Status:
COMPLETED
Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated with major detr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01440634
Start Date
February 1 2008
End Date
February 1 2013
Last Update
December 29 2015
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390