Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis (NCT NCT00447876)

Last Updated: 2019-11-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2019-11-22

Participant Flow

The study was a double-blind, placebo-controlled, randomized, prospective study where patients were recruited to 5 study centres in Germany. Patients were enrolled to the study from 08 July 2005 (first patent enrolled) until 23 April 2009 (last patient completed).

40 patients were enrolled. Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. All patients enrolled were randomized and received study treatment.

Participant milestones

Participant milestones
Measure	Dysport ® 200 U Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Overall Study STARTED	20	20
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dysport ® 200 U Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	1	0
Overall Study Deterioration of symptomology	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Total Title n=40 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	51.8 years STANDARD_DEVIATION 11.3 • n=7 Participants	52.1 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: The Intention-To-Treat (ITT) analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least once at a later timepoint. Missing values were replaced using the last observation carried forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Responders Rate at Week 6 (Pain While Moving)	25.0 Percentage of participants	5.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable could only be analyzed for 30 patients (15 from each group) for whom the score could be determined both at baseline and at 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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=15 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=15 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = I; Week 18 score = I	40.0 Percentage of participants	60.0 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = II; Week 18 score = III	6.7 Percentage of participants	0.0 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = III; Week 18 score = I	6.7 Percentage of participants	6.7 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = II; Week 18 score = I	26.7 Percentage of participants	6.7 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = II; Week 18 score = II	6.7 Percentage of participants	20.0 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = III; Week 18 score = II	6.7 Percentage of participants	6.7 Percentage of participants
Changes From Baseline in Gerbershagen's Score at Week 18 Baseline score = III; Week 18 score = III	6.7 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit PID Week 2 (maximum pain)	-1.38 Centimeter (cm) Standard Deviation 2.66	-1.18 Centimeter (cm) Standard Deviation 1.98
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit PID Week 6 (maximum pain)	-1.55 Centimeter (cm) Standard Deviation 3.27	-1.35 Centimeter (cm) Standard Deviation 1.85
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit PID Week 10 (maximum pain)	-1.75 Centimeter (cm) Standard Deviation 3.32	-1.25 Centimeter (cm) Standard Deviation 1.99
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit PID Week 14 (maximum pain)	-2.48 Centimeter (cm) Standard Deviation 3.59	-1.30 Centimeter (cm) Standard Deviation 2.59
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit PID Week 18 (maximum pain)	-2.45 Centimeter (cm) Standard Deviation 3.52	-1.80 Centimeter (cm) Standard Deviation 3.17

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study	-28.043 cm * day Interval -43.672 to -12.415	-19.207 cm * day Interval -34.835 to -3.578

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit PID Week 2 (continuous pain)	-0.78 cm Standard Deviation 2.80	-0.88 cm Standard Deviation 2.19
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit PID Week 6 (continuous pain)	-0.45 cm Standard Deviation 2.70	-1.05 cm Standard Deviation 1.76
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit PID Week 10 (continuous pain)	-0.63 cm Standard Deviation 2.67	-1.20 cm Standard Deviation 2.98
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit PID Week 14 (continuous pain)	-1.75 cm Standard Deviation 2.99	-0.98 cm Standard Deviation 2.91
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit PID Week 18 (continuous pain)	-1.55 cm Standard Deviation 3.38	-1.70 cm Standard Deviation 3.75

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Assessment of SPID for Continuous Pain for Overall Study	-17.511 cm * day Interval -31.838 to -3.184	-13.339 cm * day Interval -27.666 to 0.988

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Changes From Baseline in Pain Threshold at Each Visit Pain threshold difference Week 2	0.80 Kilogram (kg) / cm^2 Standard Deviation 2.28	0.76 Kilogram (kg) / cm^2 Standard Deviation 1.73
Changes From Baseline in Pain Threshold at Each Visit Pain threshold difference Week 6	0.51 Kilogram (kg) / cm^2 Standard Deviation 2.90	1.31 Kilogram (kg) / cm^2 Standard Deviation 3.95
Changes From Baseline in Pain Threshold at Each Visit Pain threshold difference Week 10	0.69 Kilogram (kg) / cm^2 Standard Deviation 2.86	1.50 Kilogram (kg) / cm^2 Standard Deviation 3.51
Changes From Baseline in Pain Threshold at Each Visit Pain threshold difference Week 14	0.85 Kilogram (kg) / cm^2 Standard Deviation 3.41	1.35 Kilogram (kg) / cm^2 Standard Deviation 2.97
Changes From Baseline in Pain Threshold at Each Visit Pain threshold difference Week 18	0.83 Kilogram (kg) / cm^2 Standard Deviation 3.23	2.16 Kilogram (kg) / cm^2 Standard Deviation 3.93

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study	11.492 (kg / cm^2) * day Interval -3.238 to 26.223	19.558 (kg / cm^2) * day Interval 4.827 to 34.288

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Pressure threshold difference Week 2	0.55 kg / cm^2 Standard Deviation 2.21	0.95 kg / cm^2 Standard Deviation 1.76
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Pressure threshold difference Week 6	0.90 kg / cm^2 Standard Deviation 2.62	1.07 kg / cm^2 Standard Deviation 2.01
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Pressure threshold difference Week 10	0.61 kg / cm^2 Standard Deviation 1.79	1.33 kg / cm^2 Standard Deviation 2.29
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Pressure threshold difference Week 14	1.38 kg / cm^2 Standard Deviation 2.77	1.13 kg / cm^2 Standard Deviation 2.20
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit Pressure threshold difference Week 18	1.74 kg / cm^2 Standard Deviation 2.98	1.28 kg / cm^2 Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 6, 10, 14 and 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study	16.174 (kg / cm^2) * day Interval 5.462 to 26.886	15.581 (kg / cm^2) * day Interval 4.869 to 26.293

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable was only analyzed for 34 patients (18 for Dysport® and 16 for Placebo) for whom ROM was determined at both 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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=18 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=16 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18	60.7 Degrees Interval 56.6 to 64.8	61.4 Degrees Interval 57.1 to 65.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 2 unchanged	9 Number of participants	9 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 2 significantly worse	0 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 2 slightly worse	1 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 2 slightly improved	7 Number of participants	6 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 2 significantly improved	3 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 6 significantly worse	2 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 6 slightly worse	0 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 6 unchanged	6 Number of participants	9 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 6 slightly improved	7 Number of participants	8 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 6 significantly improved	4 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 10 significantly worse	2 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 10 slightly worse	2 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 10 unchanged	2 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 10 slightly improved	7 Number of participants	10 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 10 significantly improved	3 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 14 significantly worse	2 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 14 slightly worse	1 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 14 unchanged	4 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 14 slightly improved	7 Number of participants	7 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 14 significantly improved	4 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 18 significantly worse	2 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 18 slightly worse	0 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 18 unchanged	4 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 18 slightly improved	6 Number of participants	8 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit Week 18 significantly improved	6 Number of participants	4 Number of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dysport ® 200 U n=20 Participants Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 Participants Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 14 slightly improved	7 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 14 significantly improved	3 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 14 significantly worse	2 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 2 significantly worse	0 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 2 slightly worse	3 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 2 unchanged	7 Number of participants	9 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 2 slightly improved	7 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 2 significantly improved	3 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 6 significantly worse	3 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 6 slightly worse	0 Number of participants	1 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 6 unchanged	6 Number of participants	9 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 6 slightly improved	6 Number of participants	6 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 6 significantly improved	4 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 10 significantly worse	4 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 10 slightly worse	2 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 10 unchanged	3 Number of participants	3 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 10 slightly improved	4 Number of participants	7 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 10 significantly improved	4 Number of participants	4 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 14 slightly worse	3 Number of participants	2 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 14 unchanged	3 Number of participants	4 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 18 significantly worse	3 Number of participants	5 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 18 slightly worse	2 Number of participants	0 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 18 unchanged	2 Number of participants	4 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 18 slightly improved	5 Number of participants	7 Number of participants
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit Week 18 significantly improved	7 Number of participants	4 Number of participants

Adverse Events

Dysport ® 200 U

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dysport ® 200 U n=20 participants at risk Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 participants at risk Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Infections and infestations Diverticulitis	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Gastrointestinal disorders Gastrointestinal inflammation	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.

Other adverse events

Additional Information

Medical Director

Ipsen

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dysport ® 200 U n=20 participants at risk Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.	Placebo n=20 participants at risk Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 2/20 • Number of events 2 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Arthropathy	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Plantar fasciitis	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	10.0% 2/20 • Number of events 2 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Synovial cyst	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Trigger finger	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	10.0% 2/20 • Number of events 2 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Gastrointestinal disorders Haemorrhoids	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Infections and infestations Tinea pedis	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Infections and infestations Nasopharyngitis	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
General disorders Injection site pain	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Injury, poisoning and procedural complications Fall	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Injury, poisoning and procedural complications Contusion	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	5.0% 1/20 • Number of events 2 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Respiratory, thoracic and mediastinal disorders Asthma	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.	0.00% 0/20 • Up to Week 18 Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.