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

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ClinicalTrials.gov Identifier: NCT00638001
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Haemophilia A Haemophilia B Device: custom-molded insoles and custom-molded shoes Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Gait analysis, foot pressure measurement, specific joint score [ Time Frame: To, T1 (3months) and T2 (6months) ]


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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638001


Locations
Belgium
cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00638001     History of Changes
Other Study ID Numbers: READ-LOBET-01
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

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 A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked