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

• ClinicalTrials.gov Identifier: NCT00447876
• Recruitment Status: Completed
• First Posted: March 15, 2007
• Results First Posted: June 23, 2017
• Last Update Posted: November 22, 2019
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Tracking Information

• First Submitted Date: March 13, 2007
• First Posted Date: March 15, 2007
• Results First Submitted Date: April 6, 2017
• Results First Posted Date: June 23, 2017
• Last Update Posted Date: November 22, 2019
• Study Start Date: July 2005
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2017)

Responders Rate at Week 6 (Pain While Moving) [ Time Frame: Baseline and Week 6 ]

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.

• Original Primary Outcome Measures (submitted: March 13, 2007): Improvement of score value on the visual analogue scale for pain during weight-bearing in the last 48 hours in week 6. "Responder" is defined as a reduction in score value of ≥ 50%

Current Secondary Outcome Measures (submitted: April 6, 2017)

• Changes From Baseline in Gerbershagen's Score at Week 18 [ Time Frame: Baseline and Week 18 ]
  The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen's global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.
• Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.
• Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.
• Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.
• Assessment of SPID for Continuous Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.
• Changes From Baseline in Pain Threshold at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.
• Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.
• Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.
• Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.
• Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 [ Time Frame: Baseline and Week 18 ]
  Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.
• Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.
• Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
  A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.

Original Secondary Outcome Measures (submitted: March 13, 2007)

• Gerbershagen Score at first visit and at week 18
• Pain intensity on the Visual Analogue Scale
• Measurement of pressure pain with algorimeter: most severe pain experienced on the medial hindfoot
• Force measurement by Brunner (Grade 0-5)
• Global assessment by the investigator and the patient at weeks 2, 6, 10, 14, 18 post injection
• Tolerance of study drug (recording of drug side-effects)
• Adverse events

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Plantar Fasciitis

Intervention

• Biological: Botulinum toxin type A
  Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
  Other Name: AbobotulinumtoxinA (Dysport®)
• Drug: Placebo
  0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

Study Arms

• Experimental: Botulinum type A toxin (Dysport®)
  Intervention: Biological: Botulinum toxin type A
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Peterlein CD, Funk JF, Hölscher 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 13, 2007): 40
• Original Enrollment: Same as current
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00447876
• Other Study ID Numbers: A-94-52120-100; 2004-002533-39 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ipsen
• Original Responsible Party: Not Provided
• Current Study Sponsor: Ipsen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Medical Director; Ipsen

• PRS Account: Ipsen
• Verification Date: November 2019