NIH Release/Relock Socket

Status unconfirmed · Not applicable

Conditions studied: Lower Limb Amputation Below Knee (Injury)

In brief

The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.

Key facts

Study ID

NCT04305782

Run by

University of Washington

People needed

100

Starts

2020-09-01

Expected to finish

2025-09-30

Last updated by the study team

2024-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Current presence of skin breakdown
• Unable to satisfy inclusion criteria

Where it is running

• University of Washington Bioengineering — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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