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

NCT04804150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-11

No results posted yet for this 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.

Conditions

  • Amputation

Interventions

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

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • REMI KLOTZ, MD · LA TOUR DE GASSIES

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2023-05-26
Completion
2023-07-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804150 on ClinicalTrials.gov