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NCT00638001 Clinical Trial

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

Haemophilia A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00638001
Other study ID # READ-LOBET-01
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2008
Last updated July 10, 2014
Start date March 2008
Est. completion date March 2012

Study information
Verified date July 2014
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Male
Age group 13 Years to 80 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium cliniques Universitaires Saint Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gait analysis, foot pressure measurement, specific joint score To, T1 (3months) and T2 (6months) Yes
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