Unilateral Trans Tibial AmputationPhase 1/2NCT01004926
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
A Phase 1/2 study testing Echelon foot in people with Unilateral Trans Tibial Amputation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Unilateral Trans Tibial Amputation
- What is being tested?
- Echelon foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 1/2
- 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 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ten individuals with a unilateral trans tibial amputation due to trauma.
- Walking at list one year from the end of their gait training. Mobility status is 3 or 4.
Who cannot join
- Bilateral amputation.
- Injury of the sound limb that compromises the gait of the amputee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.
Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.
- Conditions
- Unilateral Trans Tibial Amputation
- Being tested
- Echelon foot
- Keywords
- Unilateral trans-tibial amputees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echelon footDevice
One Echelon foot for each subject, for a period of a month.
| Study group | Role | What they receive |
|---|---|---|
| Echelon | Experimental | Not described Receives: Device: Echelon foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
Measured: Beginning of the trial and one month after
Secondary outcomes (1)
Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.
Measured: At the beginning of the trial and one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Trans Tibial AmputationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Itzhak Siev-Ner, Sheba Medical Center
- Investigators
- Itzhak Siev- Ner, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004926
- Sponsor's protocol ID
- SHEBA-09-7325-IS-CTIL
- Status last verified
- Apr 2016
- First submitted
- 19 Oct 2009
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
- ClinicalTrials.gov ID
- NCT01004926
- Acronym / sponsor ID
- SHEBA-09-7325-IS-CTIL
- Conditions
- Unilateral Trans Tibial Amputation
- Keywords
- Unilateral trans-tibial amputees
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Oct 2009 (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 aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.
Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echelon | Experimental | Device: Echelon foot |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ten individuals with a unilateral trans tibial amputation due to trauma.
- Walking at list one year from the end of their gait training. Mobility status is 3 or 4.
Key exclusion criteria (2 listed)
- Bilateral amputation.
- Injury of the sound limb that compromises the gait of the amputee.
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 |
|---|---|---|
| Echelon footOne Echelon foot for each subject, for a period of a month. | Device | Echelon |
Primary outcome
While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
Time frame: Beginning of the trial and one month after
1 secondary outcome
Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.
Time frame: At the beginning of the trial and one month later
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 15 Apr 2016.
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.
Itzhak Siev- Ner, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Echelon foot in people with Unilateral Trans Tibial Amputation, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 15 Apr 2016. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform. (time frame: Beginning of the trial and one month after). 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 15 Apr 2016.