Actively Recruiting
Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
Led by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Updated on 2026-05-18
25
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Lead Sponsor
I
Institution Nationale des Invalides
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new type of prosthetic socket called the Access Socket (AS) for adults with transtibial amputation, which affects the lower leg below the knee. This study compares the AS to the standard rigid socket (RS) to see if it improves comfort, function, and mobility. The AS combines rigid carbon-fiber areas with flexible urethane-resin zones to enhance comfort and pressure distribution while maintaining support for walking. This study is a multicenter, randomized, open-label crossover trial involving 25 adults. Participants will wear each type of socket for about 4 weeks, after a 1-2 week adaptation period, in a randomized order. One group starts with the RS and then switches to the AS, while the other group starts with the AS and then switches to the RS. Both sockets are made from the same mold to ensure the same internal shape; the difference lies in the materials used. The study includes an optional follow-up visit one month after the second socket period for those who choose to keep the AS. During the study, participants will attend four visits over approximately 14 to 21 weeks. Researchers will assess function using the Patient Specific Functional Scale (PSFS) at the end of each socket wear period. Other measures include comfort, satisfaction, psychosocial adjustment, mobility, and prosthesis utility. Safety and patient choice of socket at study completion will also be monitored. Participants must be adults with transtibial amputation currently using a rigid socket and able to provide informed consent.
CONDITIONS
Brief Title
Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral or bilateral transtibial amputation
- Currently fitted with a definitive carbon rigid socket
- Any residual-limb shape
- Any cause of amputation
- Able to understand simple instructions, read, write, and provide informed consent, or accompanied by a trusted person if unable to read/write
- Provided free written informed consent
- Aged 18 years or older
- Affiliated to a social security system
You will not qualify if you...
- Use of hydroalcoholic solution for socket donning
- Currently fitted with a provisional socket
- Neurological condition limiting activity participation
- Orthopedic condition limiting activity participation
- Pregnant or breastfeeding women
- Minors
- Persons unable to express consent or not under legal protection
- Persons under guardianship, curatorship, or judicial protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 to 12 weeks
Participants wear one type of prosthetic socket for 4 weeks, followed by a switch to the other socket type with 1 to 2 weeks of adaptation and another 4 weeks of wear.
3 visits: one at inclusion, one after the first socket period, and one after the second socket period
Duration - 1 month
Participants may have an optional follow-up visit one month later if they elect to keep the Access Socket.
1 optional visit (in-person)
Trial Site Locations
Total: 5 locations
1
Hôpital National d'Instruction des Armées (HNIA) Percy
Clamart, France, 92140
Actively Recruiting
2
Hôpital Filieris de Freyming-Merlebach
Freyming-Merlebach, France, 57804
Actively Recruiting
3
CHU Grenoble Alpes - Hôpital Sud
Grenoble, France, 38434
Actively Recruiting
4
Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur
Nancy, France, 54000
Actively Recruiting
5
Insititution Nationale des Invalides
Paris, France, 75007
Actively Recruiting
Research Team
I
Isabelle Loiret, MD
J
Jonathan Pierret, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here