Lower Limb Amputation Above Knee (Injury)P20-EMBSUBINCT04791163
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
A study testing Socket evaluation in people with Lower Limb Amputation Above Knee (Injury), run by Proteor Group at 9 sites in France.
Trial summary
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- Socket evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Apr 2021to 1 Jul 2022
- 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
- can give informed consent
- aged 18 or more
- above-knee amputee, wearing a definitive ischial containment socket
- stump longer than 16cm
- wearing a liner, whatever the suspension system
- able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)
Show all 9Show fewer
- unilaterla or bilateral amputee
- able to done the socket standing
- whatever the etiology
Who cannot join
- protected person
- pregnant woman or nursing mother
- subject having comorbidities heavily impacting feeling or socket donning
- allergic to silicon
- suffering from big volume variations in a same day
- infecté stump (may lead to lymphatic problems)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Les Capucins
Angers, 49100
UGECAM La Tour de Gassies
Bruges, 33523
Clinique du Cabirol
Colomiers, 31771
Hôpital Léon Bérard
Hyères, 83418
UGECAM - IRR Nancy
Nancy, 54000
Institution Nationale des Invalides
Paris, 75007
Centre Mutualiste de Kerpape
Ploemeur, 56275
UGECAM La Tourmaline
Saint-Herblain, 44818
CHBA Vannes
Vannes, 56000
About this study
Official title: AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
Read the detailed description
Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.
- Being tested
- Socket evaluation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket evaluationDevice
The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test
| Study group | Role | What they receive |
|---|---|---|
| Sub-ischial socket | Experimental | Start using the sub-ischial socket for four weeks and be tested with this socket. Receives: Device: Socket evaluation |
| Ischial containment socket | Active comparator | Start using the ischial containment socket for four weeks and be tested with this socket. Receives: Device: Socket evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort evaluation
Socket Comfort Score (SCS)
Measured: 1 minute
Secondary outcomes (2)
Comfort evaluation in various situations
Same question for four detailed situations
Measured: 1 minute
Locomotor capability
PLUS-M questionnaire and 2-minute walking test
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Apr 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteor Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791163
- Sponsor's protocol ID
- 2020-A03303-36
- Acronym
- P20-EMBSUBI
- Status last verified
- Aug 2022
- First submitted
- 8 Mar 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT04791163
- Acronym / sponsor ID
- P20-EMBSUBI / 2020-A03303-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Proteor GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 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.
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
Detailed description
Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-ischial socket | Experimental | Device: Socket evaluationStart using the sub-ischial socket for four weeks and be tested with this socket. |
| Ischial containment socket | Active comparator | Device: Socket evaluationStart using the ischial containment socket for four weeks and be tested with this socket. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- can give informed consent
- aged 18 or more
- above-knee amputee, wearing a definitive ischial containment socket
- stump longer than 16cm
- wearing a liner, whatever the suspension system
Key exclusion criteria (6 listed)
- protected person
- pregnant woman or nursing mother
- subject having comorbidities heavily impacting feeling or socket donning
- allergic to silicon
- suffering from big volume variations in a same day
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 |
|---|---|---|
| Socket evaluationThe subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test | Device | Ischial containment socket, Sub-ischial socket |
Primary outcome
Comfort evaluation
Time frame: 1 minute
Socket Comfort Score (SCS)
2 secondary outcomes
Comfort evaluation in various situations
Time frame: 1 minute
Locomotor capability
Time frame: 5 minutes
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 9 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Lower Limb Amputation Above Knee (Injury)
Recruiting
Prosthetic Performance Enhancement Trial
Amputation, Lower Limb Amputation Below Knee (Injury)
Active, not recruitingObservational study
C-STAR Movement Database
Stroke, Parkinson Disease
Recruiting
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Amputation, Prosthesis User
Recruiting
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
Amputation, Amputation; Traumatic, Leg, Lower
RecruitingObservational study
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
Lower Limb Amputation Above Knee (Injury)
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket evaluation in people with Lower Limb Amputation Above Knee (Injury), run by Proteor Group at 9 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 9 inclusion and 6 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Comfort evaluation (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.