Auto Adjusting Prosthesis for Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amputation+1 More
Auto Adjusting Prosthesis - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Amputation
  • Diurnal Residual Limb Fluid Volume Fluctuation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
Integral Absolute Error of Control System
Percent change in Limb Fluid Volume
Socket Comfort Score
Thermal Recovery Time (TRT)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Focus Group Testing
1 of 3
Out-of-Lab Crossover Study
1 of 3
In-Lab, Crossover Study
1 of 3
Active Control
Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Auto Adjusting Prosthesis · No Placebo Group · N/A

Out-of-Lab Crossover Study
Device
Experimental Group · 1 Intervention: Auto Adjusting Prosthesis · Intervention Types: Device
In-Lab, Crossover Study
Device
Experimental Group · 1 Intervention: Auto Adjusting Prosthesis · Intervention Types: Device
Focus Group TestingNoIntervention Group · 1 Intervention: Focus Group Testing · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,583 Previous Clinical Trials
1,565,886 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,805 Previous Clinical Trials
2,235,143 Total Patients Enrolled
Joan E Sanders, PhDPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
240 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to distinguish socket sizes too large and too small to be tolerated.
You have had a trans-tibial amputation at least 12 months prior.
You have experienced limb volume fluctuation in the past.
You have residual limb length of at least 9 cm.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.