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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD048972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
Please read "Brief Summary"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo (saline) injections into 6 sites in the calf muscle |
|
| 2 | Active Comparator | Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. |
|
| 3 | Active Comparator | 300 units of botulinum toxin injected into 6 sites in the calf muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary K Hastings, PT, DPT, ATC | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Placebo (saline) injections into 6 sites in the calf muscle |
| FG001 | 200 Units of Botox | Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. |
| FG002 | 300 Units of Botox | 300 units of botulinum toxin injected into 6 sites in the calf muscle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Placebo (saline) injections into 6 sites in the calf muscle |
| BG001 | 200 Units of Botox | Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Plantar Flexor Torque (Nm) | Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Group | Placebo (saline) injections into 6 sites in the calf muscle |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Hastings PT, DPT, ATC | Washington University School of Medicine | 314 286 1433 | hastingsmk@wustl.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010523 | Peripheral Nervous System Diseases |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Saline | Drug | 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 |
|
| Ulcer did not heal |
|
| Too ill to participate |
|
| BG002 | 300 Units of Botox | 300 units of botulinum toxin injected into 6 sites in the calf muscle |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Saline |
| OG002 | Botulinum Toxin 300 Units | 300 units of Botox® |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Peak Plantar Pressure (N/cm^2) changes | pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 200 Units of Botox | Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. | 0 | 7 | 0 | 7 |
| EG002 | 300 Units of Botox | 300 units of botulinum toxin injected into 6 sites in the calf muscle | 0 | 5 | 0 | 5 |
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| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |