Local Application of Ozone Gas for Infected Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Ulcer Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ozone

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

Group Type EXPERIMENTAL

Ozone

Intervention Type 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.

Conventional treatment

Intervention Type OTHER

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

Placebo

This group received sham treatment in addition to conventional treatment

Group Type SHAM_COMPARATOR

Placebo

Intervention Type 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.

Conventional treatment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Conventional treatment

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

Intervention Type OTHER

Other Intervention Names

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Ozone gas sham comparator

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No