Local Application of Ozone Gas for Infected Ulcers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ulcer, Wound Infection

Intervention / Treatment
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* Other: Ozone
* Device: Placebo
* Other: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone<br>this group received local application of ozone gas in addition to conventional treatment. | Other: Ozone<br>* ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.<br>* Other names: Ozone gas;Other: Conventional treatment<br>* Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups<br>|
| Sham Comparator: Placebo<br>This group received sham treatment in addition to conventional treatment | Device: Placebo<br>* 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.<br>* Other names: sham comparator;Other: Conventional treatment<br>* Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | wound closure rate | 75 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozone gas, ulcer, infected ulcer