NCT00447876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2017

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3.5 years

First QC Date

March 13, 2007

Results QC Date

April 6, 2017

Last Update Submit

November 21, 2019

Conditions

Chronic Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • Responders Rate at Week 6 (Pain While Moving)

    The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.

    Baseline and Week 6

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Botulinum type A toxin (Dysport®)

EXPERIMENTAL
Biological: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Botulinum toxin type ABIOLOGICAL

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

Also known as: AbobotulinumtoxinA (Dysport®)
Botulinum type A toxin (Dysport®)
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic

Berlin, 13353, Germany

Location

Orthopedic Practice Biberburg

Berlin, 14089, Germany

Location

Orthopedic Practice

Karlsruhe, 76133, Germany

Location

Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH

Marburg, Germany

Location

Orthocentre Munich

Munich, 81547, Germany

Location

Orthopedic Practice

Weiden, 92637, Germany

Location

Related Publications (1)

  • Peterlein CD, Funk JF, Holscher A, Schuh A, Placzek R. Is botulinum toxin A effective for the treatment of plantar fasciitis? Clin J Pain. 2012 Jul;28(6):527-33. doi: 10.1097/AJP.0b013e31823ae65a.

    PMID: 22673486RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Medical Director
Organization
Ipsen
clinical.trials@ipsen.com

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

July 1, 2005

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

November 22, 2019

Results First Posted

June 23, 2017

Record last verified: 2019-11

Locations

DE(6)