Limb Health and Socket Pressure in Response to Powered Ankle Protheses
Launched by INDIANA UNIVERSITY · Nov 4, 2021
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
Some estimates suggest that by 2050, as many as 3.6 million people in the United States will be living with limb loss, and at least 60% of them will have had at least a foot removed For military personnel, combat-related amputations remain one of the most common major disabling war-related injuries from modern armed conflict. Technological advancements in active prosthetic devices for individuals with transtibial amputation offer the potential for superior function in key areas that could lead to higher rates of RTD and improved quality of life. Currently intended primarily for individuals ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Ages 18 and above
- • Weight ≤ 280 lb
- • Ambulate at a K3 level or higher-level determined from patient EHR
- • At least 3 months post-amputation per physician discretion
- • Residual limb length greater than 4.5 inches
- • Use of a passive prosthesis
- • Unilateral transtibial amputees
- • Must be able to ambulate without any assistive devices
- • Subjects must be able to follow directions and give informed consent on their own
- Exclusion Criteria:
- • Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
- • Other amputees
- • Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
- • Women who are pregnant or who plan to become pregnant in the near future
- • Individuals diagnosed with renal failure
- • Participants unwilling to wear a cloth face covering for the duration of each visit
About Indiana University
Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Patients applied
Trial Officials
Sashwati Roy, PhD
Principal Investigator
Indiana University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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