UlcerNCT02448511
Local Application of Ozone Gas for Infected Ulcers
A study testing Ozone and Conventional treatment in people with Ulcer and Wound Infection, run by St. John's Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Wound Infection
- What is being tested?
- Ozone and Conventional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- infected ulcer size of atleast 10 cm.
- patient willing to participate in the study and for follow up.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Application of Ozone Gas for Infected Ulcers: A Double Blinded Randomized Control Trial
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.
Read the 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.
- Conditions
- Ulcer, Wound Infection
- Being tested
- Ozone, Placebo, Conventional treatment
- Keywords
- ozone gas, ulcer, infected ulcer
- Medical subject headings
- Ulcer, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneOther
Also called Ozone gas
ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.
PlaceboDevice
Also called sham comparator
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 treatmentOther
Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups
| Study group | Role | What they receive |
|---|---|---|
| Ozone | Experimental | this group received local application of ozone gas in addition to conventional treatment. Receives: Other: Ozone; Other: Conventional treatment |
| Placebo | Sham comparator | This group received sham treatment in addition to conventional treatment Receives: Device: Placebo; Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
wound closure rate
Measured: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony P Rozario, DNS,FRCS, Study director, St Johns Medical College Hospital, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448511
- Sponsor's protocol ID
- Ozone 1
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16624639Zhang 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.
PubMed 25089169Wainstein 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.
PubMed 21751891Martinez-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.
PubMed 16198334
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Application of Ozone Gas for Infected Ulcers: A Double Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02448511
- Acronym / sponsor ID
- Ozone 1
- Conditions
- Ulcer, Wound Infection
- Keywords
- ozone gas, ulcer, infected ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone | Experimental | Other: Ozone, Other: Conventional treatmentthis group received local application of ozone gas in addition to conventional treatment. |
| Placebo | Sham comparator | Device: Placebo, Other: Conventional treatmentThis group received sham treatment in addition to conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- infected ulcer size of atleast 10 cm.
- patient willing to participate in the study and for follow up.
Key exclusion criteria (7 listed)
- patient unwilling for participation and follow up.
- chronic kidney disease,
- peripheral occlusive vascular disease,
- venous ulcers,
- pressure sores,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzoneAlso: Ozone gasozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition. | Other | Ozone |
| PlaceboAlso: sham comparatora 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. | Device | Placebo |
| Conventional treatmentConventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups | Other | Ozone, Placebo |
Primary outcome
wound healing
Time frame: 75 days
wound closure rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Background: PubMed 16624639Bocci 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 publication: PubMed 25089169Zhang 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 publication: PubMed 21751891Wainstein 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 publication: PubMed 16198334Martinez-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.
- The Story of OzoneLink provided by the sponsor.
- Ozone in Medicine: Overview and future directionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Rozario, DNS,FRCS study director
St Johns Medical College Hospital, Bangalore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone and Conventional treatment in people with Ulcer and Wound Infection, run by St. John's Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 75 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448511, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.