NCT07214493 Study on a Prosthetic Foot With Adjustable Heel Height
| NCT ID | NCT07214493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Otto Bock France SNC |
| Condition | Lower Limb Amputation Above Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2026-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-08 with a primary completion date of 2026-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an important aspect of coping with a physical disability. The Taleo Adjust is a prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn. This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.
Eligibility Criteria
Inclusion Criteria : * Adult patient with a major lower limb amputation whose life project includes: * movement in buildings other than the home (ICF d4601), * movement outside the home and other buildings (ICF d4602), * and other specified activities related to movement in other various places (ICF d4608). * Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months * Patient who wishes to walk with shoes with different heel heights, and/or barefoot Exclusion Criteria: * Patient with a high impact level (e.g.: sport) * Patient with hip disarticulation or equivalent * Patient with an unstabilised residual limb and/or an unsuitable socket * Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required foot size \<22 or \>28; mounting height less than 118 mm) * Patient whose usual foot has a heel height adjustment system * Patient unavailable for the duration of the study and/or unable to understand the instructions and/or answer questionnaires in French * Patient already participating in another study * Patient in an emergency situation or pregnant woman
Contact & Investigator
Brice LAVRARD, Dr.
STUDY CHAIR
Institut Merle d'Aubigné - VALENTON
Frequently Asked Questions
Who can join the NCT07214493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Limb Amputation Above Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07214493 currently recruiting?
Yes, NCT07214493 is actively recruiting participants. Contact the research team at aurelie.lacroix@ottobock.com for enrollment information.
Where is the NCT07214493 trial being conducted?
This trial is being conducted at Concarneau, France, Échirolles, France, Nancy, France, Saint-Herblain, France and 1 additional location.
Who is sponsoring the NCT07214493 clinical trial?
NCT07214493 is sponsored by Otto Bock France SNC. The principal investigator is Brice LAVRARD, Dr. at Institut Merle d'Aubigné - VALENTON. The trial plans to enroll 30 participants.