Access Socket: a flexible prosthetic socket for transtibial amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label, two-arm crossover study compares the Access Socket, which combines rigid carbon-fiber support with flexible urethane-resin zones, to the standard rigid socket in adults with transtibial amputation. Both sockets use identical plaster molds to ensure the same internal geometry, with the only difference being material structure. Participants will experience both socket types in a crossover design to directly compare comfort, mobility, and perceived function. The study aims to determine if the AS provides better pressure distribution and ambulation without compromising mechanical stability.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital National d'Instruction des Armées (HNIA) Percy
  Clamart, France Recruiting
• Hôpital Filieris de Freyming-Merlebach
  Freyming-Merlebach, France Recruiting
• CHU Grenoble Alpes - Hôpital Sud
  Grenoble, France Recruiting
• Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur
  Nancy, France Recruiting
• Insititution Nationale des Invalides
  Paris, France Recruiting

Study contacts

• Principal investigator: Isabelle Loiret, MD — Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France
• Study coordinator: Isabelle Loiret, MD
• Email: isabelle.loiretpro@gmail.com
• Phone: +33383529950

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Suralis vibrotactile system for phantom limb pain after lower-limb amputation

  This pilot will test whether wearing the Suralis vibration feedback system during walking reduces phantom limb pain in people with a unilateral lower-limb amputation.

  Recruiting Median · Wiesbaden, Hesse · NCT07324109

• E-SWEAT wearable sensors to monitor residual limb health

  This trial tests a wearable sensor system that measures pressure, temperature, and lactic acid in sweat inside prosthetic sockets for adults with below-knee (transtibial) amputations.

  Recruiting Phase 1 North Carolina State University · Raleigh, North Carolina · NCT07216183

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• Improving prosthetic socket fit for veterans with lower limb amputations

  This study is testing whether an adjustable prosthetic socket can help veterans with lower limb amputations walk better and feel more comfortable compared to a regular socket.

  Recruiting VA Office of Research and Development · Aurora, Colorado · NCT05989243

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.