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Completed

NCT Number: NCT04804150

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

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.

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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de Provence-Bourbonne, Aubagne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vacuum suspension system active or inactive

Device

The device will be plugged in, or won't be plugged in, depending of the randomization. The patient and the investigator will not know whether the device is plugged in or not, and if the medical device is active or not

Primary outcomes

  1. Confort change assessment

    Time frame: 50 days

    Assess the impact of the vacuum suspension system on the fitting's comfort compared to the vacuum suspension system inactive system with a daily evaluation on Socket Comfort Score [Scale : On a 0 - 10 scale : 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit]

Secondary outcomes

  1. Change in daily wearing time of the prosthesis

    Time frame: Every day during 50 days

    Declarative, in hours

  2. Change in the daily number of steps

    Time frame: Every day during 50 days

    Measured with a pedometer

  3. Assessment of the stump volume variation

    Time frame: Every day during 50 days

    The stump volume variation will be assessed by 2 questions :

    How many times have you removed your prosthesis during the day (not counting the evening's removal) to add compensation sheaths? " 0, 1, 2, 3, 4, >4

    Did you have the fear at one (or more) moment(s) of the day, of losing your prosthesis, that it would come off by itself? " Visual Analogue Scale (VAS) of 0: no not at all at 10 = yes a lot

  4. Assessment of limb-prosthesis coaptation

    Time frame: Every day during 50 days

    The limp-prosthesis coaptation will be assessed by 2 questions :

    "Do you feel that you have mastered your prosthesis, that it is one with you?" VAS from 0 = not at all to 10 =perfectly

    "Do you feel a piston movement of your prosthesis when walking (sensation of vertical movement of the prosthesis in relation to the stump when walking)?" VAS from 0 = not at all to 10 = yes a lot

  5. Change L-Test of Functional Mobility

    Time frame: Up to 50 days

    The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns

  6. Change in 6 Minute Walk Test (6MWT)

    Time frame: Up to 50 days

    The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed

  7. Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

    Time frame: Up to 50 days

    Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction

  8. Change in confidence in maintaining balance while doing daily activities

    Time frame: Up to 50 days

    Measured by the simplified Activities-specific Balance Confidence Scale (ABC-S)

Sponsors and collaborators

Lead sponsor

Össur Iceland ehf

Industry

Collaborators

  • Clin-Experts

Registry information

Official study title

Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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