Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System

  • STATUS
    Recruiting
  • End date
    Mar 25, 2022
  • participants needed
    20
  • sponsor
    Össur Ehf
Updated on 25 March 2021

Summary

The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective, randomized, double-blind, multiple N-of-1 trial.

In order to assess the therapeutic effect of the vacuum suspension system, given the heterogeneity of the population and the small number of patients eligible for the study, the multiple N-of-1 trial seems to us to be the methodology. The principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator.

Details
Condition Amputation, Limb Preservation and Amputation
Treatment Vacuum suspension system active or inactive
Clinical Study IdentifierNCT04804150
SponsorÖssur Ehf
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female over 18 years of age
Unilateral transtibial amputation for more than 6 months
Equipped for more than 3 months with a Seal-in liner without the vacuum suspension system
Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspension system
Patient meeting the criteria of ICF(International Classification of Functioning, Disability and Health) classification d4602 and/or d4608
Presenting some discomfort in the socket evaluated by a SCS 7/10
Absence of severe comorbidity
Patient with a smartphone and a functional 4G connection

Exclusion Criteria

Cognitive impairment that does not allow instructions to be followed
Have already been equipped with the evaluated vacuum suspension system
Pregnant women
Patient subject to a legal protection measure
Patient not affiliated with social security
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note