Ulcer, Wound Infection
Conditions
Keywords
ozone gas, ulcer, infected ulcer
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.
Interventions
OTHEROzone
ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.
DEVICEPlacebo
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.
OTHERConventional treatment
Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups
Sponsors
St. John's Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing | 75 days | wound closure rate |
Countries
India
Outcome results
None listed