Back to resultsBotulinum Toxin Effects on Plantar Ulcer Recurrence
Primary Purpose
Diabetes Mellitus, Peripheral Neuropathy, Plantar Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, plantar ulcers, peripheral neuropathy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
- A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
- Ambulatory
Exclusion Criteria:
- Active infection in the involved foot
- Previous botulinum toxin injections
- Ulcers on the dorsal surface of the foot
- Ankle-brachial index <0.45
- History of cerebral vascular accident or other neurological problems complicating their rehabilitation
- Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
- Current drug therapy that includes an anticoagulant
- History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Placebo (saline) injections into 6 sites in the calf muscle
Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
300 units of botulinum toxin injected into 6 sites in the calf muscle
Outcomes
Primary Outcome Measures
Plantar Flexor Muscle Strength
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.
Secondary Outcome Measures
Barefoot Plantar Pressure
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.
Full Information
NCT ID
NCT00845897
First Posted
February 16, 2009
Last Updated
February 1, 2012
Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00845897
Brief Title
Botulinum Toxin Effects on Plantar Ulcer Recurrence
Official Title
Botulinum Toxin Effects on Plantar Ulcer Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The decrease in plantar pressure will provide temporary protection to the new tissue as it gains tolerance to high stress with the long term potential outcome as a decrease in the ulcer recurrence rate.
Detailed Description
Please read "Brief Summary"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Peripheral Neuropathy, Plantar Ulcers
Keywords
Diabetes mellitus, plantar ulcers, peripheral neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo (saline) injections into 6 sites in the calf muscle
Arm Title
2
Arm Type
Active Comparator
Arm Description
Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
Arm Title
3
Arm Type
Active Comparator
Arm Description
300 units of botulinum toxin injected into 6 sites in the calf muscle
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin
Other Intervention Name(s)
botox
Intervention Description
200 units of botulinum toxin, and 300 units of botulinum toxin. Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Placebo (saline) (3cc). Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus
Primary Outcome Measure Information:
Title
Plantar Flexor Muscle Strength
Description
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.
Time Frame
Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing
Secondary Outcome Measure Information:
Title
Barefoot Plantar Pressure
Description
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.
Time Frame
pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
Ambulatory
Exclusion Criteria:
Active infection in the involved foot
Previous botulinum toxin injections
Ulcers on the dorsal surface of the foot
Ankle-brachial index <0.45
History of cerebral vascular accident or other neurological problems complicating their rehabilitation
Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
Current drug therapy that includes an anticoagulant
History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary K Hastings, PT, DPT, ATC
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
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Botulinum Toxin Effects on Plantar Ulcer Recurrence
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