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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT07163312
Eligibility Criteria:
Inclusion Criteria:
Adults aged ≥18 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).
Presence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS/NRS ≥3 at baseline.
Planned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).
Ability to provide informed consent and complete study questionnaires.
Exclusion Criteria:
Prior surgery or endovenous ablation for varicose veins in the same limb. History of inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic rheumatologic disease.
Recent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (\<3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.
Severe peripheral arterial disease (ABI \<0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07163312
Study Brief:
Protocol Section:
NCT07163312