People With Lower Limb Amputation That Are AmbulatoryNCT01245504
Assessment of Socket Shapes Made by Central Fabrication Facilities
An observational study of People With Lower Limb Amputation That Are Ambulatory, run by University of Washington at 1 site in United States.
Trial summary
Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- People With Lower Limb Amputation That Are Ambulatory
- What is being tested?
- Assessed for socket fit
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2011
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: people with lower limb amputation that are ambulatory
Who may be able to join
- trans-tibial amputees who use a prosthesis and are ambulatory
Who cannot join
- do not have a prosthesis, cannot ambulate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Bioengineering Department
Seattle, Washington, 98195
About this study
Official title: Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.
Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.
- Being tested
- Assessed for socket fit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessed for socket fitOther
Subjects are clinically assessed during standing to see how well computer manufactured sockets fit
| Study group | Role | What they receive |
|---|---|---|
| Lower-limb amputee | Subjects with at least one lower limb amputated at teh trans-tibial level Receives: Other: Assessed for socket fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb volume
Measured: 1 day
Secondary outcomes (1)
Limb shape
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Lower Limb Amputation That Are AmbulatoryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sanders, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245504
- Sponsor's protocol ID
- 31673 E/B
- Status last verified
- Apr 2014
- First submitted
- 18 Nov 2010
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
- ClinicalTrials.gov ID
- NCT01245504
- Acronym / sponsor ID
- 31673 E/B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Nov 2010 (estimated)
- 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.
Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.
Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower-limb amputee | – | Other: Assessed for socket fitSubjects with at least one lower limb amputated at teh trans-tibial level |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people with lower limb amputation that are ambulatory
Key inclusion criteria (1 listed)
- trans-tibial amputees who use a prosthesis and are ambulatory
Key exclusion criteria (1 listed)
- do not have a prosthesis, cannot ambulate
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 |
|---|---|---|
| Assessed for socket fitSubjects are clinically assessed during standing to see how well computer manufactured sockets fit | Other | Lower-limb amputee |
Primary outcome
Limb volume
Time frame: 1 day
1 secondary outcome
Limb shape
Time frame: 1 day
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 25 Apr 2014.
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 People With Lower Limb Amputation That Are Ambulatory, run by University of Washington 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 1 inclusion and 1 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 25 Apr 2014. 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?
Limb volume (time frame: 1 day). 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 25 Apr 2014.