NCT02448511

Local Application of Ozone Gas for Infected Ulcers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ulcer
• Wound Infection

Interventions

Type	Name	Description
OTHER	Ozone	ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.
DEVICE	Placebo	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	Conventional treatment	Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2015-05-19
• Last updated: 2015-05-19

Locations

1 site across 1 country: India