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

NCT04804150 | Completed

• 1 other identifier: 2020-A01309-30
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Amputation; Elevated vacuum; Prosthetic suspension system; Vacuum-assisted suspension; N-of-1 Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in daily wearing time of the prosthesis

  Every day during 50 days

• Change in the daily number of steps

  Every day during 50 days

• Assessment of the stump volume variation

  Every day during 50 days

• Assessment of limb-prosthesis coaptation

  Every day during 50 days

• Change L-Test of Functional Mobility

  Up to 50 days

Study Arms (1)

Medical Device active or inactive

EXPERIMENTAL

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

Interventions

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

Medical Device active or inactive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Clin-Experts: collaborator

Study Sites (3)

Clinique de Provence-Bourbonne

Aubagne, 13400, France

Location

La Tour de Gassie

Bruges, 33523, France

Location

Chu Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

• Klotz R, Emile G, Daviet JC, De Seze M, Godet J, Urbinelli R, Krasny-Pacini A. Daily socket comfort in transtibial amputee with a vacuum-assisted suspension system: study protocol of a randomized, multicenter, double-blind multiple N-of-1 trial. BMC Sports Sci Med Rehabil. 2023 Jul 14;15(1):85. doi: 10.1186/s13102-023-00694-4.

  PMID: 37452356 DERIVED

Study Officials

• REMI KLOTZ, MD

  LA TOUR DE GASSIES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 18, 2021
• Study Start: September 11, 2020
• Primary Completion: May 26, 2023
• Study Completion: July 10, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

FR (3)