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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00202267
Eligibility Criteria:
Inclusion Criteria:
* clinical presentation of venous insufficiency
* leg ulcer equal to or larger than 0.7 cm in any one dimension
* ulcer a minimum duration of 1 week
* ankle brachial pressure index equal to or greater than 0.80
* participant can provide written consent
* participant can communicate in English, or translation available
* participant 18 years or over
Exclusion Criteria:
* diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
* participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
* previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
* symptoms of cognitive impairment noted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00202267
Study Brief:
Protocol Section:
NCT00202267