Status:
COMPLETED
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
Lead Sponsor:
Össur Iceland ehf
Collaborating Sponsors:
Clin-Experts
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04804150
Start Date
September 11 2020
End Date
July 10 2023
Last Update
August 11 2025
Active Locations (3)
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1
Clinique de Provence-Bourbonne
Aubagne, France, 13400
2
La Tour de Gassie
Bruges, France, 33523
3
Chu Clermont Ferrand
Clermont-Ferrand, France, 63000