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临床试验/NCT02448511
NCT02448511已完成不适用

Local Application of Ozone Gas for Infected Ulcers: A Double Blinded Randomized Control Trial

St. John's Research Institute1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
wound healing

研究概览

简要总结

This study evaluates the efficacy of local application of ozone gas in healing of infected ulcers. Half the participants received conventional treatment with placebo generator and the other half received conventional treatment with ozone generator.

详细描述

Ozone gas has been used since World war I and is known for its wound healing properties by way of being a powerful oxidant that stimulates the antioxidant system, immunomodulation, microbicidal and perhaps other unknown mechanisms. It has largely been regarded as a complementary therapy form but with elucidation of it's biological actions and availability of reliable ozone generators it may form a novel treatment option for a range of medical conditions with ample literature available on wound healing. In this study it was used as an adjunct to conventional treatment i.e surgical procedures, antibiotics and wound care. It was locally applied as a gas though there are various other routes of administration such as major and minor autohematotherapy, intramuscular and intraarticular injections, rectal and vaginal insufflation.

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

  • •infected ulcer size of atleast 10 cm.
  • •patient willing to participate in the study and for follow up.

排除标准

  • •patient unwilling for participation and follow up.
  • •chronic kidney disease,
  • •peripheral occlusive vascular disease,
  • •venous ulcers,
  • •pressure sores,
  • •use of immuno suppressant drugs,
  • •immunosuppressed state

研究组 & 干预措施

Ozone

Experimental

this group received local application of ozone gas in addition to conventional treatment.

干预措施: Conventional treatment (Other)

Placebo

Sham Comparator

This group received sham treatment in addition to conventional treatment

干预措施: Placebo (Device)

Placebo

Sham Comparator

This group received sham treatment in addition to conventional treatment

干预措施: Conventional treatment (Other)

Ozone

Experimental

this group received local application of ozone gas in addition to conventional treatment.

干预措施: Ozone (Other)

结局指标

主要结局

wound healing

时间窗: 75 days

wound closure rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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