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Local Application of Ozone Gas for Infected Ulcers

Sponsor
St. John's Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02448511
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
11
Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ozone
  • Device: Placebo
  • Other: Conventional treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Local Application of Ozone Gas for Infected Ulcers: A Double Blinded Randomized Control Trial
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ozone

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

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.
Other Names:
  • Ozone gas

    • Other: Conventional treatment
    Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups
    Sham Comparator: Placebo

    This group received sham treatment in addition to conventional treatment

    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 Names:
  • sham comparator

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

    Outcome Measures

    Primary Outcome Measures

    1. wound healing [75 days]

      wound closure rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St John's Medical College Hospital Bangalore Karnataka India 560034

    Sponsors and Collaborators

    • St. John's Research Institute

    Investigators

    • Study Director: Anthony P Rozario, DNS,FRCS, St Johns Medical College Hospital, Bangalore, India

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    St. John's Research Institute
    ClinicalTrials.gov Identifier:
    NCT02448511
    Other Study ID Numbers:
    • Ozone 1
    First Posted:
    May 19, 2015
    Last Update Posted:
    May 19, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by St. John's Research Institute
    ozone gas
    ulcer
    infected ulcer
    Additional relevant MeSH terms:
    Wound Infection
    Ulcer

    Study Results

    No Results Posted as of May 19, 2015