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NCT05124652 · ClinicalTrials.gov registry record · NA
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
A NA study of Lower Limb Amputation Below Knee (Injury) and Diurnal Residual Limb Fluid Volume Fluctuation, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05124652: Recruiting NA study of Lower Limb Amputation Below Knee (Injury) and Diurnal Residual Limb Fluid Volume Fluctuation, sponsored by University of Washington.
NCT05124652 is a NA study of Lower Limb Amputation Below Knee (Injury) and Diurnal Residual Limb Fluid Volume Fluctuation that is actively recruiting participants, run by University of Washington. The registered enrollment target is 100 participants, above the 67-participant average among 7 other Lower Limb Amputation Below Knee (Injury) trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05124652, a NA study of Lower Limb Amputation Below Knee (Injury) and Diurnal Residual Limb Fluid Volume Fluctuation, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
Primary Outcome
Participants in Aim 2 and Aim 3 will test various configurations of the auto adjustment algorithm. Socket comfort score will be asked at various time points during testing, and overall changes in this metric will be calculated from the start and end of session.
Conditions Studied
Interventions
- DEVICE Auto Adjusting Prosthesis
Study Locations (1)
Washington
- William H. Foege Hall - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05124652 shows while recruiting
NCT05124652 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 67-participant average among 7 other Lower Limb Amputation Below Knee (Injury) trials with a reported enrollment target (49% higher).
The record links to 2 conditions, with Lower Limb Amputation Below Knee (Injury) appearing as the primary indexed condition, and to 1 intervention - of which Auto Adjusting Prosthesis is the first listed.
NCT05124652 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05124652 about?
NCT05124652 is a clinical study titled "An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation". People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help add...
What is the current status of trial NCT05124652?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-10-18. Estimated completion is 2027-06.
What conditions does trial NCT05124652 study?
This clinical trial studies the following conditions: Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation.
What interventions are being tested in trial NCT05124652?
The interventions under investigation include: Auto Adjusting Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT05124652?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05124652 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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