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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulinum type A toxin (Dysport®)

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Botulinum toxin type A

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type DRUG

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No