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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT03429959
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Male or postmenopausal female patient, aged over 65 years of age
* Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)
Exclusion Criteria:
* Venous leg ulcer with a surface \>5cm2
* Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index \<0.8 or \>1.3)
* Difference in brachial blood pressure \>20mmHg in both arms
* Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test
* Inability to reach the forefoot with their hands
* Inability to follow the procedures of the study
* Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03429959
Study Brief:
Protocol Section:
NCT03429959