Low Cost Prosthetic Socket for Amputation

Overseen By Laura Miller, PhD, CP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cognitive impairment, Stroke, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new, low-cost prosthetic socket for individuals with below-knee amputations. The researchers seek to determine if this socket, made with expandable foam, provides comfort and functionality for those who have lost a leg. The trial seeks participants who had their amputation at least six months ago, can walk independently, and currently use a comfortable prosthetic. This research could particularly benefit individuals in developing countries who require affordable prosthetic solutions. As an unphased trial, this study offers a unique opportunity to contribute to the development of accessible prosthetic technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a prosthetic socket, so it might not require changes to your medication, but it's best to ask the trial organizers for confirmation.

What prior data suggests that this fabrication method is safe for amputees?

In a previous study, researchers investigated the use of expandable rigid foam for prosthetic sockets. This method showed promise in creating comfortable and functional sockets for individuals with lower leg amputations. The foam expands to fit the limb's shape, enhancing comfort and fit.

Although detailed safety information for this specific socket type is not available, prosthetic materials are generally well-tolerated. This foam method is innovative and aims to make prosthetics more affordable without sacrificing comfort.

If successful, this foam-based socket could greatly benefit many people, particularly in developing countries. As with any new treatment, monitoring for unexpected issues is crucial, but current research suggests it is designed to be safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-cost lower limb prosthetic socket because it offers an affordable alternative to traditional prosthetic sockets, which can be quite expensive. Unlike standard options that may sacrifice comfort or functionality due to cost constraints, this new socket aims to provide proper suspension, comfort, and function specifically for transtibial amputees. By making high-quality prosthetics more accessible, this innovation has the potential to significantly improve the quality of life for many individuals who might otherwise be unable to afford effective prosthetic solutions.

What evidence suggests that this fabrication method is effective for comfort and function in transtibial amputees?

Research has shown that the new low-cost prosthetic leg socket, tested in this trial, matches the comfort of traditional ones. Users in studies expressed satisfaction with the results, with some finding the sockets suitable for home use. This indicates that the new design is effective for individuals with below-the-knee amputations. The use of expandable rigid foam reduces costs, offering an affordable option without compromising quality. Although still under trial, these findings suggest this prosthetic could benefit amputees, particularly in developing countries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for unilateral transtibial amputees who had their amputation at least 6 months ago, can walk independently, and currently have a comfortable prosthesis. Participants must be able to understand English but cannot join if they have cognitive impairments, significant other health issues, certain limb shapes that don't fit the system, open wounds on the limb, or can't understand English.

Inclusion Criteria

I had one lower leg amputated over 6 months ago and can walk on my own.

I can walk with some assistance or independently.

Your prosthetic limb fits well and you have given it a comfort score of at least 6 out of 10.

Exclusion Criteria

Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.

I understand and can follow the study's requirements.

I have open wounds on the limb that was amputated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fabrication and Testing

Fabrication and testing of a low cost lower limb prosthetic socket to ensure appropriate suspension, comfort, and function for a transtibial amputee

1 day

1 visit (in-person)

Outcome Measures Assessment

Assessment of functional mobility and comfort using various tests such as the L-Test of Functional Mobility, Amputee Mobility Predictor, and Socket Comfort Score

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial testing

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low cost lower limb prosthetic socket

Trial Overview The study tests a new low-cost method for making prosthetic sockets using expandable rigid foam. This could help amputees in developing countries get quality prosthetics. The comfort and function of this new socket are being compared to current options.

How Is the Trial Designed?

Group I: Low cost lower limb socket testing Experimental Treatment 1 Intervention

Fabrication and testing of a low cost lower limb prosthetic socket and ensure this socket has appropriate suspension, comfort and f unction for a transtibial amputee.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5218541/

ECONOMIC EVALUATIONS OF INTERVENTIONS FOR ... Estimated lifetime prosthetic costs for an individual with unilateral lower limb amputation could range from $0.5 to $1.8 million depending on many factors, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04725461

NCT04725461 | Low Cost Socket for Lower Limb Amputees Fabrication and testing of a low cost lower limb prosthetic socket and ensure this socket has appropriate suspension, comfort and f unction for a transtibial ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012334

Evaluating the Effectiveness of Transtibial Prosthetic ... The study demonstrates promising results for using an AI algorithm in prosthetic socket design, but long-term effectiveness and refinement for improved comfort ...

4. rehab.jmir.org rehab.jmir.org/2025/1/e69962

Evidence-Generated Sockets for Transtibial Prosthetic Limbs ... Results: EG sockets had no statistically significant difference in comfort compared with clinician-led control sockets (median SCS 8.6 for EG ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(24)01233-4/pdf

Evaluating the Effectiveness of Transtibial Prosthetic ... Outcome measurements Eight out of 10 DMSD-prosthetic sockets and all 10 MMD-pros- thetic sockets were deemed satisfactory and could be tested at home.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397974/

The Impact of Limited Prosthetic Socket Documentation In this article, the concerns, issues and consequences arising from lack of upper and lower limb socket documentation are discussed from a researcher ...

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01270-0

Adjustable prosthetic sockets: a systematic review of ... This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume ...

8. mdpi.com mdpi.com/2673-1592/6/3/33

An Innovative Solution for Lower Limb Prosthetic Sockets This study utilises self-reinforced PET (polyethylene terephthalate), an affordable and sustainable composite material, to produce custom-made sockets.

9. es.aetna.com es.aetna.com/cpb/medical/data/500_599/0578.html

Lower Limb Prostheses - Medical Clinical Policy Bulletins Aetna considers lower limb prostheses medically necessary for performing normal daily activities when the following criteria are met.