NCT00616668

Brief Summary

The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

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

January 1, 2003

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

First QC Date

February 4, 2008

Last Update Submit

February 14, 2008

Conditions

Vascular Diseases

Keywords

Transtibial amputees due to vascular diseases.

Outcome Measures

Primary Outcomes (2)

  • The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.

    1-4 month

  • The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.

    2-6 month

Secondary Outcomes (1)

  • The duration of stump healing and functional status of transtibial amputees.

    1-6 month

Interventions

Air- LimbDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Transtibial amputees due to vascular diseases.

You may not qualify if:

  • Bilateral amputation.
  • Upper extremity can't bear weight.
  • The sound leg can't bear weight.
  • Amputee that needs Dialysis treatment.
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Itzhak Siev- Ner, MD

    Sheba Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

January 1, 2003

Study Completion

December 1, 2005

Last Updated

February 15, 2008

Record last verified: 2008-02