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

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

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Vacuum suspension system active or inactive

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aubagne, France, 13400
    • Clinique de Provence-Bourbonne
  • Bruges, France, 33523
    • La Tour de Gassie
  • Clermont-Ferrand, France, 63000
    • Chu Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Device active or inactive; The medical device will be active, or inactive. Randomization will define when and how long time the medical device will plugged and active, and when and how long time the medical device will be unplugged and inactive. The patient won't know if the medical device is active or not	Device: Vacuum suspension system active or inactive; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confort change assessment	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]	50 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily wearing time of the prosthesis	Declarative, in hours	Every day during 50 days
Change in the daily number of steps	Measured with a pedometer	Every day during 50 days
Assessment of the stump volume variation	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	Every day during 50 days
Assessment of limb-prosthesis coaptation	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	Every day during 50 days
Change L-Test of Functional Mobility	The L Test is a timed ambulation over 20 meters, which includes two sit to/from stand transfers and three turns	Up to 50 days
Change in 6 Minute Walk Test (6MWT)	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	Up to 50 days
Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology	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	Up to 50 days
Change in confidence in maintaining balance while doing daily activities	Measured by the simplified Activities-specific Balance Confidence Scale (ABC-S)	Up to 50 days

Collaborators and Investigators

• Sponsor: Össur Iceland ehf
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: REMI KLOTZ, MD, LA TOUR DE GASSIES

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Amputation; Elevated vacuum; Prosthetic suspension system; Vacuum-assisted suspension; N-of-1 Trial
• Other Study ID Numbers: 2020-A01309-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No