AmputationNCT04725461
Low Cost Socket for Lower Limb Amputees
A study testing Low cost lower limb prosthetic socket in people with Amputation and Amputation; Traumatic, Limb, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation, Amputation; Traumatic, Limb, Amputation, Traumatic
- What is being tested?
- Low cost lower limb prosthetic socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2018to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
- Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
- K2, K3, K4 level ambulators
- Understands the English language
Who cannot join
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
- 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.
- Bulbous residual limb shape causing inability to fit within system restrictions
- Open wounds on the residual limb
- Inability to understand the English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Cost Prosthetic Socket for Lower Limb Amputees
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries.
To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.
Read the detailed description
Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clinician training programs. The first step in fitting a prosthetic limb is to fabricate the socket, which fits over the residual limb and acts as the interface between the residual limb and the prosthesis. The socket is the most custom component of the prosthetic system and must be comfortable to wear, easy to clean, and durable enough to withstand years of day-to-day use.
Simple and low-cost methods for socket fabrication and fitting would improve access to prosthetic care and could give many people in need their first opportunity to use a prosthesis. We have developed an easy-to-follow method that allows us to cast the limb in less than 30 minutes and finish the socket in 90 minutes, making it a practical choice for socket fitting in busy clinical settings, and where users are unable to return for multiple fittings. We have submitted a provisional US patent for our socket fabrication method.
We hypothesize that our novel method of fabrication for a low cost prosthesis can produce a device that has appropriate suspension, a comfortable interface, and requires little long term follow-up.
- Being tested
- Low cost lower limb prosthetic socket
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low cost lower limb prosthetic socketDevice
A pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder.
A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Low cost lower limb socket testing | Experimental | 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. Receives: Device: Low cost lower limb prosthetic socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket Comfort Score with Experimental Low Cost Socket
The Socket Comfort Score will be used with the experimental low cost socket. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures
Measured: Day 2
Socket Comfort Score with Clinically Prescribed Socket
The Socket Comfort Score will be used with the subjects clinically prescribed prosthetic system. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures
Measured: Day 2
Secondary outcomes (4)
Four Square Step Test
A clinical test of the ability to change directions while stepping.
Measured: Day 2
L-Test of Functional Mobility
The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns.
Measured: Day 2
2 Minute Walk Test
Individual walks without assistance for 2 minutes and the distance is measured.
Measured: Day 2
Amputee Mobility Predictor
A questionnaire that measures the ambulatory potential of lower limb amputees. It requires the amputee to complete various tasks. Including sitting balance, reaching, transfers, sit to stand, and standing balance,
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start6 Jul 2018
- Primary completion11 Jan 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Miller, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725461
- Sponsor's protocol ID
- STU00207623
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Cost Prosthetic Socket for Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT04725461
- Acronym / sponsor ID
- STU00207623
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries.
To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.
Detailed description
Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clinician training programs. The first step in fitting a prosthetic limb is to fabricate the socket, which fits over the residual limb and acts as the interface between the residual limb and the prosthesis. The socket is the most custom component of the prosthetic system and must be comfortable to wear, easy to clean, and durable enough to withstand years of day-to-day use.
Simple and low-cost methods for socket fabrication and fitting would improve access to prosthetic care and could give many people in need their first opportunity to use a prosthesis. We have developed an easy-to-follow method that allows us to cast the limb in less than 30 minutes and finish the socket in 90 minutes, making it a practical choice for socket fitting in busy clinical settings, and where users are unable to return for multiple fittings. We have submitted a provisional US patent for our socket fabrication method.
We hypothesize that our novel method of fabrication for a low cost prosthesis can produce a device that has appropriate suspension, a comfortable interface, and requires little long term follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low cost lower limb socket testing | Experimental | Device: Low cost lower limb prosthetic socketFabrication 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 may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
- Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
- K2, K3, K4 level ambulators
- Understands the English language
Key exclusion criteria (5 listed)
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
- 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.
- Bulbous residual limb shape causing inability to fit within system restrictions
- Open wounds on the residual limb
- Inability to understand the English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low cost lower limb prosthetic socketA pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder. A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis. | Device | Low cost lower limb socket testing |
Primary outcome
Socket Comfort Score with Experimental Low Cost Socket
Time frame: Day 2
The Socket Comfort Score will be used with the experimental low cost socket. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures
Socket Comfort Score with Clinically Prescribed Socket
Time frame: Day 2
The Socket Comfort Score will be used with the subjects clinically prescribed prosthetic system. This measure allows the subject to subjectively rate how comfortable they perceive their socket on a scale of 1 to 10, and will be administered pre and post physical outcome measures
4 secondary outcomes
Four Square Step Test
Time frame: Day 2
L-Test of Functional Mobility
Time frame: Day 2
2 Minute Walk Test
Time frame: Day 2
Amputee Mobility Predictor
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low cost lower limb prosthetic socket in people with Amputation and Amputation; Traumatic, Limb, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socket Comfort Score with Experimental Low Cost Socket (time frame: Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.