NCT00638001

Brief Summary

The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the orthoses' impact on foot health-related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 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

First Submitted

Initial submission to the registry

February 26, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

4 years

First QC Date

February 26, 2008

Last Update Submit

July 10, 2014

Conditions

Haemophilia AHaemophilia B

Keywords

patients with haemophilia A moderate or severepatients with haemophilia B moderate or severe

Outcome Measures

Primary Outcomes (1)

  • Gait analysis, foot pressure measurement, specific joint score

    To, T1 (3months) and T2 (6months)

Interventions

custom-molded insoles and custom-molded shoesDEVICE

* custom-made insoles in "PELITE" foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy * custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy

Eligibility Criteria

Age13 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • haemophilia A or B, aged more than 13 years

You may not qualify if:

  • impossibility to walk on a treadmill
  • recent joint haemarthrosis or muscle haematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 18, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

BE(1)