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Search / Trial NCT05112679

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.

Locations

Indianapolis, Indiana, United States

Patients applied

0 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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