Transtibial AmputeesNCT07329738
Single-Subject Research Design on 3D-Printed Prosthetic Sockets
A study testing 3D printed prosthetic sockets in people with Transtibial Amputees, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this single-subject research design (clinical trial) is to assess the functionality of the 3D printed prostheses and to compare them to the existing prostheses in terms of mobility, balance, utility, and comfort. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Transtibial Amputees
- What is being tested?
- 3D printed prosthetic sockets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2023to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are adults 19+ years,
- have a unilateral or bilateral transtibial amputation,
- have an existing definitive prosthesis,
- use their definitive prosthesis two or more consecutive hours per day,
- have no wounds on the residual limb.
Who cannot join
- are unable to adequately complete self-report measures or communicate well enough to participate in the end of project interview,
- have bilateral upper extremity amputations,
- have poorly controlled comorbidities (e.g., unstable diabetes, advanced heart problems)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: A 3D-Printed Prosthesis Portable Station: The Vancouver Limbkit Project
The goal of this single-subject research design (clinical trial) is to assess the functionality of the 3D printed prostheses and to compare them to the existing prostheses in terms of mobility, balance, utility, and comfort. Participants who have a unilateral or bilateral transtibial amputation wear their existing prosthesis for roughly 3 weeks, followed by 3 weeks wearing a 3D printed prosthesis. The research assistants collect data throughout each period remotely, with the exception of one in-person visit to participants' homes to prepare the setting for the virtual evaluation sessions.
Read the detailed description
Once a participant is recruited and consent is obtained, Phase (A) begins with the research assistants conducting one home visit with the participant. This visit sets up the performance-based outcome measures, provides instructions for performing the tests, explains how to complete the online surveys, and clarifies how to take the video recordings. The research assistants distribute the Sociodemographic and Clinical Characteristics questionnaire to the participant via the UBC Qualtrics platform.
During Phase (A), the participant wears their definitive prosthesis and is remotely evaluated up to three times per week for three weeks. At the end of Phase (A), the participant receives an online self-reported survey to measure the utility of using the definitive prosthesis.
The participant then attends their prosthetic clinic to have measurements and a scan of their residual limb taken for the 3D printed prosthesis. The prosthetists use the "Comb" mobile scanner application, and the scans of the participants are securely stored and de-identified to maintain the confidentiality of the participants' information through the HIPAA-compliant Comb portal. The research assistant prints the prosthesis, which includes implanting a thermal sensor into the prosthesis to monitor the wear time. The participant visits the prosthetic clinic a second time to have the 3D printed prosthesis fitted by the relevant prosthetist in the team. The prosthetist ensures the new prosthesis is properly fitted and appropriate for use before allowing the participant to go home with it.
In Phase (B), the participant uses the 3D-printed prosthesis for three weeks and conducts the same outcome measures. At the end of Phase (B), the participant receives an online self-reported survey to measure the utility of using the 3D printed prosthesis.
Participants drop off the 3D-printed prostheses at their prosthetic clinics at the end of the study. Then the RA collects all the 3D printed prostheses to keep them in a locked cabinet in the principal investigator's office at the University of British Columbia.
The participant then has a one-to-one virtual semi-structured interview to explore their experiences with the 3D printed prosthesis.
A separate focus group is conducted with prosthetists involved in this study to obtain their feedback and suggestions regarding the Limbkit.
- Conditions
- Transtibial Amputees
- Being tested
- 3D printed prosthetic sockets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed prosthetic socketsDevice
The sockets are 3D printed using Polyethylene Terephthalate Glycol (PETG) filament. The printer used for this process is the Fused Deposition Modelling (Creality Ender 6), equipped with a 1.0 mm nozzle diameter, a print speed of 45mm/s, and a layer thickness of 2 mm. To enhance their strength, the sockets are reinforced with Delta-Lite® plus cast tapes and assembled using a distal push-lock mechanism and plate. The number of reinforcement wraps of the Delta-Lite® differs for each region of the socket. Below the sockets, the same prosthetic components from the previous prosthesis are utilized where possible. Participants wear their 3D printed sockets for an adjustment period (3-7 days) and then come in for a follow-up session to ensure the 3D socket still fits well after their limb has settled into the new system. Once both the prosthetist and participant are happy with the fit, Phase B testing is scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Single group (one arm only) | Other | Single-subject design (AB): therefore, each participant goes through two phases:
A= use regular prosthesis B= use 3D-printed prosthesis Receives: Device: 3D printed prosthetic sockets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test (TUG)
Participants rise from a chair, walk three meters, turn around a cone, return to the chair, and sit; time is recorded from start (standing) to finish (sitting). The TUG score is the average of two timed trials.
Measured: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Secondary outcomes (3)
Four Square Step Test (FSST)
Multi-directional stepping through four square positions (sequence: 1→2→3→4→1→4→3→2→1); time is recorded from initial stance in square one until returning to square one. The FSST score is the average of two timed trials.
Measured: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Activities-Specific Balance Confidence Scale (ABC)
A 16-item questionnaire that assesses confidence in avoiding balance loss across daily activities (e.g., walking on an icy sidewalk). Scores range from 0%-100%, with higher scores indicating greater confidence. The ABC score is the average of the 16 items.
Measured: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Socket comfort was measured with the Socket Comfort Score (SCS)
A single-item measure adapted from pain scales in which 0 = extreme discomfort and 10 = optimal comfort.
