Lower Limb Amputation at Ankle (Injury)Phase 4PROPRIO-FOOTNCT02501408
Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees
A Phase 4 study testing propriofoot prosthesis in people with Lower Limb Amputation at Ankle (Injury), run by University Hospital, Angers at 1 site in France.
Trial summary
Evaluate a new porosthetic device in lower limb amputees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation at Ankle (Injury)
- What is being tested?
- propriofoot prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2015to 12 Apr 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Tibial amputation
- Ability top walk on treadmill
- Stable prosthesis for at least 3 months
Who cannot join
- Bilateral amputation
- Cancer
- Absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux
Evaluate a new porosthetic device in lower limb amputees.
Read the detailed description
Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.
- Conditions
- Lower Limb Amputation at Ankle (Injury)
- Being tested
- propriofoot prosthesis
- 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.
propriofoot prosthesisDevice
Adaptation of the device and evaluation after 1 month at home using the studied device
| Study group | Role | What they receive |
|---|---|---|
| Propriofoot prosthesis | Experimental | New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month Receives: Device: propriofoot prosthesis |
| Control | No intervention | Usual prosthesis is worn for 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption
Measurement on treadmill
Measured: 1 mois after adpatation of the selected device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start9 Mar 2015
- Primary completionFeb 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation at Ankle (Injury)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Abraham, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501408
- Sponsor's protocol ID
- 2014-A00374-43
- Acronym
- PROPRIO-FOOT
- Status last verified
- Dec 2016
- First submitted
- 16 Jul 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux
- ClinicalTrials.gov ID
- NCT02501408
- Acronym / sponsor ID
- PROPRIO-FOOT / 2014-A00374-43
- Conditions
- Lower Limb Amputation at Ankle (Injury)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 17 Jul 2015 (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.
Evaluate a new porosthetic device in lower limb amputees.
Detailed description
Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propriofoot prosthesis | Experimental | Device: propriofoot prosthesisNew propriofoot prosthesis is worn instead of usual prosthesis foer 1 month |
| Control | No intervention | –Usual prosthesis is worn for 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tibial amputation
- Ability top walk on treadmill
- Stable prosthesis for at least 3 months
Key exclusion criteria (3 listed)
- Bilateral amputation
- Cancer
- Absence of consent
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 |
|---|---|---|
| propriofoot prosthesisAdaptation of the device and evaluation after 1 month at home using the studied device | Device | Propriofoot prosthesis |
Primary outcome
oxygen consumption
Time frame: 1 mois after adpatation of the selected device
Measurement on treadmill
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 1 Nov 2017.
Related trials for Lower Limb Amputation at Ankle (Injury)
Recruiting
Prosthetic Performance Enhancement Trial
Amputation, Lower Limb Amputation Below Knee (Injury)
Active, not recruiting
VR to Evaluate Phantom Limb Pain
Phantom Limb Pain, Phantom Pain
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.
Pierre Abraham principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propriofoot prosthesis in people with Lower Limb Amputation at Ankle (Injury), run by University Hospital, Angers at 1 site in France.
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: finished, as of the sponsor's last update on 1 Nov 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 France. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
oxygen consumption (time frame: 1 mois after adpatation of the selected device). 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 1 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.