Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT04703569
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04703569
Study Brief:
Protocol Section:
NCT04703569