Measured: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start17 Jul 2023
- Primary completion24 Jan 2025
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputeesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject design (AB): therefore, each participant goes through two phases: A= use regular prosthesis B= use 3D-printed prosthesis
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C. Miller, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329738
- Sponsor's protocol ID
- H22-03708
- Other IDs
- F22-05611, F24-00369
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3D-Printed Prosthesis Portable Station: The Vancouver Limbkit Project
- ClinicalTrials.gov ID
- NCT07329738
- Acronym / sponsor ID
- H22-03708
- Conditions
- Transtibial Amputees
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 9 Jan 2026 (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 goal of this single-subject research design (clinical trial) is to assess the functionality of the 3D printed prostheses and to compare them to the existing prostheses in terms of mobility, balance, utility, and comfort. Participants who have a unilateral or bilateral transtibial amputation wear their existing prosthesis for roughly 3 weeks, followed by 3 weeks wearing a 3D printed prosthesis. The research assistants collect data throughout each period remotely, with the exception of one in-person visit to participants' homes to prepare the setting for the virtual evaluation sessions.
Detailed description
Once a participant is recruited and consent is obtained, Phase (A) begins with the research assistants conducting one home visit with the participant. This visit sets up the performance-based outcome measures, provides instructions for performing the tests, explains how to complete the online surveys, and clarifies how to take the video recordings. The research assistants distribute the Sociodemographic and Clinical Characteristics questionnaire to the participant via the UBC Qualtrics platform.
During Phase (A), the participant wears their definitive prosthesis and is remotely evaluated up to three times per week for three weeks. At the end of Phase (A), the participant receives an online self-reported survey to measure the utility of using the definitive prosthesis.
The participant then attends their prosthetic clinic to have measurements and a scan of their residual limb taken for the 3D printed prosthesis. The prosthetists use the "Comb" mobile scanner application, and the scans of the participants are securely stored and de-identified to maintain the confidentiality of the participants' information through the HIPAA-compliant Comb portal. The research assistant prints the prosthesis, which includes implanting a thermal sensor into the prosthesis to monitor the wear time. The participant visits the prosthetic clinic a second time to have the 3D printed prosthesis fitted by the relevant prosthetist in the team. The prosthetist ensures the new prosthesis is properly fitted and appropriate for use before allowing the participant to go home with it.
In Phase (B), the participant uses the 3D-printed prosthesis for three weeks and conducts the same outcome measures. At the end of Phase (B), the participant receives an online self-reported survey to measure the utility of using the 3D printed prosthesis.
Participants drop off the 3D-printed prostheses at their prosthetic clinics at the end of the study. Then the RA collects all the 3D printed prostheses to keep them in a locked cabinet in the principal investigator's office at the University of British Columbia.
The participant then has a one-to-one virtual semi-structured interview to explore their experiences with the 3D printed prosthesis.
A separate focus group is conducted with prosthetists involved in this study to obtain their feedback and suggestions regarding the Limbkit.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject design (AB): therefore, each participant goes through two phases: A= use regular prosthesis B= use 3D-printed prosthesis
| Arm | Type | Receives |
|---|---|---|
| Single group (one arm only) | Other | Device: 3D printed prosthetic socketsSingle-subject design (AB): therefore, each participant goes through two phases: A= use regular prosthesis B= use 3D-printed prosthesis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are adults 19+ years,
- have a unilateral or bilateral transtibial amputation,
- have an existing definitive prosthesis,
- use their definitive prosthesis two or more consecutive hours per day,
- have no wounds on the residual limb.
Key exclusion criteria (3 listed)
- are unable to adequately complete self-report measures or communicate well enough to participate in the end of project interview,
- have bilateral upper extremity amputations,
- have poorly controlled comorbidities (e.g., unstable diabetes, advanced heart problems)
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 |
|---|---|---|
| 3D printed prosthetic socketsThe sockets are 3D printed using Polyethylene Terephthalate Glycol (PETG) filament. The printer used for this process is the Fused Deposition Modelling (Creality Ender 6), equipped with a 1.0 mm nozzle diameter, a print speed of 45mm/s, and a layer thickness of 2 mm. To enhance their strength, the sockets are reinforced with Delta-Lite® plus cast tapes and assembled using a distal push-lock mechanism and plate. The number of reinforcement wraps of the Delta-Lite® differs for each region of the socket. Below the sockets, the same prosthetic components from the previous prosthesis are utilized where possible. Participants wear their 3D printed sockets for an adjustment period (3-7 days) and then come in for a follow-up session to ensure the 3D socket still fits well after their limb has settled into the new system. Once both the prosthetist and participant are happy with the fit, Phase B testing is scheduled. | Device | Single group (one arm only) |
Primary outcome
Timed Up and Go Test (TUG)
Time frame: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Participants rise from a chair, walk three meters, turn around a cone, return to the chair, and sit; time is recorded from start (standing) to finish (sitting). The TUG score is the average of two timed trials.
3 secondary outcomes
Four Square Step Test (FSST)
Time frame: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Activities-Specific Balance Confidence Scale (ABC)
Time frame: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Socket comfort was measured with the Socket Comfort Score (SCS)
Time frame: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Transtibial Amputees
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Recruiting
Reliability and Validity of Continuous Inter-limb Stability
Amputation, Lower Limb
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
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.
William C. Miller principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed prosthetic sockets in people with Transtibial Amputees, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Timed Up and Go Test (TUG) (time frame: Measurements are collected three times a week for three weeks (nine times) in phase A and three times a week for three weeks (nine times) in phase B.). 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 9 Jan 2026.