Status:
COMPLETED
Dysvascular Amputation Self-Management of Health
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Amputation
Diabetes Mellitus
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
Detailed Description
Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examine...
Eligibility Criteria
Inclusion
- Within the age range of 50-85 years
- Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
- Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
- Participant goal of household walking or better using a prosthesis
Exclusion
- Trauma or cancer-related etiology of the LLA
- Decisionally challenged individuals (MMSE score below 24)
- Prisoners
- Active cancer treatment
- Recent stroke (within 2 years)
- Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04083456
Start Date
November 1 2019
End Date
May 31 2025
Last Update
July 29 2025
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045