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

Last updated: August 6, 2025
Sponsor: Össur Iceland ehf
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Vacuum suspension system active or inactive

Clinical Study ID

NCT04804150
2020-A01309-30
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 suspensionsystem.

  • Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspensionsystem

  • 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

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Vacuum suspension system active or inactive
Phase:
Study Start date:
September 11, 2020
Estimated Completion Date:
July 10, 2023

Connect with a study center

  • Clinique de Provence-Bourbonne

    Aubagne, 13400
    France

    Site Not Available

  • La Tour de Gassie

    Bruges, 33523
    France

    Site Not Available

  • Chu Clermont Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

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