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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT05335161
Eligibility Criteria:
Inclusion Criteria:
* Men and women 60 years or older
* Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg.
* Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.
Exclusion Criteria:
* Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
* Prior amputation
* Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
* Recent (\<3 months) lower-extremity revascularization or orthopedic surgery
* Use of walking aid other than a cane
* Active cancer
* Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
* Unable to fit into water-circulating trousers
* A Mini-Mental Status Examination score \<23
* Impaired thermal sensation in the leg
* Age lower than 60 yrs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05335161
Study Brief:
Protocol Section:
NCT05335161