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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 8/4/2021 | Other Identifier | UW Madison | |
| A536120 | Other Identifier | UW Madison | |
| SMPH/ORTHO&REHAB/REHAB MED | Other Identifier | UW Madison |
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issues with supplier of strength testing equipment, presumed to go out of business
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10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.
Participants will be enrolled in study at initial clinic visit by study staff at which time diagnosis of R-CECS will be established based on elevated pressure measurements in patients who have had surgical release of the affected compartments. Pressure testing will be performed outside of the clinical study and will be required to establish the diagnosis of R-CECS.
Initial clinic visit with study staff will consist of baseline measurements of ankle plantarflexion, dorsiflexion, inversion, and eversion strength using Kiio Force Sensor. The clinic visit with study staff will establish time point 0 and will consist of written consent for participation, Botox injection, and baseline University of Wisconsin Running Index (UWRI). Two months following this visit, the participant will have follow up with study staff. Study staff will again measure ankle strength (ankle inversion, eversion, plantarflexion, and dorsiflexion) using the Kiio Force Sensor utilizing the same strength assessment protocol. Study staff will monitor for side effects and administer the UWRI. Telephone follow up assessment of the UWRI will be made by study staff at 4 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with R-CECS | Experimental | Botox to be injected under standard palpatory technique into the affected lower leg compartment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | reconstituted at 100 units/mL, dosage will be based upon the affected muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA. | 2 months, 4 months, 6 months |
| Number of Participants With Lower Extremity Weakness | A primary safety endpoint is incidence of lower extremity weakness, measured by | up to 6 months |
| Incidence of Adverse Events | A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given. | one study visit (within 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | baseline and month 2 |
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Inclusion Criteria:
Willing to provide written informed consent
Willing to comply with all study procedures and be available for the duration of the study
Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy)
Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Suer, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705 | United States |
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One participant was enrolled in November of 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With R-CECS | Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With R-CECS | Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected 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 | Change in Pain Score | Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA. | only baseline data collected before study was terminated | Posted | 2 months, 4 months, 6 months |
|
one study visit (within 2 hours)
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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 | Participants With R-CECS | Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Suer, MD | UW School of Medicine and Public Health | (608) 265-3207 | suer@rehab.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2021 | Jun 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Change in Ankle Plantarflexion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | baseline and month 2 |
| Change in Ankle Inversion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | baseline and month 2 |
| Change in Ankle Eversion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | baseline and month 2 |
| Change in Ability to Perform Activities of Daily Living | A question on the University of Wisconsin Running Index (UWRI) asks the participant to indicate how their running injury impacts their ability to perform daily activities. The scoring is on a 5 point likert scale from 0 = unable to perform, 1 = significantly impact, 2 = moderately impact, 3 = slightly impact, to 4 = no impact. | baseline, 2 months, 4 months, 6 months |
| Participant Frustration With Injury | A question on the UWRI asks the participant to indicate how frustrated they are by their running injury. The scoring is on a 5 point likert scale from 0 = extremely frustrated, 1 = significantly frustrated, 2 = moderately frustrated, 3 = mildly frustrated, to 4 = not frustrated. | baseline, 2 months, 4 months, 6 months |
| Participant Perception of Recovery From Injury | A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury. The scoring is on a 5 point likert scale from 0 = no recovery, 1 = minimal recovery, 2 = moderate recovery, 3 = significant recovery, to 4 = complete recovery. | baseline, 2 months, 4 months, 6 months |
| Pain in the 24 Hours Following Running | A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significant pain, 2 = moderate pain, 3 = minimal pain, to 4 = no pain. | baseline, 2 months, 4 months, 6 months |
| Change in Running Duration: Weekly | A question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or greater than before my injury. | baseline, 2 months, 4 months, 6 months |
| Change in Running Duration: Longest Run | A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury. | baseline, 2 months, 4 months, 6 months |
| Change in Running Speed | A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury. | baseline, 2 months, 4 months, 6 months |
| Participant Confidence in Increasing the Duration and Intensity of Running | A question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running. The scoring is on a 5 point likert scale from 0 = I cannot increase my running, 1 = if I increase, I might get worse, 2 = neutral, 3 = if I increase I might be fine, to 4 = confident to increase my running. | baseline, 2 months, 4 months, 6 months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Lower Extremity Weakness | A primary safety endpoint is incidence of lower extremity weakness, measured by | study terminated early | Posted | up to 6 months |
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| Primary | Incidence of Adverse Events | A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given. | Posted | Count of Participants | Participants | one study visit (within 2 hours) |
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| Secondary | Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | strength equipment not functional, study terminated as a result | Posted | Number | pounds of force | baseline and month 2 |
|
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| Secondary | Change in Ankle Plantarflexion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | strength equipment not functional, study terminated as a result | Posted | Number | pounds of force | baseline and month 2 |
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| Secondary | Change in Ankle Inversion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | strength equipment not functional, study terminated as a result | Posted | Number | pounds of force | baseline and month 2 |
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| Secondary | Change in Ankle Eversion Strength Using Kiio Force Sensor | A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs). | strength equipment not functional, study terminated as a result | Posted | Number | pounds of force | baseline and month 2 |
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| Secondary | Change in Ability to Perform Activities of Daily Living | A question on the University of Wisconsin Running Index (UWRI) asks the participant to indicate how their running injury impacts their ability to perform daily activities. The scoring is on a 5 point likert scale from 0 = unable to perform, 1 = significantly impact, 2 = moderately impact, 3 = slightly impact, to 4 = no impact. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Participant Frustration With Injury | A question on the UWRI asks the participant to indicate how frustrated they are by their running injury. The scoring is on a 5 point likert scale from 0 = extremely frustrated, 1 = significantly frustrated, 2 = moderately frustrated, 3 = mildly frustrated, to 4 = not frustrated. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Participant Perception of Recovery From Injury | A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury. The scoring is on a 5 point likert scale from 0 = no recovery, 1 = minimal recovery, 2 = moderate recovery, 3 = significant recovery, to 4 = complete recovery. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Pain in the 24 Hours Following Running | A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significant pain, 2 = moderate pain, 3 = minimal pain, to 4 = no pain. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Change in Running Duration: Weekly | A question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or greater than before my injury. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Change in Running Duration: Longest Run | A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Change in Running Speed | A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| Secondary | Participant Confidence in Increasing the Duration and Intensity of Running | A question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running. The scoring is on a 5 point likert scale from 0 = I cannot increase my running, 1 = if I increase, I might get worse, 2 = neutral, 3 = if I increase I might be fine, to 4 = confident to increase my running. | study was terminated after baseline measure | Posted | Number | score on a scale | baseline, 2 months, 4 months, 6 months |
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| D006867 |
| Hydrolases |
| 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 |
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