NCT02501408

Brief Summary

Evaluate a new porosthetic device in lower limb amputees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 9, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

November 1, 2017

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

July 16, 2015

Last Update Submit

October 30, 2017

Conditions

Lower Limb Amputation at Ankle (Injury)

Outcome Measures

Primary Outcomes (1)

  • oxygen consumption

    Measurement on treadmill

    1 mois after adpatation of the selected device

Study Arms (2)

Propriofoot prosthesis

EXPERIMENTAL

New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month

Device: propriofoot prosthesis

Control

NO INTERVENTION

Usual prosthesis is worn for 1 month

Interventions

propriofoot prosthesisDEVICE

Adaptation of the device and evaluation after 1 month at home using the studied device

Propriofoot prosthesis

Eligibility Criteria

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

You may qualify if:

  • Tibial amputation
  • Ability top walk on treadmill
  • Stable prosthesis for at least 3 months

You may not qualify if:

  • Bilateral amputation
  • Cancer
  • Absence of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Pierre Abraham

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 17, 2015

Study Start

March 9, 2015

Primary Completion

February 1, 2017

Study Completion

April 12, 2017

Last Updated

November 1, 2017

Record last verified: 2016-12

Locations

FR(1)