Local Application of Ozone Gas for Infected Ulcers

Not Applicable

Completed

• Conditions: Wound Infection; Ulcer
• Interventions: Other: Ozone; Device: Placebo; Other: Conventional treatment

• Registration Number: NCT02448511
• Lead Sponsor: St. John's Research Institute

Brief 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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2015-05
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-14
• Last Update Submitted: 2015-05-14
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone	Ozone	this group received local application of ozone gas in addition to conventional treatment.
Ozone	Conventional treatment	this group received local application of ozone gas in addition to conventional treatment.
Placebo	Placebo	This group received sham treatment in addition to conventional treatment
Placebo	Conventional treatment	This group received sham treatment in addition to conventional treatment

Primary Outcome Measures

Name	Time	Method
wound healing	75 days	wound closure rate

Trial Locations

Locations (1)

St John's Medical College Hospital; 🇮🇳 Bangalore, Karnataka, India