Status:
COMPLETED
Effect of Compressive Therapies on the Healing of Venous Ulcers
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Casex Innovation in Healthcare
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Venous Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatmen...
Detailed Description
The primary objective is to compare the effect of two compressive therapies, high compression elastic bandage and Unna boot, on time and on the healing characteristics of venous ulcers in Primary Heal...
Eligibility Criteria
Inclusion
- people with diagnosis of chronic venous insufficiency recorded in medical records, with active venous ulcer;
- with indication of compressive therapy, who are not using any of the therapies used in the study and who have not used them within 30 days of the initial moment of data collection;
- 18 years old or older;
- with Ankle-Brachial Index (ABI) between 0.8 and 1.2;
- with pulses present on palpation in lower limbs;
- walking people;
- with Body Mass Index (BMI) between ≥ 18.5 kg/m2 and 39.9 kg/m2 (for elderly people: ≥ 22 kg/m2 and 39.9 kg/m2);
- with ankle circumference greater than 18cm.
Exclusion
- pregnant women;
- people with mixed, infected or in the epithelialization phase UV (with epithelial tissue in 90% of the UV area);
- uncontrolled diabetics (with Glycated Hemoglobin greater than 7% in the last six months);
- people with medical diagnosis of dermatological, rheumatological and oncological diseases in the member of the active UV or immunosuppressive diseases (for influencing the healing process);
- with allergy to any f the components of the compressive therapies used in the study;
- people using immunosuppressants and/or corticosteroids for more than 21 days (for influencing the healing process).
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04703569
Start Date
December 2 2020
End Date
April 20 2023
Last Update
September 28 2023
Active Locations (3)
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1
Unidade de Saúde Modelo
Porto Alegre, Rio Grande do Sul, Brazil
2
Unidade de Saúde Santa Cecília
Porto Alegre, Rio Grande do Sul, Brazil
3
Unidade de Saúde Santa Marta
Porto Alegre, Brazil