NCT04791163

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

March 8, 2021

Last Update Submit

August 8, 2022

Conditions

Lower Limb Amputation Above Knee (Injury)

Outcome Measures

Primary Outcomes (1)

  • Comfort evaluation

    Socket Comfort Score (SCS)

    1 minute

Secondary Outcomes (2)

  • Comfort evaluation in various situations

    1 minute

  • Locomotor capability

    5 minutes

Study Arms (2)

Sub-ischial socket

EXPERIMENTAL

Start using the sub-ischial socket for four weeks and be tested with this socket.

Device: Socket evaluation

Ischial containment socket

ACTIVE COMPARATOR

Start using the ischial containment socket for four weeks and be tested with this socket.

Device: Socket evaluation

Interventions

Socket evaluationDEVICE

The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Ischial containment socketSub-ischial socket

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • unilaterla or bilateral amputee
  • able to done the socket standing
  • whatever the etiology

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Les Capucins

Angers, 49100, France

Location

UGECAM La Tour de Gassies

Bruges, 33523, France

Location

Clinique du Cabirol

Colomiers, 31771, France

Location

Hôpital Léon Bérard

Hyères, 83418, France

Location

UGECAM - IRR Nancy

Nancy, 54000, France

Location

Institution Nationale des Invalides

Paris, 75007, France

Location

Centre Mutualiste de Kerpape

Ploemeur, 56275, France

Location

UGECAM La Tourmaline

Saint-Herblain, 44818, France

Location

CHBA Vannes

Vannes, 56000, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

April 15, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)