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Completed

NCT Number: NCT02448511

Local Application of Ozone Gas for Infected Ulcers

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St John's Medical College Hospital

Bangalore, Karnataka, 560034, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ozone

Other

ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.

Other names: Ozone gas

PLACEBO

Device

a similar looking device was applied to the affected part for a period of one hour each day under sub atmospheric condition. the device did not produce any gas.

Other names: sham comparator

conventional treatment

Other

Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups

Primary outcomes

  1. wound healing

    Time frame: 75 days

    wound closure rate

Sponsors and collaborators

Lead sponsor

St. John's Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 19, 2015
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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