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Prosthetic Socket System

Auto-Adjusting Prosthetic Socket for Below Knee Amputation

N/A
Recruiting
Led By Joan E Sanders, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 or older (Prosthetists and Prosthesis Users)
Must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a system that would automatically adjust the fit of a prosthetic socket for people with leg amputations, to help with common issues like pain and skin breakdown.

Who is the study for?
This trial is for adults who have had a below-knee amputation at least one year ago, regularly use a definitive prosthesis with pin lock suspension, and experience daily limb size changes. Certified prosthetists treating such patients can also participate. People using walking aids, with reduced skin sensation or neuropathy, or current sores on their residual limb cannot join.Check my eligibility
What is being tested?
The study tests an auto-adjusting prosthetic socket designed to automatically adapt to daily volume changes in the residual limbs of people with transtibial amputations, aiming to improve fit and comfort without manual adjustments.See study design
What are the potential side effects?
Potential side effects may include discomfort due to improper fitting during the adjustment phase and possible skin irritation as the new system adapts to limb volume fluctuations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older and use a prosthesis.
Select...
I am certified and treat patients with below-knee amputations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Integral Absolute Error of Control System
Socket Comfort Score
Secondary outcome measures
Percent change in Limb Fluid Volume
Thermal Recovery Time (TRT)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Out-of-Lab Crossover StudyExperimental Treatment1 Intervention
Evaluate socket performance in user free-living environments. Participants will use the prosthesis in all modes by end of study, order will be randomly assigned.
Group II: In-Lab, Crossover StudyExperimental Treatment1 Intervention
Testing of auto-adjusting algorithm in-lab. Participants will carry out a structured protocol wearing the socket in all modes. Order will be randomly assigned.
Group III: Focus Group TestingActive Control1 Intervention
Focus group testing of key-fob device to control adjusting socket system

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,570 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,630 Total Patients Enrolled
Joan E Sanders, PhDPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
294 Total Patients Enrolled

Media Library

Auto Adjusting Prosthesis (Prosthetic Socket System) Clinical Trial Eligibility Overview. Trial Name: NCT05124652 — N/A
Below Knee Amputation Research Study Groups: Focus Group Testing, In-Lab, Crossover Study, Out-of-Lab Crossover Study
Below Knee Amputation Clinical Trial 2023: Auto Adjusting Prosthesis Highlights & Side Effects. Trial Name: NCT05124652 — N/A
Auto Adjusting Prosthesis (Prosthetic Socket System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05124652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can partake in this trial at its highest capacity?

"Indeed, according to the data hosted on clinicaltrials.gov, this medical trial is presently accepting applicants. This investigation was submitted on October 18th 2021 and most recently updated September 26th 2022; with a target of 100 patients at 1 location."

Answered by AI

Has the enrollment window for this investigation been opened?

"Affirmative. Clinical trials dot gov states that this investigation is actively seeking enrolment, which begun on October 18th 2021 and was last revised on September 26 2022. The experiment requires a hundred participants from one single site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
William H. Foege Hall
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

What questions have other patients asked about this trial?

Would this trial help aid in weight loss? How often are in person visits? Are all expenses provided?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Joan Sanders 2021. "An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05124652.
~51 spots leftby Dec 2026
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