Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System (NCT04804150) | Clinical Trial Compass
CompletedNot Applicable
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
France20 participantsStarted 2020-09-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.