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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT06980961
Eligibility Criteria:
Inclusion Criteria:
1. Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
2. Agreement with the terms of the survey and signing of the informed consent form
3. Availability to make the necessary appointments for treatment and follow-up
4. Provide consent to avoid pregnancy during treatment
5. Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques
Exclusion Criteria:
1. Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
2. Peripheral arterial disease.
3. History of known allergy to the drugs used in this study
4. Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
5. Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.
6. Anyone who does not agree with any of the search terms.
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Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06980961
Study Brief:
Protocol Section:
NCT06980961