NCT07592325 Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
| NCT ID | NCT07592325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est |
| Condition | Transtibial Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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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 25 participants in total. It began in 2026-04-27 with a primary completion date of 2027-04-27.
⚠ 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
Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation. The AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility. This multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.
Eligibility Criteria
Inclusion Criteria: * Unilateral or bilateral transtibial amputation * Currently fitted with a definitive carbon rigid socket * Any residual-limb shape * Any etiology * Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read/write autonomously * Provided free written informed consent * Aged 18 years or older * Affiliated to a social security system Exclusion Criteria: * Use of hydroalcoholic solution (HAS) for socket donning * Currently fitted with a provisional socket * Neurological pathology limiting capacity to participate in activities * Orthopedic pathology limiting capacity to participate in activities * Pregnant or breastfeeding women * Minors * Persons not under legal protection or unable to express consent * Persons under guardianship or curatorship * Persons under judicial protection
Contact & Investigator
Isabelle Loiret, MD
PRINCIPAL INVESTIGATOR
Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France
Frequently Asked Questions
Who can join the NCT07592325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transtibial Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07592325 currently recruiting?
Yes, NCT07592325 is actively recruiting participants. Contact the research team at isabelle.loiretpro@gmail.com for enrollment information.
Where is the NCT07592325 trial being conducted?
This trial is being conducted at Clamart, France, Freyming-Merlebach, France, Grenoble, France, Nancy, France and 1 additional location.
Who is sponsoring the NCT07592325 clinical trial?
NCT07592325 is sponsored by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est. The principal investigator is Isabelle Loiret, MD at Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France. The trial plans to enroll 25 participants.