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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2023-07-10

Brief Summary

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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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Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The medical device will be active (plugged) or inactive (unplugged), but the patient nor the investigator won't know if the medical device is active(plugged) or inactive (unplugged).

After one-month accommodation period, patient will be randomly distributed into active or inactive vacuum 7 to 28 days phases with at least three phase change and a maximum of 50 days. The randomization will use a phase length ABAB randomization rather than block randomization commonly used in drug trials. However, because the patient has to come to the rehabilitation center at each phase change which would not allow the patient and the assessors to be blind to the next phase content, phases of a duration \>14, will be further randomized into two half-phases of the same content with a placebo visit between the two half-phases, in order to keep the blinding. All sequences containing 3 true transition of activation/inactivation of the medical device and up to 3 placebo transitions

Study Groups

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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

Group Type EXPERIMENTAL

Vacuum suspension system active or inactive

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No