Local Application of Ozone Gas for Infected Ulcers

St. John's Research Institute

Status: Completed

Conditions: Ulcer; Wound Infection

Treatments: Other: Conventional treatment; Device: Placebo; Other: Ozone

Study type: Interventional

Funder types: Other

Identifiers

NCT02448511

Ozone 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Ozone

Experimental group

Description:

this group received local application of ozone gas in addition to conventional treatment.

Treatment:

Other: Ozone

Other: Conventional treatment

Placebo

Sham Comparator group

Description:

This group received sham treatment in addition to conventional treatment

Treatment:

Device: Placebo

Other: Conventional treatment