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Impact of Conservative Treatment by Custom-Made Orthoses in Patients With Haemophilic Ankle Arthropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00638001
First received: February 26, 2008
Last updated: January 16, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Haemophilia A
Haemophilia B
 Device: custom-molded insoles and custom-molded shoes
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Gait analysis, foot pressure measurement, specific joint score [ Time Frame: To, T1 (3months) and T2 (6months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: custom-molded insoles and custom-molded shoes
    • 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

Ages Eligible for Study:   13 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • haemophilia A or B, aged more than 13 years

Exclusion Criteria:

  • impossibility to walk on a treadmill
  • recent joint haemarthrosis or muscle haematoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638001

Contacts
Contact: sebastien lobet 003227641657 sebastien.lobet@uclouvain.be

Locations
Belgium
cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium, 1200
Contact: sebastien lobet     003227641657     sebastien.lobet@uclouvain.be    
Principal Investigator: sebastien Lobet            
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc, service d'hématologie
ClinicalTrials.gov Identifier: NCT00638001     History of Changes
Other Study ID Numbers: READ-LOBET-01
Study First Received: February 26, 2008
Last Updated: January 16, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
patients with haemophilia A moderate or severe
patients with haemophilia B moderate or severe

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 22, 2013