NCT05124652 An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
| NCT ID | NCT05124652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Lower Limb Amputation Below Knee (Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-10-18 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-10-18 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
* 18 years or older * Unilateral or bilateral trans-tibial amputation at least 12 months prior * Have a limb of length 9 cm or greater * Are capable of at least 5 minutes of continuous walking * Are capable of at least 1 hour of intermittent walking * Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads * Have adequate sensation to verbalize a socket that is too large or too small to be tolerated * Do not regularly use assistive devices (e.g., cane, walker) for ambulation * Do not have open wounds on their residual limb at the time of enrollment
Contact & Investigator
Joan E Sanders, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05124652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Limb Amputation Below Knee (Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05124652 currently recruiting?
Yes, NCT05124652 is actively recruiting participants. Contact the research team at kate@allyn.org for enrollment information.
Where is the NCT05124652 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05124652 clinical trial?
NCT05124652 is sponsored by University of Washington. The principal investigator is Joan E Sanders, PhD at University of Washington. The trial plans to enroll 100 participants.