Double- blind Randomized controlled trial comparing the efficacy of topical Ozone-Oxygen mixture therapy with sham procedure in the treatment of patients with chronic wounds..

Double-blind Randomized control trial of Ozone therapy for the treatment of chronic wounds

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2022/004

Enrollment

Unknown

Registered

2022-03-21

Start date

2022-03-23

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic wounds

Interventions

The study setting includes the professorial surgical wards and surgical clinics of Teaching Hospital Anuradhapura. Participants will be patients aged 18 or over with chronic wounds, who have not recei

Eligibility

Inclusion criteria

Inclusion criteria: Males and females who are 18 years or older with chronic wounds (wounds that fail to proceed through the normal phases of wound healing in an orderly and timely manner).

Exclusion criteria

Exclusion criteria: • Patients with known contraindication to ozone therapy • Any patient who had previously been treated with ozone or hyperbaric oxygen therapy, • A history of collagen disease, • Pregnant mothers. • Participants with cognitive impairment (patients with psychotic illnesses, learning disability).

Design outcomes

Primary

Measure	Time frame
1. The wound healing effect at 4,8,12 weeks of treatment is determined by the wound condition, length, width, depth, surface area, ulcer area, healing progression, presence of infection, and the need for debridement. Ulcer area will be calculated from film transparency tracings using grid paper. The criterion of the therapeutic effect includes: Grade 0 – no change or worse than before Grade 1 – wound size reduced less than ½ of the original wound Grade 2 – wound size reduced more than ½, the secretion obviously less than before, there is little necrosis, fresh granulation generated Grade 3 – wound healing, completely epithelialized with dimensions at 0 ×0×0 cm. Proportion of patients in each category will be calculated. [At baseline and at the end of weeks 1, 2, 3, 4, 6, 8, 10, and 12.]	—

Measure

Time frame

1. The wound healing effect at 4,8,12 weeks of treatment is determined by the wound condition, length, width, depth, surface area, ulcer area, healing progression, presence of infection, and the need for debridement. Ulcer area will be calculated from film transparency tracings using grid paper. The criterion of the therapeutic effect includes: Grade 0 – no change or worse than before Grade 1 – wound size reduced less than ½ of the original wound Grade 2 – wound size reduced more than ½, the secretion obviously less than before, there is little necrosis, fresh granulation generated Grade 3 – wound healing, completely epithelialized with dimensions at 0 ×0×0 cm. Proportion of patients in each category will be calculated. [At baseline and at the end of weeks 1, 2, 3, 4, 6, 8, 10, and 12.]

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Secondary

Measure	Time frame
1. Symptomatic improvement will be assessed by a questionnaire. Symptomatic improvement and improvement in quality of life will be assessed by a wound-specific questionnaire, the “wound -QoL -17 questionnaire”, containing17 items. Questions 1-4 involves symptoms due to the wound while others are on the psychological impact and limitation of daily activities. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much). The mean scores will be compared. [At baseline and at the end of weeks 1, 2, 3, 4, 6, 8, 10, and 12.]	—

Measure

Time frame

1. Symptomatic improvement will be assessed by a questionnaire. Symptomatic improvement and improvement in quality of life will be assessed by a wound-specific questionnaire, the “wound -QoL -17 questionnaire”, containing17 items. Questions 1-4 involves symptoms due to the wound while others are on the psychological impact and limitation of daily activities. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much). The mean scores will be compared. [At baseline and at the end of weeks 1, 2, 3, 4, 6, 8, 10, and 12.]

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Countries

Sri Lanka

Contacts

Public ContactDr.Senaka Pilapitiya

Senior Lecturer

senaka.pilapitya@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026