Lower Limb Amputation Below Knee (Injury)CADNCT02124915
Influence of Socket Volume on Prosthesis Performance
An observational study of Lower Limb Amputation Below Knee (Injury), run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Transtibial amputees
Who may be able to join
- transtibial amputee
- at least 18 months post amputation
- over 18 years of age
- capable of treadmill walking and 90 seconds of continuous standing
Who cannot join
- skin breakdown on the residual limb
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.
- Keywords
- prosthetic socket, amputee
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transtibial amputees | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual limb fluid volume
Measured: 1 month
Secondary outcomes (1)
Activity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Joan Sanders, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124915
- Sponsor's protocol ID
- STUDY00001507
- Other IDs
- R01HD069387
- Acronym
- CAD
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2014
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Socket Volume on Prosthesis Performance
- ClinicalTrials.gov ID
- NCT02124915
- Acronym / sponsor ID
- CAD / STUDY00001507
- Keywords
- prosthetic socket, amputee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Apr 2014 (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.
The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transtibial amputees | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transtibial amputees
Key inclusion criteria (4 listed)
- transtibial amputee
- at least 18 months post amputation
- over 18 years of age
- capable of treadmill walking and 90 seconds of continuous standing
Key exclusion criteria (1 listed)
- skin breakdown on the residual limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Residual limb fluid volume
Time frame: 1 month
1 secondary outcome
Activity
Time frame: 1 month
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 24 Aug 2017.
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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 Lower Limb Amputation Below Knee (Injury), 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 4 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 24 Aug 2017. 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?
Residual limb fluid volume (time frame: 1 month). 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 24 Aug 2017.