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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Integral Absolute Error of Control System

Socket Comfort Score

Secondary study objectives

Percent change in Limb Fluid Volume

Thermal Recovery Time (TRT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met