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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT01817218
Eligibility Criteria:
Inclusion Criteria:
* Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
* Men or women of 40 to100 years of age
* Patients with stage C6 chronic venous insufficiency according to the CEAP classification
* Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
* Patients who present an analytical before entering the study with a normal range of number of platelets, red blood cells and hematocrit
* An ulcer of 3-5 cm in diameter
* An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
* Independent patients or with sufficient family support
* Patients have given written informed consent
Exclusion Criteria:
* Patients with chronic treatment with immunosuppressive or retroviral drugs
* Coagulopathies
* Patients with chronic infectious diseases
* Patients under radiotherapy or chemotherapy
* Patients with a history of neoplasia
* Patients with more than two active ulcers
* Pregnant women
* Patients with active cellulitis or fever
* An ABI of less than 0.8 or more than 1.5.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01817218
Study Brief:
Protocol Section:
NCT01817218