Phase 3 N=40 Randomized Double-blind Treatment

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

Chronic Plantar Fasciitis

Bottom Line

View on ClinicalTrials.gov: NCT00447876 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Jun 2017

Primary outcome: Primary: Responders Rate at Week 6 (Pain While Moving) — 25.0; 5.0 Percentage of participants — p==0.182

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Botulinum toxin type A (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Responders Rate at Week 6 (Pain While Moving)	25.0; 5.0	=0.182
SECONDARY Changes From Baseline in Gerbershagen's Score at Week 18	40.0; 60.0; 26.7; 6.7; 6.7; 20.0	=0.222
SECONDARY Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit	-1.38; -1.18; -1.55; -1.35; -1.75; -1.25	—
SECONDARY Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study	-28.043; -19.207	=0.423
SECONDARY Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit	-0.78; -0.88; -0.45; -1.05; -0.63; -1.20	—
SECONDARY Assessment of SPID for Continuous Pain for Overall Study	-17.511; -13.339	=0.682
SECONDARY Changes From Baseline in Pain Threshold at Each Visit	0.80; 0.76; 0.51; 1.31; 0.69; 1.50	—
SECONDARY Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study	11.492; 19.558	=0.438
SECONDARY Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit	0.55; 0.95; 0.90; 1.07; 0.61; 1.33	—
SECONDARY Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study	16.174; 15.581	=0.937
SECONDARY Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18	60.7; 61.4	=0.800
SECONDARY Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit	0; 0; 1; 0; 9; 9	=0.862
SECONDARY Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit	0; 0; 3; 2; 7; 9	=0.882

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00447876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.