Local Application of Ozone Gas for Infected Ulcers

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448511
• Other study ID #: Ozone 1
• Status: Completed
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 14, 2015
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Wound Infection

Intervention

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.

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

Locations

Country	Name	City	State
India	St John's Medical College Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
St. John's Research Institute

Country where clinical trial is conducted

India, 

References & Publications (4)

Bocci VA. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res. 2006 May;37(4):425-35. Review. — View Citation

Martínez-Sánchez G, Al-Dalain SM, Menéndez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernández-Montequín JI, León OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. Epub 2005 Sep 29. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	wound closure rate	75 days	No

External Links

•   Ozone in Medicine: Overview and future direction
•   The Story of Ozone