Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis

Double-blind, Placebo-controlled, Randomised, Multicentre Study on the Efficacy and Safety of a Single Injection of Botulinum Toxin A (200 Units Dysport®) in the Treatment of Chronic Plantar Fasciitis

Sponsors

Lead Sponsor: Ipsen

Source Ipsen
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.

Overall Status Completed
Start Date July 2005
Completion Date April 2009
Primary Completion Date January 2009
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Responders Rate at Week 6 (Pain While Moving) Baseline and Week 6
Secondary Outcome
Measure Time Frame
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline and Week 18
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study Baseline and Weeks 2, 6, 10, 14 and 18
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Assessment of SPID for Continuous Pain for Overall Study Baseline and Weeks 2, 6, 10, 14 and 18
Changes From Baseline in Pain Threshold at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study Baseline and Weeks 2, 6, 10, 14 and 18
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study Baseline and Weeks 2, 6, 10, 14 and 18
Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 Baseline and Week 18
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Baseline and Weeks 2, 6, 10, 14 and 18
Enrollment 40
Condition
Intervention

Intervention Type: Biological

Intervention Name: Botulinum toxin type A

Description: Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia

Arm Group Label: Botulinum type A toxin (Dysport®)

Other Name: AbobotulinumtoxinA (Dysport®)

Intervention Type: Drug

Intervention Name: Placebo

Description: 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ipsen Medical Director Study Director Ipsen
Location
Facility:
University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic | Berlin, 13353, Germany
Orthopedic Practice Biberburg | Berlin, 14089, Germany
Orthopedic Practice | Karlsruhe, 76133, Germany
Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH | Marburg, Germany
Orthocentre Munich | Munich, 81547, Germany
Orthopedic Practice | Weiden, 92637, Germany
Location Countries

Germany

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Botulinum type A toxin (Dysport®)

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov