AmputationDEFINCT06627361
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
A study testing PRO-FLEX PIVOT Foot evaluation and Class III ESAR Foot evaluation in people with Amputation, run by Össur Iceland ehf at 1 site in France.
Trial summary
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- PRO-FLEX PIVOT Foot evaluation and Class III ESAR Foot evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2023to 16 May 2025
- Phase
- Interventional
- 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
- Adult patient (over 18 years of age)
- Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
- Regularly using (more than 8 hours/day) a class III ESAR foot
- Functional class (CNEDiMTS indication)1
- Insured person.
- Able to answer questionnaires.
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- Providing informed and written consent to participate in the study.
- Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
- Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)
Who cannot join
- Bilateral lower limb amputation
- Femoral amputation
- Wearing a temporary prosthesis
- Change of socket or suspension system planned during the study.
- Change of any functional component as torsion or choc adapter
- Significant change in the patient's routine activities expected during the study.
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- Progressive associated pathology that may prevent patient follow-up.
- Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
- No osteointegration patients
- Lack of consent
- Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
- Person not affiliated with or a beneficiary of a health insurance plan.
- Patient unable to understand the study instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentric, Comparative, Randomized, Cross-over Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
- The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
- The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
- An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
- Conditions
- Amputation
- Being tested
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Keywords
- Lower limb amputation, Mobility, Pro-Flex Pivot, Randomized, ESAR foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-FLEX PIVOT Foot evaluationDevice
The subject will wear the PRO-FLEX PIVOT foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test
Class III ESAR Foot evaluationDevice
The subject will wear his usual Class III ESAR Foot foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test
| Study group | Role | What they receive |
|---|---|---|
| PRO-FLEX PIVOT | Experimental | The patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days Receives: Device: PRO-FLEX PIVOT Foot evaluation |
| Class III ESAR foot | Active comparator | The patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days Receives: Device: Class III ESAR Foot evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mobility of the patient
Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-M™) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility)
Measured: 28 days
Secondary outcomes (5)
Variations in comfort experienced during the wearing of the foot
Evaluate the impact of the foot on the comfort experienced by the patient with visual analog scale (VAS) from 0 (= not at all comfortable) to 5 (=Very comfortable)
Measured: 28 days
Change in quality of life
Evaluate the impact of the foot on the quality of life assessed by the Orthotics Prosthetics Users Survey (OPUS) patient Self report questionnaire. The higher the score [0-92], the better the perception of quality of life.
Measured: 28 days
Change in satisfaction of the patient
Assess the change in patient satisfaction with Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); Higher scores indicate greater satisfaction.
Measured: 28 days
Occurence of falls
Measured: 28 days
Number of patients with technical incidents
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start22 Nov 2023
- Primary completion16 May 2025
- Study completion16 May 2025
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Noël MARTINET, PhD, Principal investigator, IRR - Établissement de Nancy - Louis-Pierquin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627361
- Sponsor's protocol ID
- 2023-A01374-41
- Acronym
- DEFI
- Status last verified
- May 2026
- First submitted
- 30 Sep 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Comparative, Randomized, Cross-over Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot
- ClinicalTrials.gov ID
- NCT06627361
- Acronym / sponsor ID
- DEFI / 2023-A01374-41
- Conditions
- Amputation
- Keywords
- Lower limb amputation, Mobility, Pro-Flex Pivot, Randomized, ESAR foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 4 Oct 2024 (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.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
- The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
- The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
- An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO-FLEX PIVOT | Experimental | Device: PRO-FLEX PIVOT Foot evaluationThe patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days |
| Class III ESAR foot | Active comparator | Device: Class III ESAR Foot evaluationThe patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient (over 18 years of age)
- Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
- Regularly using (more than 8 hours/day) a class III ESAR foot
- Functional class (CNEDiMTS indication)1
- Insured person.
Key exclusion criteria (13 listed)
- Bilateral lower limb amputation
- Femoral amputation
- Wearing a temporary prosthesis
- Change of socket or suspension system planned during the study.
- Change of any functional component as torsion or choc adapter
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 |
|---|---|---|
| PRO-FLEX PIVOT Foot evaluationThe subject will wear the PRO-FLEX PIVOT foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test | Device | PRO-FLEX PIVOT |
| Class III ESAR Foot evaluationThe subject will wear his usual Class III ESAR Foot foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test | Device | Class III ESAR foot |
Primary outcome
Change of mobility of the patient
Time frame: 28 days
Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-M™) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility)
5 secondary outcomes
Variations in comfort experienced during the wearing of the foot
Time frame: 28 days
Change in quality of life
Time frame: 28 days
Change in satisfaction of the patient
Time frame: 28 days
Occurence of falls
Time frame: 28 days
Number of patients with technical incidents
Time frame: 28 days
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 22 May 2026.
- 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.
Noël MARTINET, PhD principal investigator
IRR - Établissement de Nancy - Louis-Pierquin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO-FLEX PIVOT Foot evaluation and Class III ESAR Foot evaluation in people with Amputation, run by Össur Iceland ehf 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 9 inclusion and 13 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 22 May 2026. 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.
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?
Change of mobility of the patient (time frame: 28 days). 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 22 May 2026.