Compartment Syndrome of Leg
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBotox
reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 undergone a hysterectomy or bilateral oophorectomy; or * 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
* History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes * Known neuromuscular disease * Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection * Dysphagia * Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction * Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to enrollment * Currently or have taken in the past medications that affect neuromuscular function, aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto * Women who are pregnant or breast-feeding * Vulnerable populations * Not suitable for study participation due to other reasons at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | 2 months, 4 months, 6 months | 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. |
| Number of Participants With Lower Extremity Weakness | up to 6 months | A primary safety endpoint is incidence of lower extremity weakness, measured by |
| Incidence of Adverse Events | one study visit (within 2 hours) | A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankle Eversion Strength Using Kiio Force Sensor | baseline and month 2 | 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). |
| Change in Ability to Perform Activities of Daily Living | baseline, 2 months, 4 months, 6 months | 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. |
| Participant Frustration With Injury | baseline, 2 months, 4 months, 6 months | 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. |
| Participant Perception of Recovery From Injury | baseline, 2 months, 4 months, 6 months | 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. |
| Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor | baseline and month 2 | 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). |
| Change in Running Duration: Weekly | baseline, 2 months, 4 months, 6 months | 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. |
| Change in Running Duration: Longest Run | baseline, 2 months, 4 months, 6 months | 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. |
| Change in Running Speed | baseline, 2 months, 4 months, 6 months | 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. |
| Participant Confidence in Increasing the Duration and Intensity of Running | baseline, 2 months, 4 months, 6 months | 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. |
| Pain in the 24 Hours Following Running | baseline, 2 months, 4 months, 6 months | 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. |
| Change in Ankle Plantarflexion Strength Using Kiio Force Sensor | baseline and month 2 | 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). |
| Change in Ankle Inversion Strength Using Kiio Force Sensor | baseline and month 2 | 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). |
Countries
United States
Participant flow
Recruitment details
One participant was enrolled in November of 2022
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | PI terminated study for problems with strength testing equipment | 1 |
Baseline characteristics
| Characteristic | Participants With R-CECS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: 2 months, 4 months, 6 months
Population: only baseline data collected before study was terminated
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in Pain Score | 2 months | — |
| Unknown | Change in Pain Score | 4 months | — |
| Unknown | Change in Pain Score | 6 months | — |
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.
Time frame: one study visit (within 2 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With R-CECS - Left Leg | Incidence of Adverse Events | 0 Participants |
Primary
Number of Participants With Lower Extremity Weakness
A primary safety endpoint is incidence of lower extremity weakness, measured by
Time frame: up to 6 months
Population: study terminated early
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Ability to Perform Activities of Daily Living | baseline | 2 score on a scale |
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).
Time frame: baseline and month 2
Population: strength equipment not functional, study terminated as a result
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor | baseline | 24.9 pounds of force |
| Participants With R-CECS - Right Leg | Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor | baseline | 25.2 pounds of force |
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).
Time frame: baseline and month 2
Population: strength equipment not functional, study terminated as a result
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Ankle Eversion Strength Using Kiio Force Sensor | baseline | 22.7 pounds of force |
| Participants With R-CECS - Right Leg | Change in Ankle Eversion Strength Using Kiio Force Sensor | baseline | 22.8 pounds of force |
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).
Time frame: baseline and month 2
Population: strength equipment not functional, study terminated as a result
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Ankle Inversion Strength Using Kiio Force Sensor | baseline | 22.9 pounds of force |
| Participants With R-CECS - Right Leg | Change in Ankle Inversion Strength Using Kiio Force Sensor | baseline | 22.8 pounds of force |
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).
Time frame: baseline and month 2
Population: strength equipment not functional, study terminated as a result
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Ankle Plantarflexion Strength Using Kiio Force Sensor | baseline | 154.3 pounds of force |
| Participants With R-CECS - Right Leg | Change in Ankle Plantarflexion Strength Using Kiio Force Sensor | baseline | 156.4 pounds of force |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Running Duration: Longest Run | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Running Duration: Weekly | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Change in Running Speed | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Pain in the 24 Hours Following Running | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Participant Confidence in Increasing the Duration and Intensity of Running | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Participant Frustration With Injury | baseline | 0 score on a scale |
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.
Time frame: baseline, 2 months, 4 months, 6 months
Population: study was terminated after baseline measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With R-CECS - Left Leg | Participant Perception of Recovery From Injury | baseline | 0 score on a scale |