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Prosthetic Suspension System

Prosthetic Suspension Systems for Lower Limb Prosthesis Wearers

N/A
Waitlist Available
Led By Glenn K Klute, PhD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulate without upper extremity aids
Able to walk for 30 minutes on a treadmill
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.
Awards & highlights

Study Summary

This trial is testing three different types of prosthetic suspension systems to see which one is most effective at maintaining a secure adherence when worn in conditions that result in profuse sweating.

Who is the study for?
This trial is for individuals with a single below-knee amputation who have been using their prescribed prosthesis for at least six months. They must be able to walk without hand support and use the prosthesis daily for more than four hours. Excluded are those with cognitive or language barriers, high heart disease risk, ill-fitting prostheses that can't be adjusted, current incarceration, pregnancy, skin issues on the limb, or walking impairments due to other conditions.Check my eligibility
What is being tested?
The study compares three lower limb prosthetic suspension systems: (1) standard prescribed prosthesis; (2) one with a perforated liner allowing sweat drainage; and (3) another featuring an air pump system expelling sweat. Participants will wear each type in various environments and undergo tests to measure slippage and comfort under simulated Middle East climate conditions.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing different prosthetic types or skin irritation due to varying levels of moisture management by each system. The impact on residual limb health when exposed to heat and humidity will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk without using my arms for support.
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I can walk for 30 minutes on a treadmill.
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I wear my prosthesis for at least 4 hours daily.
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I have been using a prosthesis for at least six months.
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I have had one lower leg amputated below the knee.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after wearing the study prosthesis in the home, work, and community environments for two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after wearing the study prosthesis in the home, work, and community environments for two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence
Expelled Perspiration
Secondary outcome measures
Satisfaction with the prosthesis: 11-point Likert scale
Skin hydration
Transepidermal water loss

Trial Design

2Treatment groups
Experimental Treatment
Group I: Field MeasurementsExperimental Treatment3 Interventions
All participants will wear all three study prostheses in their home, work, and community environments for two weeks.
Group II: Environmental ChamberExperimental Treatment3 Interventions
All participants will wear all three study prostheses in an environmental chamber set at 35 degrees Celsius and 50% relative humidity.

Find a Location

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
52 Previous Clinical Trials
13,375 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,674 Total Patients Enrolled
Glenn K Klute, PhDPrincipal InvestigatorDept. of Veterans Affairs
4 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Lower Extremity Amputation
40 Patients Enrolled for Lower Extremity Amputation

Media Library

As-prescribed prosthesis (Prosthetic Suspension System) Clinical Trial Eligibility Overview. Trial Name: NCT03900845 — N/A
Lower Extremity Amputation Research Study Groups: Environmental Chamber, Field Measurements
Lower Extremity Amputation Clinical Trial 2023: As-prescribed prosthesis Highlights & Side Effects. Trial Name: NCT03900845 — N/A
As-prescribed prosthesis (Prosthetic Suspension System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900845 — N/A

Frequently Asked Questions

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

To whom does eligibility for this research endeavor extend?

"The purpose of this trial is to recruit 25 individuals with transtibial amputations, aged between 18 and 70. To be eligible for the study, patients must satisfy a set of requisites: frequent prosthesis use throughout their day, independent ambulation without upper-limb assistance, 30 minutes on a treadmill walk test, and at least six months experience using their artificial limb."

Answered by AI

What is the approximate participant count of this trial?

"Affirmative. According to information on clinicaltrials.gov, this experiment is actively searching for potential participants. It was first published on February 17th 2019 and the details were last updated January 18th 2022 with a requirement of 25 individuals at one medical centre."

Answered by AI

Is there an age cutoff for eligibility in this research project?

"This clinical trial is seeking individuals aged 18 or older, but younger than 70 years old."

Answered by AI

Are there any current opportunities to join this clinical trial?

"As evidenced by clinicaltrials.gov, this trial is proactively enrolling participants. It was first listed on February 17th 2019 and recently edited on January 18th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
VA Puget Sound Health Care System Seattle Division
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Adherence and Perspiration While Wearing Lower Limb Prostheses
Glenn Klute 2019. "Adherence and Perspiration While Wearing Lower Limb Prostheses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900845.
~4 spots leftby Apr 2025
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