AmputationNCT04804150
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
A study testing Vacuum suspension system active or inactive in people with Amputation, run by Össur Iceland ehf at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Vacuum suspension system active or inactive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Sep 2020to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique de Provence-Bourbonne
Aubagne, 13400
La Tour de Gassie
Bruges, 33523
Chu Clermont Ferrand
Clermont-Ferrand, 63000
About this study
Official title: 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.
- Conditions
- Amputation
- Being tested
- Vacuum suspension system active or inactive
- Keywords
- Amputation, Elevated vacuum, Prosthetic suspension system, Vacuum-assisted suspension, N-of-1 Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum suspension system active or inactiveDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vacuum suspension system active or inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 50 days
Secondary outcomes (8)
Change in daily wearing time of the prosthesis
Declarative, in hours
Measured: Every day during 50 days
Change in the daily number of steps
Measured with a pedometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start11 Sep 2020
- Primary completion26 May 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- REMI KLOTZ, MD, Principal investigator, LA TOUR DE GASSIES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804150
- Sponsor's protocol ID
- 2020-A01309-30
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37452356
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial
- ClinicalTrials.gov ID
- NCT04804150
- Acronym / sponsor ID
- 2020-A01309-30
- Conditions
- Amputation
- Keywords
- Amputation, Elevated vacuum, Prosthetic suspension system, Vacuum-assisted suspension, N-of-1 Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
| Arm | Type | Receives |
|---|---|---|
| Medical Device active or inactive | Experimental | Device: Vacuum suspension system active or inactiveThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum suspension system active or inactiveThe 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 | Device | Medical Device active or inactive |
Primary outcome
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]
8 secondary outcomes
Change in daily wearing time of the prosthesis
Time frame: Every day during 50 days
Change in the daily number of steps
Time frame: Every day during 50 days
Assessment of the stump volume variation
Time frame: Every day during 50 days
Assessment of limb-prosthesis coaptation
Time frame: Every day during 50 days
Change L-Test of Functional Mobility
Time frame: Up to 50 days
Change in 6 Minute Walk Test (6MWT)
Time frame: Up to 50 days
Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: Up to 50 days
Change in confidence in maintaining balance while doing daily activities
Time frame: Up to 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 37452356Klotz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REMI KLOTZ, MD principal investigator
LA TOUR DE GASSIES
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum suspension system active or inactive in people with Amputation, run by Össur Iceland ehf at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confort change assessment (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.