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Therapeutic Ultrasound associated with the application of copaiba and tea tree oil in the treatment of leg ulcers: a controlled and randomized clinical study

Low Frequency Ultrasound associated to application of Copaíba and Melaleuca Oil in process of healing of Venous Ulcers: Controlled and Randomized Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4pjmbb
Enrollment
Unknown
Registered
2020-06-03
Start date
2016-10-01
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, Varicose veins of other specified sites

Interventions

The sample consisted of five participants, totaling 14 venous ulcers, which were randomly distributed. In the control group, Essential Fatty Acids (AGE) were extracted from copaiba and tea tree oil. I
Device

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Individuals over 18 years of age; To present venous ulcer; To attend the outpatient clinic on pre-established days, for at least 10 days after the start of the intervention; To present glycemic control, without the use of anti-inflammatory medication by any route of absorption.

Exclusion criteria

Exclusion criteria: Present necrotic tissue with indication of limb amputation; Under treatment by radiotherapy; Wounds due to radiotherapy; Pregnant patients; Patients with metallic implants in the region; Diagnosis of deep venous thrombosis; Hemophiliac patients or those at risk of hemorrhage; Smoking patients; Patients on corticosteroids; Diabetic patients; Use unna's boot as a treatment.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Increased healing of venous ulcers, verified by assessing the area of the lesion in the photographic record during follow-up and by evaluating specialists based on the observation of a complete healing in the pre- and post- intervention.;Outcome found 1: Increased healing of venous ulcers, verified by assessing the area of the lesion in the photographic record during follow-up and by evaluating specialists based on the observation of a reduction in the area of the lesion in the pre- and post- intervention.

Secondary

MeasureTime frame
Expected outcome 1: Decrease in necrosis tissue, verified by assessing the presence of tissues in the lesion after the removal of primary coverage from the finding of complete absence or reduction of the proportion in relation to the total area of the lesion in the pre and post-intervention.;Outcome found 1: Decrease in necrosis tissue, verified by assessing the presence of tissues in the lesion after the removal of primary coverage from the finding of complete absence or reduction of the proportion in relation to the total area of the lesion in the pre and post-intervention.;Expected outcome 2: Decrease in edema, verified by assessing the presence of edema in the entire injured limb registered with the cross symbol (+), after the removal of the primary coverage from the finding of complete absence or partial reduction in measurements pre and post-intervention.;Outcome found 2: Decrease in edema, verified by assessing the presence of edema in the entire injured limb registered with the cross symbol (+), after the removal of the primary coverage from the finding of complete absence or partial reduction in measurements pre and post-intervention.;Expected outcome 3: Decrease in pain, verified before the start of each intervention based on the reduction of scores on the Visual Analogue Scale (scores from 0 to 10, where: 0 no pain and 10 worst possible pain) in the pre and post-intervention measurements.;Outcome found 3: Decrease in pain, verified before the start of each intervention based on the reduction of scores on the Visual Analogue Scale (scores from 0 to 10, where: 0 no pain and 10 worst possible pain) in the pre and post-intervention measurements.;Expected outcome 4: Decreased exudation, verified by observing the amount of secretion present in the gauze and the lesion after the removal of the primary cover, based on the reduction of scores (0 is none; 1 is scarce; 2 is moderate; 3 abundant) in pre- and post-intervention measurements.;Outcome found 4: Decreased

Countries

Brazil

Contacts

Public ContactLuana Caldini

Universidade Federal do Ceará

caldiniluana@gmail.com+55-085-997199981

Outcome results

None listed

Source: REBEC (via WHO ICTRP)