Local Application of Ozone Gas for Infected Ulcers
Primary Purpose
Ulcer, Wound Infection
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ozone
Placebo
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer focused on measuring ozone gas, ulcer, infected ulcer
Eligibility Criteria
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
Sites / Locations
- St John's Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Ozone
Placebo
Arm Description
this group received local application of ozone gas in addition to conventional treatment.
This group received sham treatment in addition to conventional treatment
Outcomes
Primary Outcome Measures
wound healing
wound closure rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02448511
First Posted
May 12, 2015
Last Updated
May 14, 2015
Sponsor
St. John's Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02448511
Brief Title
Local Application of Ozone Gas for Infected Ulcers
Official Title
Local Application of Ozone Gas for Infected Ulcers: A Double Blinded Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. John's Research Institute
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Wound Infection
Keywords
ozone gas, ulcer, infected ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozone
Arm Type
Experimental
Arm Description
this group received local application of ozone gas in addition to conventional treatment.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
This group received sham treatment in addition to conventional treatment
Intervention Type
Other
Intervention Name(s)
Ozone
Other Intervention Name(s)
Ozone gas
Intervention Description
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
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
sham comparator
Intervention Description
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
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups
Primary Outcome Measure Information:
Title
wound healing
Description
wound closure rate
Time Frame
75 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony P Rozario, DNS,FRCS
Organizational Affiliation
St Johns Medical College Hospital, Bangalore, India
Official's Role
Study Director
Facility Information:
Facility Name
St John's Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
16624639
Citation
Bocci VA. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res. 2006 May;37(4):425-35. doi: 10.1016/j.arcmed.2005.08.006.
Results Reference
background
PubMed Identifier
25089169
Citation
Zhang J, Guan M, Xie C, Luo X, Zhang Q, Xue Y. Increased growth factors play a role in wound healing promoted by noninvasive oxygen-ozone therapy in diabetic patients with foot ulcers. Oxid Med Cell Longev. 2014;2014:273475. doi: 10.1155/2014/273475. Epub 2014 Jun 24.
Results Reference
result
PubMed Identifier
21751891
Citation
Wainstein J, Feldbrin Z, Boaz M, Harman-Boehm I. Efficacy of ozone-oxygen therapy for the treatment of diabetic foot ulcers. Diabetes Technol Ther. 2011 Dec;13(12):1255-60. doi: 10.1089/dia.2011.0018. Epub 2011 Jul 13.
Results Reference
result
PubMed Identifier
16198334
Citation
Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. doi: 10.1016/j.ejphar.2005.08.020. Epub 2005 Sep 29.
Results Reference
result
Links:
URL
http://www.o3center.org/Articles/TheStoryofOzone.html
Description
The Story of Ozone
URL
http://www.triroc.com/sunnen/topics/ozonemed.htm
Description
Ozone in Medicine: Overview and future direction
Learn more about this trial
Local Application of Ozone Gas for Infected Ulcers
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