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

Ipsen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Plantar Fasciitis

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447876

2004-002533-39 (EudraCT Number)

A-94-52120-100

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Botulinum type A toxin (Dysport®)

Experimental group

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo