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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01007604
Eligibility Criteria:
Inclusion Criteria:
* Consistent claudication symptoms for at least 6 months
* ABIs at rest as follows: 0.5\>ABI\<0.8 minimally on one leg
Exclusion Criteria:
* Refuses to consent
* Unlikely to be compliant with protocol
* Unable to perform treadmill test
* Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
* Lower extremity surgery or endovascular procedure within the last 3 months
* Currently has a non-healing wound on either leg
* DVT in the past 3 months
* Unstable hypertension, angina, uncontrolled glucose levels
* Participating in a supervised exercise regimen
* Claudication medications regime changed within the last 3 months
* Diagnosis of Raynaud's Disease
* Requires a custom fabricated boot appliance
* Single limb amputees meeting inclusion criteria may participate in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01007604
Study Brief:
Protocol Section:
NCT01007604