Compartment Syndrome of LegPhase 4NCT05006417
Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
A Phase 4 study testing Botox in people with Compartment Syndrome of Leg, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compartment Syndrome of Leg
- What is being tested?
- Botox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2022to 23 Nov 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
About this study
Official title: OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
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.
Read the 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.
- Conditions
- Compartment Syndrome of Leg
- Being tested
- Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Also called OnabotulinumtoxinA
reconstituted at 100 units/mL, dosage will be based upon the affected muscles
| Study group | Role | What they receive |
|---|---|---|
| Participants with R-CECS | Experimental | Botox to be injected under standard palpatory technique into the affected lower leg compartment. Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: one study visit (within 2 hours)
Secondary outcomes (12)
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).
Measured: baseline and month 2
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start23 Nov 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Why it stopped: issues with supplier of strength testing equipment, presumed to go out of business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Compartment Syndrome of LegStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Suer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006417
- Sponsor's protocol ID
- 2020-1375
- Other IDs
- Protocol Version 8/4/2021, A536120, SMPH/ORTHO&REHAB/REHAB MED
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2021
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT05006417
- Acronym / sponsor ID
- 2020-1375
- Conditions
- Compartment Syndrome of Leg
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: issues with supplier of strength testing equipment, presumed to go out of business
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with R-CECS | Experimental | Drug: BotoxBotox to be injected under standard palpatory technique into the affected lower leg compartment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxAlso: OnabotulinumtoxinAreconstituted at 100 units/mL, dosage will be based upon the affected muscles | Drug | Participants with R-CECS |
Primary outcome
Change in Pain Score
Time frame: 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
Time frame: up to 6 months
A primary safety endpoint is incidence of lower extremity weakness, measured by
Incidence of Adverse Events
Time frame: 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.
12 secondary outcomes
Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor
Time frame: baseline and month 2
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
Time frame: baseline and month 2
Change in Ankle Inversion Strength Using Kiio Force Sensor
Time frame: baseline and month 2
Change in Ankle Eversion Strength Using Kiio Force Sensor
Time frame: baseline and month 2
Change in Ability to Perform Activities of Daily Living
Time frame: baseline, 2 months, 4 months, 6 months
Participant Frustration With Injury
Time frame: baseline, 2 months, 4 months, 6 months
Participant Perception of Recovery From Injury
Time frame: baseline, 2 months, 4 months, 6 months
Pain in the 24 Hours Following Running
Time frame: baseline, 2 months, 4 months, 6 months
Change in Running Duration: Weekly
Time frame: baseline, 2 months, 4 months, 6 months
Change in Running Duration: Longest Run
Time frame: baseline, 2 months, 4 months, 6 months
Change in Running Speed
Time frame: baseline, 2 months, 4 months, 6 months
Participant Confidence in Increasing the Duration and Intensity of Running
Time frame: baseline, 2 months, 4 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
Chronic Exertional Compartment Syndrome
Recruiting
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
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Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Acute Compartment Syndrome, Fracture, Bone
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Suer, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox in people with Compartment Syndrome of Leg, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: 2 months, 4 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.