Trial Outcomes & Findings for Botulinum Toxin Effects on Plantar Ulcer Recurrence (NCT NCT00845897)

Results Overview

Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing \& Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing

Results posted on

2012-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Group Placebo (saline) injections into 6 sites in the calf muscle	200 Units of Botox Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.	300 Units of Botox 300 units of botulinum toxin injected into 6 sites in the calf muscle
Overall Study STARTED	5	7	5
Overall Study COMPLETED	3	2	2
Overall Study NOT COMPLETED	2	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Group Placebo (saline) injections into 6 sites in the calf muscle	200 Units of Botox Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.	300 Units of Botox 300 units of botulinum toxin injected into 6 sites in the calf muscle
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	0	3	2
Overall Study Ulcer did not heal	1	0	1
Overall Study Too ill to participate	0	1	0

Baseline Characteristics

Botulinum Toxin Effects on Plantar Ulcer Recurrence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=5 Participants Placebo (saline) injections into 6 sites in the calf muscle	200 Units of Botox n=7 Participants Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.	300 Units of Botox n=5 Participants 300 units of botulinum toxin injected into 6 sites in the calf muscle	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	17 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing

Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing \& Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.

Outcome measures

Outcome measures
Measure	Botulinum Toxin 200 Units n=7 Participants 200 units of Botox®	Placebo n=5 Participants Saline	Botulinum Toxin 300 Units n=5 Participants 300 units of Botox®
Plantar Flexor Muscle Strength	-8 Plantar Flexor Torque (Nm) Standard Deviation 11	3 Plantar Flexor Torque (Nm) Standard Deviation 4	6 Plantar Flexor Torque (Nm) Standard Deviation 10

SECONDARY outcome

Timeframe: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing

Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm\^2.

Outcome measures

Outcome measures
Measure	Botulinum Toxin 200 Units n=7 Participants 200 units of Botox®	Placebo n=5 Participants Saline	Botulinum Toxin 300 Units n=5 Participants 300 units of Botox®
Barefoot Plantar Pressure	-4 Peak Plantar Pressure (N/cm^2) changes Standard Deviation 16	0 Peak Plantar Pressure (N/cm^2) changes Standard Deviation 11	0 Peak Plantar Pressure (N/cm^2) changes Standard Deviation 5

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

200 Units of Botox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

300 Units of Botox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Hastings PT, DPT, ATC

Washington University School of Medicine

Phone: 314 286 1433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place