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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT02790593
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years old
* Active venous ulcer for \>2 weeks but \<1 year
* 1cm squared surface area
* Venous incompetence confirmed by clinical assessment and duplex ultrasound scan
* No evidence of arterial disease (Arterial Duplex or Ankle Brachial Pressure Index \>0.9)
* Patients able to complete trial procedures
* Patients with a life expectancy of greater than 1 year
Exclusion Criteria:
* Age less than 18 years
* Significant arterial disease (Ankle Brachial Pressure Index \<0•9 or evidence on Arterial Duplex)
* Acute Deep Vein Thrombosis
* Patient unable or unwilling to have high compression (30mmHg minimum)
* Patients with dexterity insufficiency of hands
* Patients with peripheral neuropathy
* Leg ulcers of another underlying cause
* Leg ulcers of greater than 1 year duration
* Patients unable or unwilling to provide written, informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02790593
Study Brief:
Protocol Section:
NCT02790593