AmputationNCT06762847
Development And Durability Of Prosthetic Liner For Transtibial Amputee
An observational study of Amputation, run by Superior University at 1 site in Pakistan.
Trial summary
About 16% of the world's population suffers from physical disabilities, of which about 65% of the population experience lower limb amputations, and in lower limb about 50% face transtibial amputation and use transtibial prosthesis. The transtibial prosthetic users face many stump-related problems. Read more about this study
- Who is it for?
- Ages 40 to 40 years
- Conditions the study is for
- Amputation
- What is being tested?
- Use of Conventional Silicone Prosthetic Liner
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Observational
- 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 40 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Transtibial amputee with medium stump, using the prosthetic leg for 3 years without prosthetic liners. age should be 40 years
Who may be able to join
- Transtibial amputee with medium stump.
- Amputee which has been using the prosthetic leg for 3 years without prosthetic liners.
- Amputee with 40 years of age.
Who cannot join
- Any other amputees except transtibial.
- Amputees without using prosthetic devices.
- Amputees above 40 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
About 16% of the world's population suffers from physical disabilities, of which about 65% of the population experience lower limb amputations, and in lower limb about 50% face transtibial amputation and use transtibial prosthesis. The transtibial prosthetic users face many stump-related problems.
Read the detailed description
As a physical interface, a prosthetic liner is commonly used as a transition material between residual limb and stiff socket to provide optimal comfort, fit, and functionality. By using a prosthetic liner, stump-related issues can be relieved, and long-term use of prosthetic devices achieved by an amputee. Prosthetic liners are so expensive due to being imported that patients can't afford them. My study aims to develop a low-cost prosthetic liner for transtibial amputees to ensure its availability and affordability for patients who need a prosthetic liner, by using material available at a local level like silicon to improve their ability to cushion and protect the residual limb from injuries induced by load-bearing normal and shear stresses. The study includes 1 sample size of 40 years of age males, Participents develop a prosthetic liner and then use it on these samples to determine liner durability and hope the results are in favor.
- Conditions
- Amputation
- Being tested
- Use of Conventional Silicone Prosthetic Liner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Conventional Silicone Prosthetic LinerDevice
At this stage participant who will be fitted with a standard silicone liner typically used for transtibial prosthetics. Over a set duration, we will assess the liner's performance, particularly in terms of durability, comfort, skin health, and fit stability. Acting as the control group, this cohort will provide essential baseline data for comparison with the innovative prosthetic liner.
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Not described Receives: Device: Use of Conventional Silicone Prosthetic Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket Comfort Score
The socket comfort score is a numerical rating scale used to assess the comfort of a prosthetic. the score ranges from 0 to 10, with 0 being the least comfortable and 10 being the most comfortable.
Measured: 12 Months
Timed Up and Go (TUG)
This test measures the Time in seconds; lower scores indicate better performance the lower the time is the better the score is.
Measured: 12 months
Skin Irritation Scale
Skin Irritation Scale deals with the skin irritation (Scores: 0-4, where 0 = no irritation and 4 = severe irritation)
Measured: 12 months
6-Minute Walk Test
6-Minute Walk Test in this test we mesuares the Distance in meters; higher distance indicates better performance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (estimated)
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.
- More trials run by Superior UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762847
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/757
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Durability Of Prosthetic Liner For Transtibial Amputee
- ClinicalTrials.gov ID
- NCT06762847
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/757
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
About 16% of the world's population suffers from physical disabilities, of which about 65% of the population experience lower limb amputations, and in lower limb about 50% face transtibial amputation and use transtibial prosthesis. The transtibial prosthetic users face many stump-related problems.
Detailed description
As a physical interface, a prosthetic liner is commonly used as a transition material between residual limb and stiff socket to provide optimal comfort, fit, and functionality. By using a prosthetic liner, stump-related issues can be relieved, and long-term use of prosthetic devices achieved by an amputee. Prosthetic liners are so expensive due to being imported that patients can't afford them. My study aims to develop a low-cost prosthetic liner for transtibial amputees to ensure its availability and affordability for patients who need a prosthetic liner, by using material available at a local level like silicon to improve their ability to cushion and protect the residual limb from injuries induced by load-bearing normal and shear stresses. The study includes 1 sample size of 40 years of age males, Participents develop a prosthetic liner and then use it on these samples to determine liner durability and hope the results are in favor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exp Group | – | Device: Use of Conventional Silicone Prosthetic Liner |
Who may qualify
- Ages
- 40 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Transtibial amputee with medium stump, using the prosthetic leg for 3 years without prosthetic liners. age should be 40 years
Key inclusion criteria (3 listed)
- Transtibial amputee with medium stump.
- Amputee which has been using the prosthetic leg for 3 years without prosthetic liners.
- Amputee with 40 years of age.
Key exclusion criteria (3 listed)
- Any other amputees except transtibial.
- Amputees without using prosthetic devices.
- Amputees above 40 years of age.
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 |
|---|---|---|
| Use of Conventional Silicone Prosthetic LinerAt this stage participant who will be fitted with a standard silicone liner typically used for transtibial prosthetics. Over a set duration, we will assess the liner's performance, particularly in terms of durability, comfort, skin health, and fit stability. Acting as the control group, this cohort will provide essential baseline data for comparison with the innovative prosthetic liner. | Device | Exp Group |
Primary outcome
Socket Comfort Score
Time frame: 12 Months
The socket comfort score is a numerical rating scale used to assess the comfort of a prosthetic. the score ranges from 0 to 10, with 0 being the least comfortable and 10 being the most comfortable.
Timed Up and Go (TUG)
Time frame: 12 months
This test measures the Time in seconds; lower scores indicate better performance the lower the time is the better the score is.
Skin Irritation Scale
Time frame: 12 months
Skin Irritation Scale deals with the skin irritation (Scores: 0-4, where 0 = no irritation and 4 = severe irritation)
6-Minute Walk Test
Time frame: 12 months
6-Minute Walk Test in this test we mesuares the Distance in meters; higher distance indicates better performance
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 8 Jan 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Amputation, run by Superior University at 1 site in Pakistan.
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 3 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 8 Jan 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 Pakistan. 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?
Socket Comfort Score (time frame: 12 Months). The study lists 4 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 8 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.