrene
•Etiology of osteomyelitis (Grade 3)
•Etiology of thermal burns
•Etiology of radiation injury
•Pregnancy
•Acute skin conditions
•Inadequate perfusion to support treatment
•Wounds where the end cannot be probed
•Wounds covered with petroleum based dressing
•Non-compliant patients

结局指标

主要结局

Wound healing rate at 12 weeks

时间窗: 12 weeks

The percent of subjects that achieved wound healing at 12 weeks

次要结局

Time to wound healing(up to 12 weeks)

研究者

发起方

Vaporox

申办方类型

Industry

责任方

Sponsor

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