Clinical trial NCT02448511: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer
Wound Infection
Keywords: ozone gas
ulcer
infected ulcer
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: wound healing
timeFrame: 75 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St John's Medical College Hospital
state: Karnataka
Study officials:
affiliation: St Johns Medical College Hospital, Bangalore, India
name: Anthony P Rozario, DNS,FRCS
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.