NIH Release/Relock Socket
Launched by UNIVERSITY OF WASHINGTON · Mar 9, 2020
Trial Information
Current as of August 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the NIH Release/Relock Socket, is studying a new technology designed to help manage changes in fluid levels in the residual limb of individuals who have had a lower limb amputation below the knee. This fluctuation can affect comfort and the fit of prosthetic legs, so the researchers want to see if their new approach can improve day-to-day living for those who use prosthetics.
To be eligible for this trial, participants should be between the ages of 65 and 74, have had a below-knee amputation for at least 18 months, and currently wear a prosthetic leg for at least 7 hours a week. They should also be able to walk with the prosthetic for at least 2 minutes at a time and perform basic movements like sitting and standing. Participants will be recruited for both in-person and remote involvement, with remote participants needing a spare prosthesis and good communication skills for video calls. Those interested should note that anyone with current skin problems or who doesn’t meet the eligibility criteria will not be able to participate. If you join, you can expect to learn more about how this new technology might help improve your comfort and mobility with your prosthetic leg.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Had trans-tibial amputation at least 18 months prior to enrollment
- • Regularly wear a definitive prosthesis for at least 7 hours per week
- • Have a residual limb length of at least 9 cm
- • K2 or higher MFCL
- • Able to walk continuously with a prosthesis for at least 2 minutes at a time
- • Sit, stand, and negotiate a step of 5.0 cm
- Participants involved remotely will have to meet the following inclusion criteria:
- • Have a spare prosthesis
- • No cognitive issues
- • Good hand dexterity and strength (not frail)
- • Capable of communication over a video Zoom conference call.
- Exclusion Criteria:
- • Current presence of skin breakdown
- • Unable to satisfy inclusion criteria
About University Of Washington
The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Patients applied
Trial Officials
Joan E Sanders, PhD
Principal Investigator
University of Washington
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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