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Efficacy of Ozone Treatment in Patients with Circulatory Disease (in the veins) and Leg Wounds

Evaluation of the Efficacy of Ozone Therapy Applied to the Treatment of Venous Ulcers: Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9586tdy
Enrollment
Unknown
Registered
2022-08-10
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Varicose Ulcer

Interventions

30 adult and / or elderly patient patients with varicose ulcers will be followed up on an outpatient basis (1x / week) for 6 months. Of these, 15 patients will receive standard treatment (ulcer cleani

Sponsors

Fundação Universidade Federal de Sergipe
Lead Sponsor
Fundação Universidade Federal de Sergipe
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age; Both sexes; Confirmed medical diagnosis of venous insufficiency recorded in the patient's medical record and confirmed by USG doppler of the lower limbs; Presence of pedal and tibial pulses after palpation in the lower limbs

Exclusion criteria

Exclusion criteria: Patients with infectious and contagious disease; Chronic use of corticosteroids; Bedridden or wheelchair; Diabetics; Pregnant women; Patients who show signs of allergy to any of the components of the Unna Boot; Infection in the ulcer bed; Low adherence: Irregularities in the frequency of visits to consultations (Missing 3 times without justification) or discontinuity in the use of the products

Design outcomes

Primary

MeasureTime frame
Reduction of ulcer surface area verified by calculating the greatest wound height (length) x greatest width, using a disposable ruler and multiplying the two values in centimeters. The result will show the size of the ulcer in square centimeters. In addition to the ruler, software (image tool 4.2) will be used to verify the lesion area. The initial area will be compared with the final area (after 24 weeks of treatment).

Secondary

MeasureTime frame
Improvement of the appearance of the tissue present in the bed (red, yellow or black). It will be evaluated through the physical examination during the consultation and compared with the photographs during the patient's follow-up time, which color of the tissue prevails in the bed - red, yellow or black. The tissue present in the bed will be compared in greater proportion at the initial time and compared with the final time (after 24 weeks of treatment).;Pain reduction. Pain reduction will be assessed using the Verbal Descriptors Scale: no pain; Light; moderate; strong; severe or worse pain. Initial and final pain assessment (after 24 weeks of treatment) will be compared.;Perilesional area intact or with improvement. It will be evaluated through physical examination during the consultation and compared with the photographs during the follow-up time if there has been a reduction in hyperpigmentation, a reduction in eczema and an improvement in hydration. The initial perilesional area will be compared with the final one (after 24 weeks of treatment).;Reduction of exudate. It will be evaluated through physical examination during the consultation and compared with the photographs during the follow-up time, as well as the team's notes in the patient's chart as a parameter, whether or not there was a reduction in the amount of exudate. The initial amount of exudate will be compared with the final one (after 24 weeks of treatment).

Countries

Brazil

Contacts

Public ContactTássia Bomfim

Fundação Universidade Federal de Sergipe

tassiaufs@gmail.com+55-79-21051876

Outcome results

None listed

Source: REBEC (via WHO ICTRP)