Status:
COMPLETED
Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis
Lead Sponsor:
Ipsen
Conditions:
Chronic Plantar Fasciitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.
Eligibility Criteria
Inclusion
- Chronic plantar fasciitis (duration of disorder at least 4 months)
- At least 4 points on the visual analogue scale (0-10) for the most severe pain within the last 48 hours
- At least 2 previous unsuccessful conservative therapies
- Age 18 and older
Exclusion
- Rheumatoid diseases (M. Bechterew, chronic polyarthritis, psoriasis-arthritis, para /post-infectious arthritis etc.)
- Previous surgery in the affected area of the foot
- Pre-treatment with Botulinum toxin A (only de novo patients)
- Prohibited concomitant treatment: local injections during the study and 2 weeks prior to start of study
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00447876
Start Date
July 1 2005
End Date
April 1 2009
Last Update
November 22 2019
Active Locations (6)
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1
University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic
Berlin, Germany, 13353
2
Orthopedic Practice Biberburg
Berlin, Germany, 14089
3
Orthopedic Practice
Karlsruhe, Germany, 76133
4
Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany