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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT01440634
Eligibility Criteria:
Inclusion Criteria:
Cross-Sectional phase:
* Hispanic men and women aged 70 years or older.
* Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
* Individual has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by UT Southwestern Institutional Review Board.
Randomization phase:
* Hispanic men and women aged 70 years or older
* English or Spanish speaking
* Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
* Documented peripheral arterial disease with an Ankle-brachial index (ABI) \< 0.9 or Toe-brachial index (TBI) \<0.7, and abnormal Pulse Volume Recordings (PVR).
* Ability to ambulate independently.
* No prior amputations other than toe or partial foot amputations that do not impede walking.
* Patient has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by the UT Southwestern Institutional Review Board.
Exclusion Criteria:
Cross-Sectional Phase
* Individuals with severe dementia.
* Individuals with inability to provide informed consent.
* Bilateral lower or upper extremities amputations.
* Pregnancy or lactation. Randomization Phase
* Non-ambulatory
* Individuals with prior below- or above-knee amputations
* Individuals unable to give informed consent
* Individuals unwilling to perform the functional tests or quality of life assessments
* Individuals unable to perform exercise therapy, functional tests or quality of life assessments due to severe comorbidities
* Presence of concurrent illness with an anticipated life expectancy less than six months
* Individuals with planned operative interventions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01440634
Study Brief:
Protocol Section:
NCT01440634