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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT04441957
Eligibility Criteria:
Inclusion Criteria:
1. Patient age \> 18 years.
2. Current leg ulceration of greater than 6 weeks.
3. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
4. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
5. Able to give informed consent to participate in the study after reading the patient information documentation.
6. Ankle Brachial Pressure Index (ABPI) ≥ 0.8.
Exclusion Criteria:
1. Postoperative varicose veins disease recurrence.
2. Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
3. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
4. History of pulmonary embolism or stroke.
5. Current anticoagulation therapy (within 7 days of enrollment).
6. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04441957
Study Brief:
Protocol Section:
NCT04441957