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Prosthetic Suspension System
Prosthetic Suspension Systems for Lower Limb Amputation
N/A
Recruiting
Led By Jason Maikos, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral transtibial amputation (any etiology)
At least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post socket fit
Awards & highlights
Study Summary
This trial will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket, in order to compare the efficacy of two different prosthetic suspension systems.
Who is the study for?
This trial is for adults over 18 with a below-the-knee amputation who have been using a prosthetic limb for at least six months. It's not suitable for those with severe skin conditions, neuropathy, uncontrolled diabetes, mental impairments that affect compliance, or women who are pregnant or planning pregnancy during the study.Check my eligibility
What is being tested?
The study aims to measure how much the remaining lower leg moves inside two types of prosthetic sockets using dynamic stereo x-ray imaging. Participants will try both suction suspension and elevated vacuum suspension systems to see which reduces limb movement better.See study design
What are the potential side effects?
There may be minimal side effects from participating in this trial as it involves non-invasive imaging and testing different prosthetic fits rather than medication or surgery. However, discomfort from wearing different socket suspensions could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one of my lower legs amputated below the knee.
Select...
I am 18 years old or older.
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I use a prosthetic for at least 6 hours every day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks post socket fit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post socket fit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in dynamic residual tibia kinematics between suspension techniques
Changes in dynamic skin deformation of the residual limb between suspension techniques
Trial Design
2Treatment groups
Active Control
Group I: Suction Suspension FirstActive Control1 Intervention
The residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.
Group II: Elevated Vacuum Suspension FirstActive Control1 Intervention
The residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,263 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
20 Patients Enrolled for Lower Limb Amputation
Rutgers UniversityOTHER
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2,804,072 Total Patients Enrolled
University of Rhode IslandOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot wear the socket suspensions comfortably.You have a mental condition that makes it difficult for you to follow the study requirements.I am not pregnant and do not plan to become pregnant during the study.I have severe nerve pain, uncontrolled diabetes, no feeling in my foot, severe phantom pain, or a history of serious skin ulcers.You have another health condition that could affect or disrupt the study.I have severe circulation issues, like blocked blood vessels or swelling in my legs.The size of your remaining limb is not suitable for certain tests and fittings.I cannot walk on a treadmill at a slow or moderate pace.I have had one of my lower legs amputated below the knee.I am 18 years old or older.It has been over 6 months since my amputation.I use a prosthetic for at least 6 hours every day.I have skin issues or severe tightness that stopped me from using a prosthetic before.I do not have mental health issues that would prevent me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Suction Suspension First
- Group 2: Elevated Vacuum Suspension First
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for individuals to participate in this trial at the present moment?
"As detailed on clinicaltrials.gov, this medical trial is no longer actively recruiting patients; the original posting date was July 1st 2023 and there were edits made as recently as March 9th 2022. There are still other studies in need of participants though."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Poorly fitting sockets causing pain and skin breakdown on residual limb.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY: < 48 hours
Average response time
- < 2 Days
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